1. GMP & Quality
Assurance
B

2. 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

3. 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.

4. QA, GMP & QC interrelationship
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

5. QA, GMP & QC interrelationship
GMP
Is that part of QA aimed at ensuring
that products are consistently
manufactured to a quality
appropriate to their intended use

6. QA, GMP & QC interrelationship
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

7. QC & QA
• Part of GMP which is
concerned with
sampling,
specifications,
testing and with in the
organization,
documentation and
release procedures
which ensure that the
necessary & relevant
tests are carried out
• QA is the sum total of
organized
arrangements made
with the object of
ensuring that product
will be of the Quality
required by their
intended use.

8. QC & QA
• Operational
laboratory
techniques &
activities used to
fulfill the
requirement of
Quality
• All those planned
or systematic
actions necessary
to provide
adequate
confidence that a
product will satisfy
the requirements
for quality

9. QC & QA
QC is laboratory
based
QA is company
based

10. GMP
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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

11. GMP
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Good Manufacturing Practice
Good Management Practice
Get More Profit
Give more Production
GMP Training with out tears

12. 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

13. 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

14. 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)

15. List of important documents in
GMP
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Policies
SOP
Specifications
MFR (Master Formula Record)
BMR
Manuals
Master plans/ files
Validation protocols
Forms & Formats
Records

16. How do GMPs of different
countries compare?
At a high level, GMPs of various nations are very
similar; most require things like:
 Equipment & facilities being properly
designed, maintained, & cleaned
 SOPs be written & approved
 An independent Quality unit (like QC and/or QA)
 Well trained personnel & management

17. Basic Requirements of
GMP
• All manufacturing processes are clearly defined,
systematically reviewed, & shown to be capable of
consistently manufacturing medicinal products of
the required quality & complying with
specifications.
• Critical steps of the process and significant
changes to the process are validated

18. Why GMP is important
– A poor quality medicine may contain
toxic substances that have been
unintentionally added.
– A medicine that contains little or none
of the claimed ingredient will not have
the intended therapeutic effect.

20. QUALITY
RELATIONSHIP
Quality Management
QA
Quality Assurance
GMP
QC
G.M.P.
Quality Control

21. What is Quality Management?
The aspect of management function that
determines & implements the “quality policy”
The overall intention & direction regarding
quality, as formally expressed & authorized by
top management

22. BASIC PRINCIPLE OF
QUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic
products comply with the requirements of
ASEAN Cosmetic Directives (ACD).
They should also comply with any other
applicable regulations pertaining to your
specific country.
The attainment of this quality objective
should be led by the senior management &
requires the participation and commitment
by staff, by the company’s suppliers and
distributors.

23. BASIC PRINCIPLE OF
QUALITY MANAGEMENT (2)
To achieve the reliable quality objective, there
should be a comprehensive QA system
incorporating GMP.
The QA system should be fully
documented & its effectiveness
should be monitored.

24. QUALITY ASSURANCE
• QA covers all matters which
individually or collectively influence
the quality of a product.
All parts of QA system
should be adequately resourced with:
Competent personnel
Suitable & sufficient premises,
equipment & facilities

25. Principles of Quality
Assurance (QA)
• Wide-ranging concept
Covers all matters that individually or
collectively influence the quality of a product
• Totality of the arrangements
To ensure that the drug is of the right quality
for the intended use
• QA incorporates GMP
and also product design &
development which is outside the
scope of this module

26. BASIC REQUIREMENTS OF
QA
 Ensure that products are designed and developed based on
sound scientific rationale and with GMP or GLP principles
being taken into consideration.
 Ensure that managerial responsibilities are clearly specified.
 Ensure that production and control operations are clearly
specified and GMP is adopted.
 Organize supply & use of correct starting & packaging
materials.
 Ensure that finished products are correctly processed &
checked before release.
 Ensure that products are released after review by authorized
person.
 Provide satisfactory arrangement to ensure products are
stored, distributed & handled appropriately.
 Put in place a mechanism for regular self inspection / internal
quality audit.

27. GOOD MANUFACURING
PRACTICES
 Part of QA which ensures that products are
consistently produced and controlled to the quality
standards appropriate to their intended use.
 Minimize risks :
• cross contamination




• mix up
Ensure products/materials are traceable to the
original source.
Product testing is not reliable way to assure product
quality. Should BUILD quality into the product!
Production and quality control functions should be
independent of each other.
All manufacturing process are clearly defined and
systematically reviewed.

