1. What is validation? What is the importance of validation in pharmaceutical industry?

Validation is a documented evidence which provides a high degree of assurance that a specific process, method or
system will consistently produce to the required specification in accordance with accepted standards of cGMP.
Importance of Validation :
a) In pharmaceutical industry the validation is required for national or international regulations
b) Validation is a part of integrated requirements of a quality system
c) Validation meets the consistency of quality product in all stages

2. What do you mean by Prospective, Retrospective and Concurrent validation?

Prospective : A prospective process validation states that three consecutive marketed batches are manufactured &
tested as per prospective process validation SOP. Validation data has generated by validation committee. When all data
are fully satisfied then this product are released for sale & called this process is validated to use routinely in
production.

Retrospective : A retrospective process validation are performed by documenting all the historical information of
existing 10 products using trend analysis data in QCMS system & its ensures that the existing process is under control.

Concurrent validation : Concurrent validation is carried out during routine production. This method is effective only if
the development stages have resulted in a proper understanding of the fundamental of the process. Some manufacture
refers the concurrent validation as Prospective process validation.


3. Write the basic requirements of cGMP/GLP?
Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced
and controlled to the quality standards appropriate to their intended use and as required by the Marketing
Authorization or product specification.
Good Manufacturing Practice is concerned with both production and quality control. The basic requirements of GMP
are that -
a. appropriately qualified and trained personnel;
b. adequate premises and space;
c. suitable equipment and services;
d. correct materials, containers and labels;
e. approved procedures and instructions;
f. suitable storage and transport;

4. What do you mean by DQ, IQ, OQ, & PQ ?
Design Qualification (DQ): documented verification that the proposed design of the facilities, equipment, or systems is
suitable for the intended purpose.

Installation Qualification (IQ): documented verification that the equipment or systems are installed or modified &
comply with the approved design of the manufacturers recommendations and/or user requirements.

Operational Qualification (OQ): documented verification that the equipment or systems are installed or modified &
perform as intended throughout the anticipated operating ranges.

Performance Qualification (PQ): documented verification that the equipment and ancillary systems are connected &
can perform effectively and reproducibly based on the approved process method and specifications.





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5. Define complaint & recall.
All quality related complaints of a product from the market should be recorded & investigated accordingly to a
written procedure.

Recall is the removal from the market of specified batches or all batches of a product. A recall situation can result from
information entering a company in various ways:
Customer complaints these may be so serious as to initiate a recall. An example could be the
evidence of a lack of sterility
GMP deviations/results of a failure investigation
The result from the QC stability programme
Request by the regulatory authorities
Result of an inspection
Known counterfeiting or tampering
Adverse drug reaction (ADR) reported, leading to a recall decision (however, an ADR does not
automatically lead to a recall).

6. Define Corrective Action & Preventive Action ?
Preventive Action : In order to prevent occurrence the potential action has to be taken from non conformity,
defect or other undesirable situation.
Corrective Action : Action has to be taken to eliminate the detected non conformity or other undesirable
situation.


7. What is In Process Control ? Why it is important ?

To ensure the product conformation of its specification, checking & monitoring are performed during
production. The controlled of the environment or equipment may also be regarded as part of in process controlled.

Importance : It is important to adjust the process to assure that the product confirms to it final specification.

8. What is Sanitation & House keeping?

Sanitation : It is the hygienic control on manufacturing process including personnel, premises, equipment & material
handling.
Housekeeping is the practice of keeping the workplace clean, tidy & free of potential hazards. Correct housekeeping is
practised before, during & after the task is completed.

9. What is self inspection?

Self inspections should be conducted in order to monitor the implementation and compliance with Good
Manufacturing Practice principles and to propose necessary corrective measures.

10. Define Stating Materials, Intermediate , Bulk & Finished Products :
Stating Materials : A starting material is known as raw material or an API. A substance is a defined quality which used
in production of a pharmaceutical product & non-pharmaceutical product excluding packaging material.

Intermediate : A partly processed material that must undergo the further manufacturing steps before a bulk product.

Bulk Product : Any product that has completed all processing steps up to but not including final packaging.

Finished Products : A medicinal product, which has undergone all stages of manufacture including packaging.

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11. What is sampling? What standards are used for sampling?
Sampling should be conducted according to written procedures. Sampling Process are obtain from finished
material, in-process material, raw material or components for assessment with a view to determining the properties of
the universe from which they were drawn.
Sampling plan -
Specific design indicating number from each lot or batch are inspected & determined the acceptability the lot or batch.
Military Standard 105E is frequently used for determining statistical sample size.

12. Write the differences between documents & records.

Documents : Documentation is a controlled written procedure, policy, forms or other pieces of paper as defines a
company requirement. & describe how what to do.

Records : When data or results providing evidence of activities performed then it is record.

