CONCEPT
WHO adopted at 22nd Health assembly in July 1969 the Importance of GMP Maintenance of Quality of Pharmaceutical Products
Well accepted worldwide and most developed Countries have strengthened this with
statutes
Violations are severely dealt with
India- standards vary from State to State
GMP has become a part of Companys Philosophy and has its tacit acceptance
Consumer has the right to get best quality products for the price he pays
Manufacturer is responsible for the Product Quality and Performance
Product performance and bioavailability is paramount for cure of ailments
In India this concept is yet to find place
Having accepted this Philosophy, Company has to cater to
Continuous training & education of both present and new recruits
Continuously update the methods and incorporate the latest techniques
GMP is dynamic hence cGMP
Cost of failure is very high, hence adopt Prevention is better than cure proactive
Doing it right for the first time is most cost effective
Thinking starts from designing stage to prevent committing errors
Lay down right manufacturing procedures to be followed at the shop floor level
Conduct regular in-Company Self GMP Audit and implement course correction
GMP is more a Management Practice and an approach to Quality Assurance System
Merely complying to Statutes or GMP guide lines is not enough
Real success will come only if Concept of GMP is deeply ingrained in the minds of
people associated with the business, to make it a way of daily working life in the
Organization
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2. NOMENCLATURE
Analytical Method
A detailed description of the procedures to be followed in performing tests for conformity with
a Specification
Batch
A defined quantity of material or of bulk, intermediate or finished product that is uniform in
character and quality, and which has been produced during a defined cycle of manufacture.
To complete certain stages of manufacture it may be necessary to divide a batch into a
number of sub-batches, which are later brought together to form a final uniform batch. A
batch is sometimes described as a lot.
Batch Number (or Lot Number)
The designation of a batch by means of a distinctive combination of numbers and/or letters,
which identifies it and permits its history to be traced
Batch Manufacturing Record
A document stating the materials used and the operations carried out during the processing
of a given batch, including details of in-process controls, but normally excluding packaging
information. It should be based on the Master Formula and Method and be compiled as the
manufacturing operation proceeds.
Batch Packaging Record
A document stating the bulk product and packaging materials used, and the processes
carried out, during the packaging of a given batch, with details of in-process controls. It
should be based on the Master Packaging Instruction and be complied during the packaging
operation.
Bulk Product
Any product that has completed all processing stages up to, but not including, packaging
Contract Manufacture and/or Analysis
Manufacture and/ or Analysis ordered by one person or organization (the Contract giver) and
carried out by an independent person or organization (the Contract Acceptor).
Documentation
All the written production procedures, instructions and records, quality control procedures,
and recorded test results involved in the manufacture of medicinal product.
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Finished Product
A medicinal product, which has undergone all stages of manufacture, including packaging
In-Process Control
Tests made during the course of manufacture (including packaging) to ensure that the
resultant product will comply with its specification. Tests applied to the environment or to
equipment, as well as to products in process, may be regarded as a part of in-process
control.
Intermediate Product
A partly processed material which must undergo further processing before it becomes a Bulk
or Finished Product
Manufacture
The complete cycle of production of a medicinal product from the acquisition of all materials
through all processing and subsequent packaging to the dispatch of the finished product
(Unless the context otherwise requires, manufacture includes packaging).
Master Formula and Method
A document stating the starting materials, with their quantities, to be used in the manufacture
of a medicinal product, together with the manufacturing operations, including details of
specific in-process controls, but normally excluding packaging information.
Master Packaging Instruction
The instructions should include the method of assembling the component parts, if
the package is complex.
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Packaging Material
Any material used in the packaging of a product. The term is not normally extended to cover
the outer packing or delivery cases used for transportation or shipment of orders. The
categories of packaging materials used are:
Packaging materials which come in contact with the product (often called Primary
Packaging Materials)
Quality Control
Is that part of good Manufacturing Practice which is concerned with sampling, specification
and testing, and with the organization, documentation and release procedures which ensure
that the necessary and relevant tests are, in fact, carried out, and that materials are not
released for use, nor products released for sale or supply, until their quality has been judged
to be satisfactory. Quality Control is also used in the sense of the organizational entity,
which has the responsibility for these functions.
Quality Assurance
Is the sum total of the organized arrangements made with the object of ensuring that
products will be of the quality required by their intended use? It is Good Manufacturing
Practice plus original design and development. (Which may not strictly fall within the scope
of norms of GMP)
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3. HYGIENE
Objective
To avoid any sort of contamination, pharmaceutical products have to be produced with clean
materials, machines, and personnel. Personal hygiene therefore attains an important role in
GMP of Pharma Production.
Requirements of health, personal cleanliness, hygienic operation, protective clothing
applicable to all production people, maintenance staff and all other visitors have to be strictly
adhered to.
Scope: The scope covers
Personal Hygiene
2. Health
Written down requirements on minimum health requirements of all personnel working in
factory
Pre-employment medical exam, including eye, to be insisted upon, including temporary staff
Yearly Health checks up of all personnel including tests for communicable diseases.
Employees suffering from infectious disease like conjunctivitis, severe cold, should not report
for work
Employees reporting after absence from an illness involving communicable disease, should
not commence work, till assessed by Doctor
Staff should be encouraged to report infectious diseases, viz. Enteric and respiratory and
also any infectious diseases at home, so that temporary transfer to other departments can
be made.
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Staff trained to report boils, carbuncles, open wounds, or rashes on exposed parts of body.
Such persons must be excluded from operations involving direct contact with materials
Supervisory staff should be trained to look for such signs or symptoms of unhealthy
conditions of their staff.
3. Personal Cleanliness
Strict attention should be given to personal hygiene
Staff encouraged to have regular baths and change underclothes frequently
Hands to be cleaned regularly certainly after visiting toilet
Nails to be clipped regularly
Carbolic soap to be used
Hair should be kept clean. Males encouraged to be clean shaven, beards if kept, should be
covered
Wearing of jewelry viz. Bracelets, pendants rings, earrings etc. to be discouraged
Women operators should wear a minimum make-up.
False eye lashes, false nails, hairpieces, wigs or any other beauty aids, likely to fall into
product, not to be permitted.
Staff to be advised on use of suitable jewelry at work
4. Hygienic Operations
Food and drinks not to be consumed in production/operational/storage areas
This includes chewing of paan, betel nuts etc.
Smoking must not be permitted in any of the operational areas. No Smoking areas to be
displayed prominently at points of entry to such areas.
