The document defines key concepts in quality assurance, quality control, and good manufacturing practices (GMP) for pharmaceuticals. It discusses that quality assurance is a process-oriented approach to ensuring quality, while quality control is a product-oriented approach focused on identifying defects. GMP involves all aspects of pharmaceutical production to minimize risks and ensure quality, safety, and efficacy. It outlines responsibilities for quality control, production, and procedures to verify that medicines meet specifications from raw materials to patient use.

1. Definitions, concept of QC, QA and GMP
Quality Assurance and Quality
Management Concepts
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2. 2
2. Procedures to verify that shipped goods meet
specifications:
 Pre and post shipment inspection
 Analytical Pharmaceutical testing
3. Procedures to monitor & maintain the quality of
pharmaceuticals from the moment they are
received until the medicine is finally consumed by
the patient.:
 Proper storage & distribution procedures
 Appropriate dispensing
 Instructions to the patient on proper use of
medication
 Product defect and pharmacovigilance reporting

3. :
3
Quality Control
• ISO 9000 defines quality control as "A part of quality
management focused on fulfilling quality requirements".
• It is that 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.
Process concerned with medicine sampling, specifications,
and testing, and with the organization’s release procedures
that ensure that the necessary tests are carried out and that
the materials are not released for use, nor products released
for sale or supply, until their quality has been judged
satisfactory

4. 4
Responsibili
ties of QC
Day to day
quality
control
Analytical testing
of raw materials,
packaging,
labeling material
Conduct inprocess
testing, env.
Monitoring, inspect
operations
To Conduct
required tests
on finished
Dosage form
Selection of
qualified vendors
for raw material
by testing
representative
samples
Inspection
&Testing of
environmental
area for
manufacturing of
dosage forms

5. 5
Resp.
of QC
Head
Approve/re
ject
starting
/packaging
/intermedi
ate/bulk/fin
ished
products
Evaluate
batch
records
Approve
specs.
Sampling
instructs., test
methods, QC
procedures
Required
initial &
continuing
training to
dept.
personnel
Appropriate
validations
done
Check
maint. Of
dept/premi
ses/equip
ment
Approve &
monitor
contract
analysis

6. 6
Responsibilities
of Production
Head
To ensure
Production &
storage as per
doc.
Approve
instructions for
prod.
Operation for
implementation
Ensures
Validations are
done
To ensure
required
trainings to
dept. personnel
Production
records
evaluated &
signed by
authorized
person
Checks
maintenance of
his dept.,
premises,
equipment

7. Common responsibilities of Production and QC Head
7
Authorization of written procedures/documents/including
amendments
Monitoring & control of Manufacturing environment
Plant Hygiene/Process Validation/Training
Approval & monitoring of suppliers of material/contract
manufacturer
Designing & monitoring of storage conditions for materials &
products
Retention of Records/ Monitoring of compliance with GMP
Inspection, investigation, taking samples to monitor factors
affecting product quality

8. QUALITY ASSURANCE QUALITY CONTROL
process oriented product oriented
set of activities for ensuring quality in
the processes by which products are
developed
set of activities for ensuring quality
in the
Products. activities focus on
identifying defects in the actual
products produced.
managerial tool corrective tool
aims to prevent defects with a focus
on the process used to make the
product
Aims to identify and correct defects
in the finished products
Goal is to improve development and
test processes so that defects do not
arise when the product is being
developed
to identify defects after a product is
developed and before it’s released
Aims to prevent the defect aim is to identify and improve the
defects
technique of managing the quality. method to verify the quality
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9. 9
QUALITY ASSURANCE QUALITY CONTROL
All team members are responsible Testing team is responsible
e.g. Verification e.g. Validation
Means Planning for doing a process Action for executing the planned
process
Statistical technique used :
Statistical Process Control
Statistical Quality Control
makes sure you are doing the right
things
makes sure the results of what
you’ve done are what you expected
Defines standards and
methodologies to followed in order
to meet the customer requirements
ensures that the standards are
followed while
working on the product
process to create the deliverables process to verify that deliverables
responsible for full software
development life Cycle
responsible for software testing life
cycle