13. When and where revalidation is required ?
Revalidation means that the original validation program should be repeated at a predetermined frequency. This work is
carried out 3 years interval & any change of critical steps or process.
i. Changes in raw materials (Physical parameters such as viscosity, density, moisture & Particle size distribution)
may affect the products & process
ii. Changes in the sources of active raw materials manufacturer
iii. Changes in the packaging materials (Primary packaging/Closure system)
iv. Changes in the processes (e.g. mixing time, dry time, drying temp.& batch size)
v. Changes in the equipment (e.g. addition of automatic electric system)
vi. Changes in the plant or facility
vii. Variation revealed by trend analysis.

14. What are critical, major and minor defects of a product ?
Critical defect : Critical defect are those defect which can be life-threating & which require the company to take
immediate action by all responsible means as soon as the defect becomes apart whether in or out of business hours.
Example : 1. Products labeled with incorrect name.
2. Counterfeit or deliberately tampered with product/
3. Microbiological contamination of a sterile product

Major defect : Major defect are those defects which may put the patient at some risk but. Which are not life-threating
Example : 1. Any labeling/leaflet misinformation which represents a significant hazard to the patient
2. Microbial contamination of non-sterile product with some risks.

Minor defect : Minor defect are those defects which present only a minor risk to the patient. Any batch recall or
product withdrawal would normally be initiated a few days.
Example : 1. Readily visible isolated packing faults
2. Contamination which may cause spoilage or dirt & where there is minimal risk to the patient

15. What is sterilization? Mention the duration sterility test.
Sterilization is a process or technique to remove bacteria and all types of viable microorganism.
Duration : 14 days



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16. Write the types of Sterilization.
Type of Sterilization:
Terminal Sterilization
1) Steam Heat sterilization
2) Dry Heat sterilization
Others sterilization
3) Gas sterilization
4) Sterilization by ionizing Radiation
5) Sterilizing by Filtration
6) Aseptic Processing

17. Write the functions & use of HVAC system.
Functions and use of HVAC

Heating, Ventilating and Air conditioning system is used for temperature and humidity control with in a manufacturing
environment. It includes air handling units, air distribution network, air-cooling and heating system, air filtration,
equipment control system, monitoring and alarm decreases

18. What is SOP? Why it is needed ?
SOP (Standard Operating Procedure)
A written approved procedure which gives instruction for performing operation not necessarily specific to a given
product or material but of a more general matter (e.g. equipment operation, maintenance and cleaning of premises, and
environmental and sampling and inspection).
Purposes: To describe the method for writing procedures for all general operations.

19. What do you mean by critical processing steps ?
Describes a process steps, process condition, test requirement or other relevant parameter or items that must be
controlled within predetermined criteria to ensure that the API meets its specification.

20. Write the conditions of sterilization by Autoclave & DHS.
Condition of sterilization by Autoclave & DHS

121
0
C 15 lbs pressure per square inch 15 minutes
200
o
C for 1 Hour.

21. What are the points to be checked during validation of DHS/ Autoclave?
Points to be checked during validation of DHS/Autoclave

Checked by biological indicator (Bacillus sublitis) and endotoxin indicator for DHS
Checked by biological indicator (Bacillus stearothermophilus).


21. What is Clean Room & Aseptic Area?
Clean Room

A room in which the concentration of airborne particles is controlled to meet specified airborne particulate cleanliness
class. In addition, the concentration of microorganisms in the environment is monitored; is cleanliness class defined is
also assigned a microbial level for air, surface, and personnel gear.

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Aseptic Area

Any area in an aseptic process system for which airborne particulate and microorganism levels are controlled to
specific levels appropriate to the activities conducted within that environment.


22. What is Air lock?

Airlock: An enclosed space with two or more doors, which is interposed between two or more rooms, e.g. of differing
classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to be entered. An
airlock is designed for use either by people or for goods and/or equipment.

23. What Is Site Master File ?
Site Master File

Site Master File is prepared by the manufacturer and contains specific information about the quality assurance, the
production and/ or quality control of pharmaceuticals manufacturing operations carried out at the named site and any
closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceuticals operation is carried out
on the site. A site master file need only describe those operations that is analysis packaging etc.

24. How to sanitize the Water Supply lines?
Sanitize the water supply lines
Sanitize by Steam flush and Chlorinization.

25. How to clean the Product Manufacturing Vessels?
Wash the vat with portable water. Rubbing the vat & lid with 1% sodium lauryl sulphate & then washing the inner side
& outside with potable water. Washing the vat by hot water & then rinsing the vat with DM water. Rubbing the vat
with 70% IPA.

26. How to clean the Product Manufacturing Vessels?
Vessels wash with Potable Water, then wash with 2% sodium laural sulphate, Hot water, Potable water swab with 70%
IPA, finallay swab by cotton cloth.

27. What are the differences between Sanitization and Sterilization?
Sterilization
Sterilization is a process or technique to remove bacteria and all types of viable microorganism.
Duration: 14 days
Sanitization
Reduction the number of micro-organism to a safe or relatively safe level as determined by applicable, regulations or
the purpose of application

28. What is 1 & 2 Standards?
1 Standard: A substance that has been authentic material should be of high purity.eg. K2Cr2O7,KI.

2 Standard: A substance of established quality and purity by comparison with primary reference standard and used
as a reference standard for routine laboratory analysis.