Food, drink and smoking material should not be stored in operational areas, which could
adversely affect product quality. Personal medication should not permit in such areas.
Protective clothing pockets should not be used for storing food.
Staff to be trained to keep working areas clean and uncluttered, and clean and clear away all
items before starting another
Staff trained to keep their lockers cleans and tidies. Unclean lockers source-contamination
5. Protective Clothing
Protective clothing is not only for individual but also for protection of product from the
individual.
No person should enter the production area wearing street clothes.
Clean working garments and protective apparels viz. head, face, hand, shoe and arm
coverings must be worn.
While handling dangerous or volatile materials, suitable additional devices such as head
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4. Hygienic Operations
Number of persons working in sterile areas to be kept to a minimum
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4. SANITATION
Cleaning agents
Disinfectants
Potent substances which destroy pathogenic micro-organisms but not necessarily resistant spores
Antiseptics
Reasonably non-toxic substances and can be applied to live tissues for killing microorganisms.
GENERAL PRECAUTIONS
1. Cleaning agents and disinfectants should be handled with care.
Manufacturers instruction- Use of protective gears viz. Gloves, eye-shield, aprons, safety
footwear etc.
3. Disinfectants containing alcohol or other inflammable solvents should be stored and handled
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in a safe manner.
4. Do not substitute Cleaning agents or a disinfectant- by another
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Cotton mops do not shed fibers- cleaned daily after use with soap water, and stored dry.
3. Vacuum Cleaners
Preferred to brooms and brushes- dust free and free from fiber and bristles.
Provide cleaning port lines to prevent cross contamination of main vacuum lines
Suitable for large manufacturing areas- but splash lot of water in surrounding areas, walls
Mop area and drain and clean mopped up water. Never store.
5. Jet cleaners
6. Brooms
Not recommended as produces dust, which gets dislodged from one place to other.
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General Requirements
1. All procedures should be documented in simple language- understood by operators.
2. Procedure should include
Areas & surfaces e.g. Floors, walls, windows, doors etc to be cleaned
Cleaning equipment
Frequency
Cleaning procedure
General
1. Frequency should be laid down
2. Long production campaign -frequency less and shorter ones more
3. Interval between two cleaning not more than 3 days
4. Through cleaning after every product change over
5. Clean walls etc. regularly, vacuum cleaned 3 monthly
6. Validated cleaning program - yearly
Liquid and Ointment areas
1. Spillage mopped up immediately- not at the end of each shift
2. Floor is cleaned with hot water at end of each shift. Attend to walls and floor joints.
3. Weekly - entire-manufacturing areas including walls, platforms, pallets, and drains should be
cleaned with hot water/cleaning aids, flexible hose. Scrubbing machines may be used
4. Cleaning to be followed by disinfecting- by agents effective on moulds/water borne bacteria
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5. Ointment base traps, drains, equipment, washing areas require special attention.
6. Broken glass pieces must be removed from filling lines immediately- nylon brushes/dust pans
7. Clean all drains at regular intervals.
8. Pass steam and disinfectant solutions in drain openings in manufacturing areas at least 3
times a day.
Tablet and Capsule Manufacturing Area
1. Spillage to be cleaned up immediately
2. Remove powders by suction followed by wet mopping
3. Tracking of powder from footwear from one department to another by operators- avoided by
using mats
4. Wash mats daily and dry.
5. End of each shift- floor, wall ledges, and machine cubicles - cleaned with vacuum cleaner.
6. Use of brooms to be discouraged- Corridors washed with hot water and detergent dried.
7. Advisable to disinfect floor, walls and ceiling to prevent moulds especially when Vitamins and
other growth promoting products are used.
8. Special attention during monsoon- cleans and disinfects more frequently to prevent mould and
fungus growth.
CLEANING SCHEDULE
General
1. Code of GMP- written procedures must exist for sanitation, with details of procedures,
schedule, materials, safety precautions, and responsibility etc. to be stated.
2. Methods and materials to use must be described.
3. Cleaning schedule for each area- summarized - methods, stating, daily, weekly, monthly, and
yearly.
4. Procedures would depend on scale of operation, size, complexity of facilities, nature of floors,
walls, ceilings, product mix etc.
Typical schedule
Liquid Oral Manufacturing Area
Daily
Damp mop all accessible area-twice a day with cotton mops and 0.5% teepol (neutral
detergent) solution.
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equipment, work tables, telephones etc. with wet mop followed by drying.
Clean platforms and all surfaces, using scrubbers. Hose down the platforms and walls-
Friday
Clean walls, platforms, floors using mechanical scrubber, hose down all surfaces with water.
Use suction floor drier to remove water. Wipe with 0.1% Sodium hypochlorite sol, allow
drying.
Scrub equipment, washing area with powder, hose down and dry.
Fortnightly
De-dust all ledges, windows; exhaust fans, light fixtures, and insceticutors, with vacuum
cleaner.
Damp-wipe all fixtures with sponge using 0.1% Tee pol solution.
Monthly
Clean with 0.1% detergent in hot water all surfaces including ceiling.
Dust all shelves, floors, and walls, weighing scale with vacuum cleaner.
Quarterly
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5. TRAINING
SCOPE
Policy applies to all employees, including contract and temporary staff, production, testing,
distribution, (related activities) and marketing of products produced by the Company.
POLICY
Company must identify positions in Organization- performance may affect product quality.
Management responsible to ensure he has right Education - Training - Experience
Training must cover
SCOPE
1. Content of training program must include
2. Special emphasis on training of staff working in aseptic areas, including housekeeping and
engineering staff
3. Special training for operators handling highly toxic or potent materials
4. Program should monitor effectiveness of training periodically
5. Emphasize on retention of production records for a definite period of time
6. Enable to
Review draft, approve, monitor the adequacy of standard Operating Procedures from
time to time
7. Monitor and ensure that validation of production process and equipment are adequate
8. Ensure that all significant changes to validated process, facilities, equipment, materials,
manufacturing steps, computer control systems, utilities are subject to comprehensive review
and approval by designated authorities including quality control personnel.
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REQUIREMENTS
All personnel involved in processing a drug product must have
1. Appropriate level of education, training and experience to enable them to perform the job
adequately
2. Training must be in areas specific to their responsibilities
3. Trained in GMP before they perform the job and subject to periodic re-training
4. Trained in safety procedures before they perform the jobs, and receive periodic re-training
5. Special training for personnel working in hazardous areas or controlled environments e.g.
Clean rooms, sterile areas, handling toxic materials, on how to minimize risk to personnel
and drug products.