10. GOOD MANUFACTURING PRACTICE
10
 Good Manufacturing Practice is a part of quality
assurance which ensure that the products are
consistently produced and controlled according to
quality standards appropriate to their intended use.
 GMP – A set of principles and procedures which,
when followed by manufacturers for the therapeutic
goods, helps /ensure that the products
manufactured will have the required quality
 It is designed to minimize the risks involved in any
pharmaceutical production that cannot be eliminated
through testing the final product.
 Concept born in USA, established in 1963

11. GMP involves
11
 All aspects of production; from the starting
materials, premises and equipment to the
training and personal hygiene of staff.
 Detailed, written procedures are essential for
each process that could affect the quality of the
finished product.
 There must be systems to provide documents
proof that correct procedures are consistently
followed at each step in the manufacturing
process every time a product is made.

12. WHO GOOD MANUFACTURING PRACTICES FOR
PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES
12
 GMP is that part of quality management which
ensures that products are consistently produced
and controlled according to the quality standards
appropriate to their intended use and as required
by the marketing authorization, clinical trial
authorization or product specification.
 GMP is concerned with both production and QC.
GMP is aimed primarily at managing and
minimizing the risks inherent in pharmaceutical
manufacture to ensure the quality, safety and
efficacy of products.

13. UNDER GMP
13
a)All manufacturing processes are clearly defined, systematically
reviewed for associated risks in the light of scientific knowledge
and experience, and shown to be capable of consistently
manufacturing pharmaceutical products of the required quality that
comply with their specifications;
b) Qualification and validation are performed;
c) All necessary resources are provided, including:
 sufficient and appropriately qualified and trained personnel,
 adequate premises and space,
 suitable equipment and services,
 appropriate materials, containers and labels,
 approved procedures and instructions,
 suitable storage and transport,
 adequate personnel, laboratories and equipment for inprocess
controls

14. 14
d) Instructions and procedures are written in clear and
unambiguous language, specifically applicable to the
facilities provided;
e) Procedures are carried out correctly and personnel
are trained to do so;
f) Records are made (manually and/or by recording
instruments) during manufacture to show that all the
steps required by the defined procedures and
instructions have in fact been taken and that the
quantity and quality of the product are as expected.
Any significant deviations are fully recorded and
investigated with the objective of determining the root
cause and appropriate corrective and preventive action
is implemented;

15. 15
g) Records covering manufacture and distribution,
which enable the complete history of a batch to
be traced, are retained in a comprehensible and
accessible form;
h) The proper storage and distribution of the
products minimizes any risk to their quality and
takes account of good distribution practices
(GDP);
i) A system is available to recall any batch of
product from sale or supply;
j) Complaints about marketed products are
examined, the causes of quality defects
investigated and appropriate measures taken in
respect of the defective products to prevent

16. LISTS OF IMPORTANT DOCUMENTS IN
GMP
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 Policies
 Standard operating procedures SOP
 Specifications
 Master formula records MFR
 Batch manufacturing record BMR
 Manuals
 Master plans/Files
 Validation protocols
 Forms and formats
 Records

17. GMP Covers
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Personnel:
Adequate no., qualified, recording of responsibilities assigned,
awareness on principles of GMP
To receive continuing training, including hygiene instructions
Organization chart, people with specific duties with job written
Key personnel includes
Head of production, head of QC, head of engg., QA head
Full time with production head and QC head independent
 In India: GMP inspections done by FDA & CDSCO (central
drug standard control organization)
 In Nepal & more than 100 countries: WHO version of GMP
 In India D&C act 1945 ammnended on 24 June 1988 & GMP
under sch.M.
 Sch. M – 2 parts--- Part 1 & Part 2, GMP is under part 1