29. What are the parameters of Analytical Method validation?
Accuracy, Precision, Specificity, Detection Limit, Quantitation Limit, Linearity & Range, Ruggedness & System
suitability Testing.

30. Write short note on gram +Ve & gram Ve bacteria ? which one is more pathogenic ?
Gram +Ve Bacteria

Gram +Ve bacteria are those that are stained dark blue or violate by gram staining. This is contrast to gram Ve .

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Gram Ve Bacteria
Gram Ve bacteria are those bacteria that do not retain crystal violate dye in the gram staining protocol.
Gram Ve bacteria is more pathogenic than gram +Ve.

31. Write Air classification on cleanliness of parentral preparation.
Air Classification on cleanliness of parentral preparation

Grade At Rest In Operation
Maximum permitted particles/ m3 =or above
0.5 5 0.5 5
Grade A 3500 0 3500 0
Grade B 3500 0 350000 2000
Grade C 350000 2000 3500000 20000
Grade D 3500000 20000 Not Defined


32. Mention Moist Heat Sterilization period and temperature.
Moist Heat sterilization

Temperature : 121
0 C
Duration : 15 minutes
Pressure : 15 lbsPressure/Square inch

33. Which type of water are used in sterile preparation.
Water for Injection(Bulk)-
Characters-A clear, colorless, odorless and tasteless liquid.
Nitrates-Not more than 0.2 ppm
Heavy metals-Not more than 0.1 ppm
Conductivity-Conductivity at 20C not more than 1.1 S.cm-1.
Microbial Contamination-Total viable aerobic count should less than 10 micro-organism per 100 ml. Absence of E.
Coli, Salmonella, Staphylococcus aureus & Pseudomonas.
Bacterial endotoxins-Less than 0.25 IU per ml.

34. What is the source of Endotoxin ? Write the source of Microbial Contamination of Product.
Source of Endotoxin

Gram Ve bacterial cell wall.
Source of microbial contamination of a product

Person, Water, Air, RM, Rubber stopper, Glass Vial and Garments

35. Write the full meaning of DOP & HEPA and its efficiency.
DOP : Dioctyl Phthalate .Dioctyl Pthanate test is used to determine the integrity of HEPA filters.

HEPA: High Efficiency Particulate Air .High Efficiency Particular Air Filter (HEPA) is a filtering system. HEPA filter
capable of retaining 99.97 percent of particles as small as 0.3 m. It is a disposable, extended media dry type filter in a
rigid frame.
Efficiency: 99.97%
36. What is QC and QA of a product ?
QA & QC are closely related, but they are different concepts. Quality Assurance Section is the total organization made
with the objective of ensuring that pharmaceutical products are of the quality required for their intended use .QA
therefore incorporates GMP and other factors such as product design and development, GLP and GCP.
Quality control is the process where the product is actually executed and the expected behaviour is veritied by
comparing with the actual behaviour of the software under test. All the testing types like black box testing, white box
testing comes under quality control.
Quality assurance is done before quality control.
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37. What are the basic requirements of premises of pharmaceuticals production Area?
Premises of Manufacturing Area

1. Dedicated facilities
2. Logical flows of materials and people.
3. Adequacy of working space and orderly and logical positioning of equipment.
4. Interior surfaces smooth, crack-free and easy to clean.

38. What are the basic requirements of premises of pharmaceuticals product & RM Storage Area?
Premises of RM store Area
1. Storage areas of sufficient capacity
2. Clean, dry and maintained within acceptable temperature limit
3. QC sampling area with GMP standard
4. Segregated areas for rejected recalled and returned materials
5. Separate areas for highly active hazardous narcotics materials
Premises of Manufacturing Area

1. Dedicated facilities
2. Logical flows of materials and people.
3. Adequacy of working space and orderly and logical positioning of equipment.
4. Interior surfaces smooth, crack-free and easy to clean.

39. What is training ? Why it is needed ?
Training: Training is a tool/way to know something to increase our knowledge or skill.
Importance of training:
Training helps to provide an opportunity and broad structure for the development of human resources technical and
behavioral skills in an organization. It also helps the employees in attaining personal growth.

40. What are the functions of Qualified and key personnel in a Pharmaceutical Industry ?
I. A qualified person must ensure that each batch has been produced & tested/ checked in accordance with the
directives & marketing authorization
II. A qualified Person musr certify in a register or equivalent document as operations are carried out & before
any release that each production batch satisfies under the requirement of GMP

Functions of key personnel in a Pharmaceutical Industry:
I. To ensure that the production records are evaluated and signed be an authorized person before they are sent to
the QC department.
II. To check the maintenance of his department, premises and equipment.
III. To ensure that the appropriate validations are done.
IV. To approve or reject, as sees fit, starting materials, packaging materials. And intermediate, bulk & finished
products.
V. To evaluate batch records.
VI. To ensure that all necessary testing is carried out
VII. To approve specifications, sampling instructions, test methods and Quality Control procedures.
VIII. To approve and monitor any contract analysis.

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