FREQUENCY
After induction a follow-up training at sufficient frequency to ensure that employees are
familiar with latest GMP requirements.
The frequency will also be decided based on the results of self-GMP audit conducted by the
Company.
EFFECTIVENESS
Should be evaluated to ensure that the requirements are fully met with
DOCUMENTATION
Training program must be documented and records maintained to demonstrate that
1. All personnel - capable of performing their assigned tasks
2. All processes are carried out by appropriately qualified and trained personnel
3. Maintain records- contents of training program both in-house and external- received by the
individual employees
4. Maintain records- for a definite period of time depending on the Companys Policy.
MANUAL OF INSTRUCTION
1. Training manual - updated from time to time incorporating additional requirements of the
Company
2. An appropriate person- designated to oversee needs of Company - updating and issuing
instructions to participating departments
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6. CALIBRATION
Preamble
Used to measure and record conditions and control various processes set to preset
parameters
Conditions are very critical for the product quality and inaccuracies - can mare the effect of
product
Objective
Procedures
The normal activities are
1. Documentation Program
2. Identification systems
3. Calibration Control Mechanism
4. SOPs for Calibration
5. Calibration Data Sheet
6. Handling and maintenance of Test Standards
7. Calibration Certification requirement
8. Pre-purchase Review of new Instrumentation
9. Review of Calibration Program
10. Training of Technicians
1. Documentation Program
i)
Specifications
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Item used
Environmental condition
Identification No
Calibration Status
Calibration Frequency
Calibration site
Calibration dates-Instruments tagged with ID No. Date and review due date
Calibration date review- immediately against standard. Results within limits or not should
be reported
iv) Documentation: This should include standard specification, raw data sheets, and the
calibration certificate
2. Identification Systems
PR-RT2- TI6
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3.1.
Reference calibrating equipment available with approved National Laboratories- normally 4 times
more accurate than transfer standard
Equipment used to calibrate measuring standard equipment- 4 times more accurate than
measuring Standard
Measuring Standard
Classification of Instruments
3.3.
Calibration intervals
3.4.
3.5.
3.6.
3.7.
Damaged Instruments
Should be removed till they are repaired
Documentation
Instrument standard specification and raw calibration are used to support Calibration
Control Mechanism.
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3.8.
Calibrating equipment
Primary reference Standard, Transfer Standard that is calibrated using primary reference
standard
Universal Calibrator
Pressure/Vac. Gauge
Digital Equipment
Autoclaves/Sterilize
Temperature Gauge
pH meter
Procedure
1. Connect the output terminals of the temperature calibrator to the inputs terminals of instrument
2. Apply appropriate millivolt (taking cold junction compensation i.e. CJC into account) or
resistance corresponding to the ambient temperature.
3. Observe reading on the display and compare it with ambient temperature.
4. Adjust potentiometer marked AMBIENT if required and bring the reading and display, to the
ambient temperature.
5. Apply mille volts (taking CJC into account) or resistance corresponding to the full span in
operating range of the instrument.
6. Observe reading on display
7. If the reading differs from actual span, adjust potentiometer marked span till display shows
exact span reading
8. Apply requisite millivolt (taking CJC into account) or resistance corresponding to 0%, 25%,
50%, 75% and 100% of the range of the instrument and note the readings observed on
display.
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9. Apply proper millivolt (taking CJC into account) or resistance corresponding to 100%, 75%, 50
25%, and 0% of the range and note readings
10. Observe deviation of the actual readings from set values
11. If relationship is nonlinear, adjust the potentiometer marked LINEAR if any.
12. Repeat steps (2 to 11) till proper ambient span adjustments and linearity are observed.
13. For controllers, adjust the set point to 25% of the operating range.
14. Apply proper millivolt (taking CJC into account) or resistance corresponding to a value which is
more than 25% of the range
15. Confirm that output relay is operating
16. Change set point to 50% of the range and repeat step 14 and 15
5. Calibration Data Sheet
Type of Instrument:
a) Instrument Identification Number:
Description
Model No.
Serial No
Range /Scale
b)
Description
Model No
Serial No
Precision/Accuracy
Humidity
Pressure
Calibration Frequency
j)
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Model No
Serial No
Precision/Accuracy
Serial No
Range/Scale
Model No
7. Summary of data at various data collection intervals and the correction value for both
instrument and standard
8. Environmental conditions
9. Calibration frequency, next due date and exceptional conditions
10. Name and signature of calibrating technicians
11. Summary of report and audit findings
8. Pre-Purchase Review of New or modified Instruments
8.1. Instrumentation Review
a. Determine what instrument is expected to do, capacity?
b. Determine how functions, what control mechanisms.
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Amendment in new SOP will succeed the old one, and recorded.
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7. CONTAMINATION CONTROL
FEATURES
PROCEDURES
1. Receiving
Pre-entry Cleaning
SOP to followed
2. Sampling
3. Dispensing
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4. Production
5. In-process Control
Extra vigilance required - product with same color and similar appearance
6. Work in process
7. Packaging
Primary packaging components - bottles, caps -handle for one product at a time.
Common Component- Surplus quantities issued for one product- cannot be used for
another product
8. General Precautions
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8. VALIDATION
MEANING
Validation to prove that a process works using scientific and statistical principle to produce
acceptable product.
OBJECTIVE
Validation determines process variables and set acceptable limits -in process controlsspecifies
BENEFITS
1. GUIDELINES
ii.
iii.
2. APPLICABILITY
Process validation expects qualification
2.1. Analytical quality test procedures
2.2. Instruments
2.3. Personnel
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Steam
Compressed air
Drainage system
2.1.
2.2.
Instruments
Many processing instruments used- Calibration is essential- thermometer, pressure
gauges, relative humidity meters, conductivity meters, timers, and alarms.
2.3.
Personnel Qualification
Untrained persons can negate work done in qualifying process and other components of
process
2.4.
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2.5.
Written procedures available for each operation of equipment and process step
Computer controlled equipment challenged to ensure that system will work under variety
of conditions
2.6.
Flow of material
2.7.
Water Qualification
Frequency of inspection of filters, DM units, traps, storage tanks, distribution pipe lines,
valves etc should be established and documented
Use seamless pipes for DM, water for Injection, & sloped
Storage of Water for Injection to prevent stagnation water and microbial growth
2.8.
Manufacturing Process
Every formulation must have a Master Formulation Order, specifying raw materials,
quality, quantity per lot, approved by responsible persons
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2.9.
