Assurance
B
Introduction
• GMP ensures that quality is built into the
organization & processes involved in
manufacture
• GMP covers all aspects of manufacture
including collection, transportation,
processing, storage, QC & delivery of the
finished product
GMP
• Part of QA which
ensures that products
are consistently
produced & controlled
to the quality
standards appropriate
to their use.
• GMP is an integral part
of QA.
QA, GMP & QC inter-
relationship
QA
It is the sum total of the organized
arrangements with the objective of
ensuring that products will be of the
quality required for their intended use
QA, GMP & QC inter-
relationship
GMP
Is that part of QA aimed at ensuring
that products are consistently
manufactured to a quality
appropriate to their intended use
QA, GMP & QC inter-
relationship
QC
Part of GMP concerned with
sampling, specification &
testing, documentation &
release procedures which
ensure that the necessary
& relevant tests are
performed & the product
is released for use only
after ascertaining it’s
quality
QC & QA
• Part of GMP which is • QA is the sum total of
concerned with organized
sampling, arrangements made
specifications, with the object of
testing and with in the ensuring that product
organization, will be of the Quality
documentation and required by their
release procedures intended use.
which ensure that the
necessary & relevant
tests are carried out
QC & QA
• Operational • All those planned
laboratory or systematic
techniques & actions necessary
activities used to to provide
fulfill the adequate
requirement of confidence that a
Quality product will satisfy
the requirements
for quality
QC & QA
QC is laboratory QA is company
based based
GMP
• GMP in solid dosage forms
• GMP in semisolid dosage forms
• GMP in Liquid orals
• GMP in Parenterals Production
• GMP in Ayurvedic medicines
• GMP in Biotechnological products
• GMP in Nutraceuticals & cosmeceuticals
• GMP in Homeopathic medicines
GMP
• Good Manufacturing Practice
• Good Management Practice
• Get More Profit
• Give more Production
• GMP Training with out tears
Ten Principles of GMP
1. Design & construct the facilities & equipments
properly
2. Follow written procedures & Instructions
3. Document work
4. Validate work
5. Monitor facilities & equipment
6. Write step by step operating procedures & work on
instructions
7. Design, develop & demonstrate job competence
8. Protect against contamination
9. Control components & product related processes
10. Conduct planned & periodic audits
Beyond GMP
• Reduce pollution - Zero discharge
• Adaptation of environment friendly
methods
• Consideration for better & healthier life
tomorrow
• Consideration of ethics in life
• One should begin with end in mind
otherwise it will be the beginning of the
end
Cost of effective GMP
• In fact Cost benefits – positive cost benefits of
GMP/QA
• Good plant lay out, Smooth work flows, Efficient
documentation systems, well controlled process,
good stores lay outs and stores records- These
are Good manufacturing practices
• Reduction in work in process & inventory holding
costs
• Avoidance of cost of Quality failure ( cost of
waste, of rework, of recall, of consumer
compensation and of loss of company reputation)
List of important documents in
GMP
• Policies
• SOP
• Specifications
• MFR (Master Formula Record)
• BMR
• Manuals
• Master plans/ files
• Validation protocols
• Forms & Formats
• Records
How do GMPs of different
countries compare?
GMP
Quality Assurance
QC
G.M.P.
Quality Control
What is Quality Management?
The aspect of management function that
determines & implements the “quality policy”
Items concerned :
Starting materials
Packaging materials
Bulk products
Intermediate and finished products
Environmental conditions
BASIC REQUIREMENTS OF
QUALITY CONTROL (1)
Establish QC procedures
Manage reference standards
Ensure correct labeling
Stability testing (if applicable)
Complaint investigation
Environmental monitoring
QUALITY CONTROL
ACTIVITIES
Establish QC procedures
Manage reference standards
Ensure correct labeling
Stability testing (if applicable)
Complaint investigation
Environmental monitoring
PERSONNEL
• Adequate staff with relevant knowledge,
experience and capabilities in assigned task
a. Production and QC are headed by
different persons, neither of whom shall
be responsible to the other
b. Responsibilities and authority of key
personnel are clearly defined
c. Training on the understanding of
procedures, work instruction, GMP
principles , etc.