18. 18
Objectives of
GMP
To
eliminate
errors
To produce
product of
consistent
quality
To produce
products
confirming to the
predetermined
specific objectives
To minimize
contaminatio
n

19. 19
GMP components
• 1. QM Quality Management
• 2. QA
• 3. GMP for Medicinal products
• 4. QC
• 5. Sanitation & hygiene
• 6. Qualification & validation
•7. Complaints & Recall
•8. Contract production & Analysis
•9. Self inspection, quality audits & suppliers
audits and approval
• 10. Personnel, training & personnel
hygiene
• 11. Premises
• 12. Equipment Premises
• 13. Materials
• 14. Documentation
• 15. Holding & Distribution

20. 20
Design &
construct
facilities &
equipments
Follow written
procedures &
instructions
Document work
Validate work
Monitor facilities
& work
Write step by
step Operating
procedures &
work instructions
Design, develop
& demonstrate
job competence
Protect against
contamination
Control
components &
poduct related
process
Conduct planned
& periodic audits
PRINCIPLES OF GMP

21. 21
SALE
Packaging
material
testing
Premises
Finished
product testing
Equipments
Quality control
department
Personel Records
Sanitation
Samples Raw material
testing
Stability
Manufacturing
control
Sterile
products
CATEGORIES OF GMP

22. Personnel training
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 Training to Technical, Maintenance, Cleaning personnel
–Quality
 Continuing training & assessment of practical
effectiveness
 Approved Training programs by Production head/QC
head
 Maintain records of training
 Specific training to personnel in areas of high
hazards/toxic/ infectious/sensitizing materials
 Visitors/untrained persons – not allowed in
production/QC area
 Should be informed in advance about personal
hygiene/protective clothing etc.

23. Personnel hygiene
23
 Establishment & adaptation of detailed hygiene
programs related to health, hygiene/clothing of
personnel
 Receive medical examination on recruitment
 Not to engage persons with infectious disease/open
lesions
 Should wear protective garments for specific
operations
 Eating, drinking, chewing, smoking, storage of food,
drink, smoking materials/medication in production &
storage area – prohibited
 Avoiding direct contact of operators hand and
exposed product/equipment

24. Building & facilities
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 Design & construction features
 Building of suitable size, location, cleaning maintenance,
proper operations
 Adequate space for equipments- prevent mix-ups, drug
product containers, closures, labeling, in process materials,
drug products
 Movement of components & product in building must be
designed to prevent contamination
 Specific operations must be performed in specific areas
 Floors. Walls, ceilings- smooth
 Temp. & Humidity control
 Air supply through HEPA filters under positive pressures
 Heating, Ventilation & air conditioning (HVAC)
 Sewage, trash, refuse in & from the building- safe & sanitary
manner
 Adequate washing facilities- hot cold water, soap, air driers,
towels etc.
 Free from rodents, birds, insects, vermin, trash, organic

25. Equipments
25
 Appropriate design, size, location, cleaning,
maintenance
 Surfaces in contact with components, in process
materials, drugs, should not be reactive- to alter
safety, identity, strength, quality
 Cleaning and maintenance, sanitization at intervals
 Written procedures for cleaning etc.
 Assigning responsibility for cleaning
 Cleaning schedules
 Describing methods, equipments, materials used in
cleaning, methods to dissemble and re assemble
 Removal of previous batch identification
 Protection of clean equipment
 Inspection for cleanliness before use

26. SANITATION & HYGIENE
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 Covers personnel, premises, equipments, apparatus,
production materials, containers, products for cleaning
& disinfection etc.
 Layout & design of premises to minimize the risk of
errors, permit effective cleaning, maintenance to avoid
cross contamination, build up of duct, dirt which may
effect the quality
 Dust if generated during various processes sampling,
weighing, mixing & processing operations, packaging
etc. Avoid cross contamination, facilitate cleaning.
 Personnel should be instructed to wash hands before
entering the production areas, sign boards,
instructions