Component preparation
pH meters, balances, conductivity meter calibrated
Materials issued are countersigned
Identify and dedicate containers with proper labels
Compounding
Equipment clearance before use
Environment controls as per GMP
Compounding parameters within limits
Blend uniformity
Sterile filtration
Manufacturers Quality Assurance Certificate for filter
Check Integrity of filters before use
Ensure filter sanitation frequency
Check UV lamp intensity testing and replacement frequency
Filling
Filling under aseptic conditions
Filling heads deliver predetermined volumes
Sealing
Sealed containers are leak tested
Particulate inspection
Examine units under black and white background
Packaging
Line clearance obtained before starting
Verify stereos used for overprinting- current product lot
2.10.
Product design
Manufacturing procedure validated for Product Development- at least three pilot lots
produced
Fix tentative limits for critical variables- modified after stability studies
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Untreated water - non-potable for non-critical use e.g. fire fighting, cooling water
1. Responsibilities
a. Head of manufacturing unit to ensure water systems are designed and operate under
standard conditions
b. Plant Engineer -written instructions- inspection of water systems, pumps, treatment
plants, traps, tanks, line
c. Cleaning and sanitizing systems, frequency
d. Corrective actions, if quality fails
e. Water system should indicate, source, treatment, storage, distribution, outlets,
drainage and sampling
f.
Water for Injection- Meet standards- prepared by distillation of potable water- prevent
entertainment
g. Water for final Rinse- same chemical/microbial quality as WFI - not necessarily
prepared by distillation
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1. Coarse Filtration
Deionization (CDI)
2. Carbon Beds
6. Reverse Osmosis
3. Chemical additives
7. Ultra Filtration
4. Water Softeners
8. Distillation
1. Coarse Filtration- Remove coarse particulate > 10 microns prevent damage to system.
Cause microbial growth, blocking. Back washing important
2. Carbon Beds- Remove organic and oxidizing chemicals- absorption, Control includes, steam sanitation, stagnant conditions leading to biofilm- monitoring
3. Chemical additives- oxidizing agents for microbial control, sod hypochlorite, chlorine,
flocculating, and sodium bisulfate, Control levels to prevent excess of additives
4. Water Softeners- Resins to remove cat ions and anions (cal and Ma) -protect downstream
units i.e. RO membranes, deionization resins and stills
6. Reverse Osmosis (RO) - Uses high-pressure differential to force water through semipermeable to remove chemical, microbial and colloidal endotoxin. Failure of membrane to
be detected
8. Distillation- Reliable method for WFI, Main concern is entrainment, flooding, and variations
during start-up operation and contamination of steam. Eliminated through continuous
conductivity sensing and monitoring
10. Ultraviolet light- Low microbial maintained by using wavelengths of 254 nanometers with
a residence time of 15 seconds, Good for maintaining low levels but not well for major bio
burden. Replace bulb regularly.
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Approaches:
Storage at 75 to 80 C
5. Microbiological purity
Limits for microbial contamination are set for
Drinking Water
Purified Water
WFI
Establish Test frequency- potable and purified water weekly. WFI - twice a week
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Sterile Products are free from microorganisms, pyrogen, with high standards of quality
and purity
Greater significance- maintaining high standards for sterility- than on End product testing
Ensure design parameters and setting up practices and precautions and following them
consistently meet conditions.
Maintain air pressure differentials to prevent flow of air between gowning areas to other
areas.
Adequate facilities for washing, disinfecting, drying hands, storage of clean sterile
garments and disposal of used garments
Access to clean and aseptic areas only through change room, the general procedure
Change over from street clothes to factory uniform and footwear
Wash hands and feet with soap and water before putting factory uniform
Air pressure differentials should sweep air from aseptic area to change rooms and
non-sterile corridor
Doors of change room not to be opened simultaneously before entry/exit to sterile
area
Stagger entry- pre-determines no. of persons using room minimum
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ENTRY PROCEDURES
First Change Room
Remove factory clothing and footwear. Keep at the designated proper place
Disinfect arms up to elbows and swab feet with disinfectant solution. Renew disinfectant
solution.
Before entering second change room, stand on a mat soaked with antiseptic, kept at the
entrance
Push door open with elbow, without contaminating wet hands, and ensure first entrance
door is shut.
Dry washed hands and arm with foot-operated hot air drier. Pick up sterilized garments
and put on as follows
Sterilized head gear (hood, stored under UV lamp) should be put on first, covering hair,
nose and mouth
Put on sterile suit or tunic, so that the lower end of hood is tucked to neck of suit, with
arms gathered at wrist.
Put on sterile trousers so that they cover lower portion of suit. Trousers should not
sweep the floor, but gathered at the ankle.
Pick up sterilized booties and put them while crossing over a step-over bench provided in
the room. Tuck in the trouser bottom inside bootie, which is then laced up.
Insert the booted feet into footwear reserved for use in sterile area and previously
washed. Put on visor goggles
Swap gloves with alcohol or antiseptic, enter aseptic room, by pushing doors open with
elbow
End of work, remove gloves and deposit for washing. Change garments in reverse order
and deposit for washing. Gowns may be kept under UV and during short breaks
Mandatory to display gowning procedure in change in the form of display and sequence
of changing
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Operators working in clean and aseptic areas should open and shut doors gently. Do not
rush or run in the rooms and avoid talking
Formaldehyde is irritating to eyes and skin. Rubber gloves and goggles must be worn
37% formaldehyde solution is placed on stainless steel container with perforated lid.
Place container on hot plate. Put off blower during fumigation
Seal off entrance to areas and leave it undisturbed for some time to ensure proper
sterilization
Prior to fumigation entire area must be cleaned and sanitized. Put off air supply and UV
lights
Formaldehyde vapors are effective at a relative humidity of not less than 50% at 25c.
Monitoring humidity and temperature during fumigation is essential.
After exposure for adequate time interval, put on exhaust fan. Room is flushed with clean
filtered air.
Switch on UV lamps
Expose nutrient agar at various locations, to ensure that microbial load is within limits.