Personnel Qualifications
• “Each person engaged in the manufacture,
processing, packing, or holding of a drug
product shall have education, training, and
experience, or any combination thereof, to
enable that person to perform the
assigned functions. Training shall be ...”
• There are competent and appropriately qualified
personnel in sufficient numbers to ensure service
provision.
The responsibilities of all staff should be
clearly understood and recorded.
All personnel receive initial and continuing
training relevant to their needs.
Only staff who have appropriate training are
authorised to carry out that procedure.
Training should be structured and continuous.
Training records based on SOPs are a good means
of evidencing that staff are able to perform
tasks.
Competency Assessments can also be used to
assess procedural training.
3 Key Personnel
• The head of production
• The head of QC
• The head of QM (QA)
The head of production
• The head of production should be a
qualified pharmacist, adequately trained,
possess good practical experience in
pharmaceutical manufacture & managerial
skill.
• The head of production should have full
authority & responsibility to manage
production of pharmaceutical products.
The head of QC
• The head of QC should be a qualified
pharmacist, have adequate training &
practical experiences which enable
him/her to perform him/her function
personally.
• The head of QC should given full authority
& responsibility in all QC duties.
The head of QM (QA)
• The head of QM (QA) should be a
qualified pharmacist, have adequate
training & practical experiences which
enable him/her to perform him/her
function personally.
• The head of QM (QA) should given full
authority & responsibility in all quality
system/assurance duties.
PREMISES
Specify the requirements of location, design ,
constructions and maintenance of manufacturing
premises with respect to the following:
a. prevention of contamination from surrounding
environment and pests
b. prevention of mix up of materials and products
c. facilities such as toilet, changing rooms, sampling
areas and QC lab
d. defined areas for certain activities
e. wall, ceiling, drains , air intake and exhaust,
lighting and ventilation, pipe work and light
fitting
f. storage areas
• Suitable location, design , constructions and
maintenance for manufacturing premises :
– defined areas for certain activities (e.g
material sampling & dispensing)
– wall, ceiling, drains , air intake and exhaust,
lighting and ventilation, pipe work and light
fitting
– storage areas of adequate space
– Physical separation of toilets and QC lab
from production
Building & facilities
1. Design and construction features.
2. Lighting.
3. Ventilation, air filtration, air heating and
cooling.
4. Plumbing.
5. Sewage and refuse.
6. Washing and toilet facilities.
7. Sanitation.
8. Maintenance.
Paint Finish…
• Not only building
paintwork must be
considered but also
equipment
Building Finishes:
• In module 1 we discussed the need for all
facility components to complement each
other.
• Therefore a good air handling system
must be complemented by a building of
good design and good finishes.
• On the next slide we will be looking at
some of the Acceptable and Un-acceptable
building finishes.
Building Finishes
Not Acceptable Acceptable
PVA Paint Epoxy or Enamel
paint
Window sills Flush glazed windows
Exposed pipes Smooth surfaces
Horizontal pipes & Concealed services
services
Open floor drains Hygienic drains
Floor cracks, flaking Homogonous sealed
floor surfaces floors – epoxy finish
or welded vinyl
Ceiling cracks & Smooth sealed
joints ceilings
Exposed, open light Flush light fittings
fittings
Wooden furniture S/Steel or Melamine
furniture
Floors / drains
Design and Construction
Features
“Any building or buildings
used in the manufacture,
processing, packing, or
holding of a drug product
shall be of suitable size,
construction, and location
to facilitate cleaning,
maintenance, and proper
operation.”
Product Areas
• Premises should preferably
be laid out in such a way as:
– To allow the production to take
place in areas connected in a
logical order corresponding to
the sequence of the
operations, the requisite
cleanliness levels,
– To avoid crowding and disorder,
– To allow effective
communication and supervision.
Weighing Area
• The weighing of starting materials and the
estimation of yield by weighing should be
carried out in separate weighing areas
specially designed for that use. Such areas
may be part of either storage or
production areas.
Storage Areas