28. All necessary facilities/resources for
GMP should be provided :
adequate, qualified and well-trained
personnel
suitable premises and sufficient space
suitable location
good personal hygiene and proper
sanitation
suitable equipment and services

29. QUALITY CONTROL
QC is part of GMP.
QC is concerned with sampling, specification and testing.
Manufacturer should have a QC department.
QC should be headed by an appropriately qualified and
experienced person.
QC should be independent from production and other
departments.
Ensure that the necessary and relevant tests are actually
carried out.
Ensure that no materials or products will be released for
sale or supply, until their quality have been evaluated and
judged to be satisfactory.

30. SCOPE OF QC
Items concerned :
Starting materials
Packaging materials
Bulk products
Intermediate and finished products
Environmental conditions

31. BASIC REQUIREMENTS OF
QUALITY CONTROL (1)
Adequate facilities, trained personnel and approved
procedures should be available for sampling,
inspecting and testing and, where appropriate,
environment monitoring.
Sampling by QC personnel & testing by approved
methods.
Approved test methods.
Maintenance of QC records &
failure investigation records.

32. BASIC REQUIREMENTS OF
QUALITY CONTROL (2)
 Ingredients comply with regulatory specification (grade,
composition, strength)
 Review and evaluation of production documentation
 Assessment of process deviations
 Release of batches by authorised person
 Sufficient reference samples of starting materials and
finished products

33. OTHER DUTIES OF QC
Establish QC procedures
Manage reference standards
Ensure correct labeling
Stability testing (if applicable)
Complaint investigation
Environmental monitoring

34. QUALITY CONTROL
ACTIVITIES
QC
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
should cover the following:
Sampling
Specification
Testing
Release procedures
Recalls and complaints
Decision making in all quality matters
Definition of product quality
Laboratory operations
Release authorisation
Investigation and reporting

35. BASIC REQUIREMENTS OF
QUALITY CONTROL
 Adequate facilities, trained personnel and approved
procedures should be available for sampling, inspecting
and testing and, where appropriate, environment
monitoring.
 Sampling by QC personnel & testing by approved
methods.
 Approved test methods.
 Maintenance of QC records & failure investigation
records.
 Ingredients comply with regulatory specification
(grade, composition, strength)
 Review and evaluation of production documentation
 Assessment of process deviations
 Release of batches by authorised person
 Sufficient reference samples of starting materials and
finished products

36. OTHER DUTIES OF QC
Establish QC procedures
Manage reference standards
Ensure correct labeling
Stability testing (if applicable)
Complaint investigation
Environmental monitoring

38. 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.

39. 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 ...”

40. • 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.

41. 3 Key Personnel
• The head of production
• The head of QC
• The head of QM (QA)

42. 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.

43. 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.

44. 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.

46. 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

47. • 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

48. Building & facilities
1.
2.
3.
4.
5.
6.
7.
8.
Design and construction features.
Lighting.
Ventilation, air filtration, air heating and
cooling.
Plumbing.
Sewage and refuse.
Washing and toilet facilities.
Sanitation.
Maintenance.

49. Paint Finish…
• Not only building
paintwork must be
considered but also
equipment

50. 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.

51. Building Finishes
Not Acceptable
Acceptable
PVA Paint

Window sills

Epoxy or Enamel
paint
Flush glazed windows
Exposed pipes

Smooth surfaces
Horizontal pipes &
services
Open floor drains

Concealed services




Hygienic drains

Floor cracks, flaking 
floor surfaces
Homogonous sealed
floors – epoxy finish
or welded vinyl
Smooth sealed
ceilings


Ceiling cracks &
joints
Exposed, open light
fittings


Flush light fittings

Wooden furniture

S/Steel or Melamine
furniture



52. Floors / drains

53. 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.”

54. 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.

55. 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.

56. Storage Areas
Specify the requirements concerning storage of
materials/ products with respect to the
following
a.
b.
c.
d.
e.
f.
g.
h.
Space, design, security and cleanliness
Storage of quarantine stocks
Storage of hazardous substances
Conditions of storage area
(e.g. temperature & relative humidity)
Receiving of incoming materials
Stock control (e.g. FIFO principle,
proper
labeling on the container)

57. Ventilation, Air Filtration, Air
Heating and Cooling
“Equipment for adequate control over air
pressure, micro-organisms, dust, humidity,
and temperature shall be provided when
appropriate for the manufacture,
processing, packing, or holding of a drug
product.”
“Air-handling systems for ... penicillin shall
be completely separate from those for
other drug products for human use.”

58. Poor & Good Windows

59. QC Areas
• QC laboratories should be
designed to suit the operations
to be carried out in them.
• QC laboratories should be
separated from production
areas.
• Areas where biological or
radioisotope test methods are
employed should be separated
from each other.

60. Ancillary Areas
• Rest and refreshment rooms should be
separated from production & QC
laboratory areas.
• Facilities for changing clothes and for
washing and toilet purposes should be
easily accessible & appropriate for the
number of users.

61. Thank you
for
Your Kind
Attention