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Date of Issue
Revision No
CLEANING SYSTEM
Equipment to be cleaned
Product contact surfaces must be smooth, non- reactive and easily accessible and nonPage | 36
absorbent
SELECTION OF CLEANING AGENTS
Cleaning agents must fulfill:
Non- corrosive
Anti-microbial in nature
Baffle plate-to prevent contamination from mixing rotor - is a major source where
particles can accumulate
Sampling Methods
Swab Technique- Potential areas swabbed with cotton swab wetted in solvent and
extracted in same solvent and tested. Useful in determining microbial residues
Solvent Rinse Method- Rinse with solvent of known volumes given to the cleaned
equipment and aliquot analyzed for residues
Placebo Rinse Method- Residues which are difficult to flush out are removed by
duplicating process with a placebo and analyzing the residues
Cleaned parts to be covered and stored in dust free area and properly labeled
All dedicated manufacturing lines, end of last shift or weekends- through cleaning
Carry out swab test on all cleaned equipment for residues of previous product
Swab/rinse tests revalidated for product change over on non-dedicated lines every three
months or earlier
For products containing steroids or biologically active materials, swab tests done after
every change over
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Requirements
Examination and usage
Different products must have distinct appearance for labels and packaging materials.
Educate the supplier to take adequate steps to prevent mix-up at stage of printing.
Steps taken to ensure work area clean, clear and free. A line clearance to be performed
Filling and sealing followed by labeling, if stopped, adequate care taken to prevent mixup
Packaging Specification
Use of right packaging materials is very important for quality of the final product. Guide lines are:
Master Packaging Instructions should be created. Listing all components with their
specifications to be used
For every product, all components to be listed in detail along with coding and over
printing instructions
LINE CLEARANCE
Important to inspect packaging and labeling facilities and clear all materials before starting
Filing/Packaging line and areas close to it should be cleared of materials from previous
product
Rejects, inadequately filled bottles, broken or damaged packs, strips, empty pouches,
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should be removed
After satisfactory line clearance, relevant details filled in and initialed by supervisor, in
order format
Filling or packing should not commence before satisfactory checking and line clearance
PACKAGING INSTRUCTIONS
At times variations are required depending on market needs for each product. Such variations
should be clearly stated. Normal details:
Name of Product
List of materials required for standard batch size, code reference number for each
specification
Overprinting details, batch no. date of manufacture, expiry date, retail price, physicians
sample- not for sale
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Coding of Inputs
1. Supplier
2. Packaging materials
Coding by Receiver
On receipt of material
System should provide complete history of Lot till consumption and disposal
Bar Code:
Single code Bar- Printed at the edge of materials viz. Labels or carton. Bars provide
check and prevent mix-up and easy to inspect
Multicolor Bars- Help to quickly check all colors of a multicolor are printed or not
Spacing and location of Bars- Distinct shift in position of code bars, size, and spacing
between consecutive bars are helpful in establishing conformance to standard.
Cyclic codes- Help in establishing period (a month) when component was printed.
Used normally in paperboard cartons clock in inner flap indicate month of printing.
Supplier code- Asked to incorporate a logo
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Batch coding:
Provisions of Drugs and Cosmetics Rules 1945 are applicable. How the conditions are left to
the manufacturer.
Operational convenience
Subsequent documentations at stages viz., excise, invoicing, to stockiest/ trade must not be
over looked
Page | 43
Objective
General Guidelines:
1. A minimum value of material below which re processing not to be considered to be set
2. Investigate reasons for out of specifications to minimize recurrence.
3. Maintain register giving quantities and reasons
4. Re processing or re labeling should be rare
5. Normal manufacturing process applicable unless evidence to prove alteration of quality,
shelf life and stability
6. Re processing method to be authorized and documented, after potential risks evaluated and
found negligible
7. Need for additional testing of reprocessed product to be considered viz. Re grinding and re
granulation of tablets affect tablet dissolution
8. At times original release specifications of product may not be applicable. Revise
specifications. Review constantly quality of re processed products.
9. Residues and reworked or recovered material may adversely affect product quality. Must not
be used in subsequently batches.
10. Deciding factor for use or not is the stability of batches containing known amount of
residues.
11. Collect stability incorporating varying amounts of residues of varying ages.
12. Stability profile should not be different from standard batches without any residues
13. If stability is different, ascertain period for which product will meet end of life specifications.
Life period of such batches to be suitably amended.
14. If sufficient quantities can be re processed into are processed batch, discard residues from
re processed batches
15. Residues from inspection stage containing foreign matter viz. Metal particles should not be
re used.
16. Batches containing residues are not released by QC, until batches from residues came are
fully tested and certified for use.
Page | 44
Specific Requirements:
Method of handling residues, additions to fresh batch are documented and approved by the
Quality Control Manager
Batch Manufacturing records should indicate that the batch contains residues, with the
details of origin of residues, and quantities used
Any reduction of normal shelf life recommended by quality control should be recorded, in
batch packaging Order and labeling order instructions
Page | 45
15. WAREHOUSING
OBJECTIVE
To provide adequate facilities and systems for storage, handling of raw and packaging
materials required for manufacture and packaging of Pharmaceutical Products
SCOPE
Guide lines for receiving, verifying, inspecting, all incoming raw materials
General Guidelines:
1. Receive materials against specific supply advice (Purchase Order)
2.
Name of material
Name of manufacturer
Date of receipt
Under Test
PREMISES
Must have separate areas suitable size, and construction for
Storage (including specified air-conditioned, cold rooms, store for hazardous chemicals)
General storage area or special storage depending on material and required conditions
Segregation
1. To be sampled
2. Under Test
3. Approved
4. Rejected
5. Storage area for hazardous materials with restricted entry
Premises
Warehousing Procedure
Stocks received against proper documents with all details viz. Batch No., quantity, Analytical
reports
Order require dispatch of variety of products, arrangement for order picking and assembling
Picking and assembling of order done against a standard, dated, serially numbered
documents
Page | 49
Returned Goods
Weighing of materials
General Guidelines
Choose right type of balance- minimum weight should reflect error. Follow guide lines of
manufacturer
When two or more lots are used- record amounts from each lots
Name of material
Page | 50
SCOPE
Provide clear guidelines for
1. Classification of returned goods
2. Responsibilities/Authorities for dealing with such situations
AUTHORITY AND RESPONSIBILITY
Documented
Inspected
Accounted
Contents destroyed so that Product not usable in any manner what so ever
All primary and secondary container with printed matter destroyed to render them unusable
If felt, that the damage to primary container can make the contents unusable/unsafe,
contents shall be destroyed.
To be destroyed
Mutilated labeling:
Product unidentifiable
To be destroyed
Returned Goods:
Dealt separately
Page | 52
OBJECTIVE
Define a system for
Assign responsibility for implementation once decision of recall has been made
There must be a written and approved procedure of a person responsible for initiating recall,
sampling from market.
Evidence that continued presence in market can pose risk to health to the use
Product complaint from field staff referred to QC Dept. for investigation, recommendation
Batches of product found not satisfactory, evaluated for level of re call (In Company,
wholesale, retail)
Any notice of recall from drug control Authorities in house investigation completed within 2
days, unless special reasons- and longer investigation time
The committee shall designate one person to co-ordinate all activities on behalf of the
Company
Page | 53
RECALL PROCEDURE
Designated member shall be responsible for taking all actions for speedy, efficient and
effective recall.
Confirmation should be received that stocks are frozen and kept under quarantine
If product defect is life threatening- public announcements to be made to reach retail outlets,
hospitals, Doctors and even individual users.
Designated member of co-ordination committee shall liaise with Drug Regulatory Authorities
Recall affected as per directive from Drug Control agency on life threatening situations.
Approval for disposal/destruction to be obtained from Drug Regulatory Authorities
Recall co-ordination committee shall decide on the most effective and safe disposal of
recalled stocks, including packaging materials to make them unusable
i.
ii.
Recall committee shall finally review complete recall operation, including documentation and
close the recall as RECALL COMPLETED
Page | 54
SCOPE
RESPONSIBLITY
REJECT/SCRAP GENERATION
Rejects generated systematically collected and accounted to prevent misuse
Rejections during compression, encapsulation, coating, filling, inspection, & packing stages
Excess of rejected printed packaging materials coded or non-coded viz. Labels, cartons,
leaflets
GENERALPRINCIPLES
Quantities rejected and destroyed should be recorded and reconciled in relevant batch
documents
Final disposal of solid/liquid residues should comply with local requirements including effect
on environment
S. No.
Type
Method of Destruction
1.
Empty containers
Deface Labels
2.
Incinerate Solids
3.
4.
5.
Injectables in ampoules
6.
Injectables in vials
7.
Granules/tablets/liquid in bottles
8.
9.
packs
Ointments/Cream
treatment
10.
Ointment/cream tubes
11.
Labeled ampoules/vials
Crushed
12.
Labeled bottles
13.
14.
Cutting/shredding/defacing
15.
ROPP seals
Crushing
Page | 56
OBJECTIVE
SCOPE
SPECIFICATIONS
1. Written specifications for each material authorized by Quality Control and to be reviewed
periodically
j.
Specifications for limits for purity, physical and chemical characteristics, microbial
standards and assay
Page | 57
Page | 58
SAMPLING EQUIPMENT:
1. Material of construction should not affect or contaminate sample taken- Stainless steel/
Plastic are considered suitable
2. Sampling equipment should be cleaned and dried before use
3. For microbial contamination- equipment should be sterilized before use.
4. Sample containers should be labeled and should be of right type and size
5. Suitable carriers viz. Baskets should be used
6. Containers should be wide mouth, amber or colorless bottles, with screw caps and inert
wads.
7. For hygroscopic materials- tight fitting polythene liners are used before caps are fitted
8. Containers for liquids- ladles of stainless steel with spout at right angle to the handle are
used. Valve sampling cylinders and sampling tubes of glass or metal are employed
Page | 59
SAMPLING PERSONNEL:
1. Trained for the purpose. They should be observant, meticulous and have the ability to
understand the nature of material they are handling.
2. Should be familiar with precautions to be taken while handling hazardous and sensitive
materials
3. Staff to wear protective clothing
4. Sampling staff are accountable to Quality Control Manager
PRECAUTIONS:
1. Wear proactive clothing while handling hazardous materials
2. First Aid instructions should be at place of sampling
3. Before sampling- ensure sample containers show
a. Name of material sampled
b. Identifying mark of material container from where the sample is taken
4. Open containers carefully and re seal
5. Samples should be returned to work points where taken
6. Volatile materials samples, to be filled to 70% of container volume
7. Spillage to be cleaned up immediately and disposed off safely
8. Sterile materials to be sampled in such a manner that they do not become non- sterile
SAMPLING PLAN
1. Extent of sampling depend on each consignment
2. Sample as many containers as practical, at least square root plus one of No. Of containers
in a batch. If less than 5 containers, then, each container to be sampled
3. Random sampling of containers without reference to sequence. Damaged containers to be
sampled separately
4. Every batch of material in consignment to be sampled
5. Quantity of sample taken should be sufficient for control and reference purposes. Normally
twice the requirement is taken as samples
6. Sample in two separate parts- later test, use from unopened container
SAMPLING PROCEDURE
1. Note condition of container with proper labels
2. Examine material from top and bottom for contamination. Look for variations in color,
infestation, and extraneous matter.
3. In liquids- look for presence of suspended matter or sediment
Page | 60
PACKAGING MATERIALS:
Any material used to package a drug viz., bottles, vials ampoule, tin, tube, and foil
Wrapping, cartons catch cover including stuffing used
Labels, leaflets
SPECIFICATIONS
1. QCM in consultation with production Manager lays down specification for all packaging
materials
2. Specifications shall include
a. Name of material
b. Description
c. Dimensions
d. Tests for compliance
e. Instructions for sampling
f.
Storage conditions
g. Frequency of re-examination
h. Date of Issue of specifications
i.
Approval by QCM
SAMPLING
1. Component materials- done a statistical basis
2. Other packaging materials- Experience of the user.
TESTING
1.
INSPECTION
1. Appearance
2. Color
3. Quality of print
4. Self locking ability
5. Dimensions- body length, cap length, body diameter, cap diameter, unclosed and closed
joined lengths
6. Smoothness of separation of unclosed capsules
7. Classification of defects- Critical/Major/Minor
TESTING
1. Moisture
2. Weight of shells- random samples of 100 capsules
3. Disintegration time- by Pharmacopoeia methods
4. Machine trials at least 1000 capsules
INSPECTION OF GLASS BOTTLES:
SAMPLING
1. Select 4 cases of boxes at random
2. Visually examine sample of all bottles
3. Dimensions- Net finish and diameter 20 bottles
Internal bore diameter- all bottles top layer
Other dimensions 20 bottles from 4 cases
4. Overflow capacity- 3 bottles at random from each case
INSPECTION
1. General conditions of cases
2. Open cases inspect requisite no. Visually
3. Check neck finish
Page | 62
SAMPLING
Intermediate Product
o
Sampling done based on previous experience or square root plus one of total no. Of
containers/batch
Finished product
o
Beginning and end. Preferably throughout the operation- ensure statistical control
Testing
o
PROCEDURE
1. All complaint should be brought to attention of QCM
2. Complaint Form should be used giving the following
a. Name and strength of product
b. Batch No.
Page | 63
RECORDS
Detailed records maintained and should be available for inspection by authorities
STABILITY TESTING OF FINISHED PRODUCTS
Tablets
Capsules
Ointments
Purity
o
Potency
o
Date of sampling
g. Record of testing
a. Date of receipt of material
b. Name of material on the invoice/challan
c. Suppliers /manufacturers batch Ref. No.
d. No. Of containers
e. Batch identifying No. Assigned
f.
Date of sampling
g. Record of testing
Date of testing
Results of tests
Signature of person
performing the test
PACKAGING MATERIALS
Same as above
RETENTION OF SAMPLES
As per Drug Rules
RESERVE (RETENSION) SAMPLES
Mandatory to retain samples till designated shelf life
RAW MATERIALS
1. Sample from each batch of raw material from each delivery
2. Quantity twice than required for each test
3. Container should preserve quality and integrity
4. Period vary from two years after use or one year after expiry
PACKAGING MATERIALS
Specimen sample of printed packaging material to be maintained
FINISHED PRODUCT
1. Sample kept in same container as the one in which it is marketed
2. Quantity is twice than required for each test
3. Reserve samples to be stored at
Cold
Cool
between 8 and 25
Warm
above 40C
Several tests are carried out during course of manufacture to ensure that the final product
will comply with its specification
1. Visual inspection of injection against illumination
2. Leak testing of filled ampoules
3. Testing of membranes filter
4. Tablet compression
a. Weight of tablets
b. Hardness of tablets
c. Thickness of tablet
d. Friability of tablet
e. Disintegration time
5. Strip sealing
Page | 67
Unplanned departure from written down procedures can occur. If deviations do not affect
product quality or safety and decided to accept, a written procedure is required to be
established.
The purpose is
Inform responsible individuals of the occurrence of such deviations
Suggest method of disposition of material
Helps in initiating corrective actions
SCOPE
Applicable to all materials, packaging material, semi finished product and finished product
PROCEDURE
1. When unplanned departure from laid down specification procedure occurs, a deviation
request can be raised
2. Request from any department, except from Quality Control department
3. Request raised on Deviation Approval Form by concerned department after completing
Description of non- conformance and probable reasons for deviation
4. Following departments are consulted before accepting
a. Quality Control
b. Research and Development
c. Manufacturing
d. Marketing (when required)
e. Purchase (when required)
f.
5. QC shall record Recommended Disposition and proposed corrective action and return
to concerned department for action
6. The concerned department will initiate the necessary action and confirm same to Quality
control who will record the same on the Deviation Approval Form
7. Duly completed Deviation Approval Form will be retained by QC department
Page | 68
Item
Request No
Quantity
Date
Value Rs
Originating department
Description of no- compliance
Reasons for deviation
Recommended disposition
Corrective action
Approvals
Department
Acceptance Y/N
Signature
Date
Page | 69
STABILITY STUDIES
1. Stress testing
2. Formal studies
Shows that drug substance will remain stable within specifications under
recommended storage conditions
3. Selection of batches
At least 3 batches are subjected to short term (accelerated) and long term
stability
5. Specifications
6. Storage conditions
7. Frequency of testing
8. Containers
9. Evaluation of results
10. Labeling
OBJECTIVE
Stability behavior of a chemical (drug substance) as a raw material is only an indicator of
behavior as a part of finished product (formulation). Product stability also influenced by
method/process of formulation
SCOPE
Guide lines for conducting, evaluating and reporting stability studies
STABILITY STUDIES
1. Selection of Batches
3. Specifications
Long term
Accelerated
5. Testing Frequency
Testing for every three 3 months over the first year and then annually
Page | 71
6. Packaging materials
7. Evaluation
8. Statement/Labels
Page | 72
22. DOCUMENTATION
OBJECTIVE
SCOPE
Covers all aspects of Pharmaceutical Production
1. Buildings & Premises
2. Personnel
3. Equipment
4. Materials
5. Processing
6. Finished Goods
GENERAL
1. Designed with utmost care for effective use
2. Each document will have
a. Clear title
b. Identification No.
c. Approval of authorized person
d. Date of issue
3. Instruction given in documents should be precise and not ambiguous
Instructions shall be for each individual step and not combined
4. Document
a. Should provide sufficient space for making entries
b. Shall indicate what is to be entered,
c. Who is responsible for entries
d.
e.
9. Documentation through electronic media, adequate and reliable. Systems to checka. Ensure correctness of data
b. Record changes(additions/deletions)
c. Restrict access only authorized persons
10. Documents retained should permit
a. Quick, easy and reliable retrieval of data
b. Allows review up to a pre-determined time in past
c. Meets regulatory requirements
Page | 74
Product and Batch Specific document giving reliable information on history of each batch
of every product.
Documents are used in the shop floor and instructions should be clear and precise
Page | 75
SCOPE
RESPONSIBILITIES
METHODS
1. Self inspection/Audit shall be independent and impartial
2. Check list shall be drawn for each audit
3. Check list shall be area specific/Operation specific so as to make the exercise of self audit
more focused
4. Self audits shall be conducted at reasonable intervals, but should cover area at least once a
year
5. If need arises. A specific area/operation shall be audited more frequently
6. Findings of Self audit shall be recorded
7. Self-Audit reports suggest corrective actions and assign responsibilities for implementation
8. Systems should provide status of implementation
CHECK LIST- SELF AUDIT- DISPENSING OF RAW MATERIALS
ANNEXURE I
YES/NO
RECOMMENDATION
ANNEXURE II
1. No Quarantined Labels
Wrapped
4. Rejected packaging materials are
Stored in the same area along
Manager Production
Action Plan
Manager- Production
Report Date
*Finalized after discussion between Audit team and Area Supervisor/ Manager
Page | 77
SCOPE
To recommend
1. General conditions, both technical and commercial as part of contract
2. Technical guide lines for selecting a Contract Manufacturer
3. Quality assurance systems to be considered while drawing a contract
Page | 78
QUALITY ASSURANCE
1. Manufacturing procedure to be fully documented
2. Materials and product specifications
3. In process controls
4. Responsibilities, individual or joint assigned
5. Documentation system to be discussed and agreed
6. Equipment and facilities, testing procedures to be validated
Page | 79
OBJECTIVE
To derive benefits suitable and properly trained and motivated staff is essential
EQUIPMENT
1. Should be serviced and calibrated at suitable intervals and records maintained
2. Instructions available for operating each item of specialized equipment
3. Suitable arrangements made for protecting sensitive apparatus against humidity,
temperature, vibration
4. Warning provide to indicate failure of important services viz., fume
Cupboard extract
SAMPLING
1. Samples taken should be representative from which they are taken, and should as
Per written instructions
Page | 80
TESTING
CONTRACT ANALYSIS
1. Although analysis may be undertaken by a Contract Analyst responsibility for Quality Control
cannot be delegated
2. Nature and extent of any contract analysis to be undertaken should be agreed and clearly
defined, and sampling procedure should be set.
3. Contract Analyst to be supplied with details of test methods relevant to the material under
examination.
4. Formal arrangement to be made for retention of samples and of records of test results
Page | 81
Quality management
As aspect of overall management function that determines and implements the quality policy
Gain confidence of customers that quality has been or will be achieved and maintained
3. Support managements confidence that quality system has been installed and is effective.
ADVANTAGES
1. Can become profitable
Poor quality cost billions of Rupees each year.
Getting it right for the FIRST TIME is cost effective
2. Motivation of Staff: No rectification of defects.
Setting up standards by involving staff
Higher productivity results in higher earning
3. When approved- Company appears in Department of Trade and Industrys Register of
Approved Firms
4. Certified Companies are permitted to use Approved Firm Logo
Attracts fresh business
5. Gives international recognition
DISADVANTAGES
1. Implementation of formal quality system is demanding on resources. Involves considerable
expense and is time consuming
2. Unless carefully planned it can become non-cost effective and burdensome.
3. In the absence of an attitude conducive to change and improvement, the process can become
traumatic
4. Need to change attitude and accept new working practices may strain the management
capability of Company beyond its ability to cope.
5. ISO 9000 certification is expected to eliminate second party assessment- may not be the case
initially.
6. ISO 9000 only supplements and compliments product quality- but does not replace them.
Page | 82
QUALITY VOCUBULARY:
Quality
Quality is the totality of characteristics of an entity that bare on its ability to satisfy stated and implied
needs
Inspection
Inspection is the activity such as measuring, examining, testing, or gauging one or more
characteristics of an entity and comparing the results with specified requirements in order to
establish whether conformity is achieved for each characteristic.
Quality Control
Quality Control is the operational techniques and activities that are used to fulfill requirements of
quality
Quality Assurance
All the planned and systematic activities implemented within the quality system and demonstrated
as needed to provide adequate confidence that an entity will fulfill requirements of quality.
Quality Planning
Activities that establish the objectives and requirements for quality and for the application of quality
system elements
Quality Policy
The overall intention and direction of an organization with regards quality, as formally expressed by
top management
Quality Plan
Document setting out the specific quality practices, resources and sequences of activities relevant
to particular product, project or contract
Quality Management
All activities of the overall management function that determine the quality policy, objectives, and
responsibilities and implement tem by means such as quality planning, quality control, quality
assurance and quality improvement within the quality system
Page | 83
Quality system
The organized structure, procedures, processes and resources needed to implement quality
management
Quality audit
A systematic and independent examination to determine whether quality activities and related
results comply with planned arrangements and whether these arrangements are implemented
effectively and are suitable to achieve objectives
Quality surveillance
The continuous monitoring and verification of status of an entity and analysis of records that
specified requirement and fulfilled
Non- conformity
Non-fulfillment of an intended usage requirements or reasonable expectations, including one
concerned with safety
Management Review
Formal evaluation by top management of the status and adequacy of the quality system in relation
to quality policy and objectives
Validation
Confirmation by examination and provision of objective evidence that specified requirements of a
specific intended use have been fulfilled
Verification
Confirmation by examination and provision of objective evidence that specified requirements have
been fulfilled
Process
Set of interrelated resources and activities, which transforms inputs to outputs.
Procedure
Specified way to perform an activity
Product
Result of activities or processes
Page | 84
Requirements of Society
Obligations resulting from laws, rules codes, statutes or other considerations
Production Permit/Deviation Permit
Written authorization to depart from the originally specified requirements for a product prior
production
Quality Manual
Document stating the quality policy and describing the quality system of an organization
Record
Document which furnishes objective evidence of activities performed or results achieved
Total Quality Management
Management approach of an organization centered on quality based on participation of all its
members of the organization and to society
Quality Improvements
Action taken throughout the organization to increase the effectiveness and efficiency of activities
and processes in order to provide added benefits to both organization and its customers
ISO 9000 STANDARDS AND ITS CLAUSES
Principles of ISO 9000
ISO 9000 sets forth basic elements of a Quality System within the organization
PLAN- the means by which quality- the user- customer defines it is achieved
COMMUNICATE- the procedure to everyone in the organization whose work affects quality
PURCHASING STANDARDS
DOCUMENTATION
QA MANUAL
PROCEDURES
AUDIT SYSTEM
Page | 86
TQM - DEFINITION
TQM is an integrated organizational approach in delighting customers (both external and internal)
by meeting their expectations on a continuous basis through every one involved within the
organization working on a continuous improvement in all products, services and processes along
with problem solving methodology
ELEMENTS OF TQM:
PEOPLE
APPROPIATE TECHNOLOGY
CONTINUOUS IMPROVEMENT
TQM Total Quality Management and TQS Total quality service are two sides of the same coin.
TQM and TQS are inseparable
Each and every employee, each and every department has a role to play.
Page | 87
Organization becomes most effective when all employees and all departments work together
and harmoniously towards common company objectives
Company hires the total man with body, mind and intellect, and not just hands
PEOPLE ORIENTATION
Individual
Team
Managing
Delegation
Participation, Consensus
Control
Empowerment
Problem Management
Problem solving
Flattened Structure
Team Building
Page | 88
Most Timely
Lowest Cost
Transformation
Continuous Improvement
KAI-ZEN: CHANGE
Is a human process
One perceives the deficiency, tries to find a way around it, eventually changes
One cannot change any human system unless he/she is prepared to change himself/herself
KAI-ZEN
Improvement
A continuous improvement
CHANGING ENVIRONMENT
Customer Expectations
People
Product Design
Competition
Product Quality
1. HIGH QUALITY
(Q)
2. REASONABLE PRICE
(P)
3. ON-LINE DELIVERY
(D)
1. PRODUCTIVITY
(P)
2. QUALITY
(Q)
3. COST
(C)
4. DELIVERY
(D)
5. SAFETY
(S)
6. MORALE
(M)
AREAS OF KAIZEN
Cost
Safety
Inadequacy
Present Conditions
Waste
Inconsistency
Page | 90