industrial pharmacy

2. CURRENT GOOD
MANUFACTURING PRACTICES
(cGMP)

3. Definitions
 GMP, is a set of guidelines and regulations that are designed to
ensure that products are consistently produced and controlled
to meet quality standards appropriate for their intended use and
as required by regulatory agencies.
 It covers all aspects of the manufacturing process(MP),
including the facilities, equipment, personnel, and procedures
used to produce a product.
 The primary goal of GMP is to prevent errors, contamination, and
mix-ups in the MP that could lead to unsafe or ineffective products.
 GMP regulations provide a framework for manufacturers to follow
that helps to ensure that their products are safe, effective, and of high
quality.
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4. GMP….
 GMP handbooks for every
industry.
 It is concerned with both
Production and Quality
Control .
 It’s a magic key that opens the
door to quality.

5. GMP….
 A basic tenet (principle) of GMP is that quality cannot
be tested into a batch of product but must be built
into each batch of product during all stages of
the manufacturing process.
 It is designed to minimize the risks involved in
any pharmaceutical production that cannot be
eliminated through testing the final product.

6. Quality Control:
Quality control can be defined as a set of activities and techniques used to
fulfill quality requirements and ensure that products or services meet
predetermined standards.
It is that part of GMP concerned with sampling, specification &
testing, documentation & release procedures which ensure that the
released
necessary & relevant tests are performed
for use only after ascertaining it’s quality.
& the product is
Difference between QAand QC
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Definition
QAis a set of activities for ensuring
quality in the processes by which
products are developed.
QC is a set of activities for ensuring
quality in products.
QAis a managerial tool QC is a corrective tool

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What are its goals and on what does it focus?
QA aims to prevent defects with
a focus on the process used to
make the product. It is
a proactive quality process.
QC aims to identify (and correct)
defects in the finished product.
Quality control,
therefore, is a reactive process.
The goal of QA is to improve
development and test processes
so that defects do not arise when
the product is being developed.
The goal of QC is to identify
defects after a product is
developed and before it's
released.
Everyone on the team involved in
developing the product is
responsible for quality assurance.
Quality control is usually the
responsibility of a specific team
that tests the product for defects.

8. What is Quality Management?
The aspect of management function that determines and implements
the “quality policy”
The overall intention and direction regarding quality, as formally
expressed and authorized by top management
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Principles of QualityAssurance (QA)
Quality assurance is a management tool
Wide-ranging concept covers all matters that individually or
collectively influence the quality of a product
QualityAssurance incorporates GMP
QA System should ensure:
 Products are designed and developed correctly
 Complying with, e.g. CGMP
, GCP
, GLP
 Production and control operations are defined
 Managerial responsibilities are defined

9. 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
GMP: Is that part of Quality Assurance aimed at ensuring that
products are consistently
their intended use
manufactured to a quality appropriate to
QC: Is that part of GMP
testing, documentation &
concerned with sampling, specification &
release procedures which ensure that the
necessary & relevant tests are performed & the product is released
for use only after ascertaining it’s quality
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10. Components of GMP
1. Premises
Principle
Important aspects to be kept in mind to ensure the suitability of the
operations to be carried
range:
Location
Design
Construction
Adaptation
Maintenance
(a) Location
out for different dosage forms and product
Geography, climate, noise and economic factors Neighbors
What impact can they have on the business?
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11. Pollution/effluent control
Minimum risk for contamination of products and materials
Principle
Premises must be located to minimize risks of cross contamination
e.g. not located next to a malting
of yeast
factory with high airborne levels
General
The layout and design should aim
 Minimize risks of errors
 Permit effective cleaning
to:
 Permit effective maintenance
 Avoid cross-contamination, build-up of dirt and dust
 Avoid any adverse effect on the quality of products
Design Principles
 Keep in mind: Material flow, People flow, Process flow
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12. (b) Design: Suitable design
 to facilitate good sanitation
 Cleaning and disinfecting
 Maximum protection against entry of
 Procedure for rodent and pest control
insects, birds and animals
(c) Construction
Suitable materials
Electrical supply
Suitable lighting (especially for visual on-line checks)
Temperature and relative humidity control
Appropriate and effective ventilation
 These may affect products during manufacture or storage as well
as functioning of equipment
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13. (d) Design of areas for weighing of materials
 Proper air supply
 Dust control measures (including extraction
 Easily cleanable surfaces
 No areas for dust accumulation
 Protection of material, product and operator
of dust and air)
(e) Maintenance
• Careful maintenance done
• Repairs and maintenance should not present any
quality of the products
Specific areas
 Ancillary areas
 Storage areas
 Weighing areas
 Production areas
 Quality control areas
hazard to the
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14. AncillaryAreas
 Rest and refreshment rooms separate from manufacturing and
quality control areas
 Changing,
numbers
washing and toilet areas accessible and appropriate
 Maintenance workshops separated from production
Storage areas
Materials and products protected from weather
 Storage areas of sufficient capacity
 Orderly storage of categories of materials and products
 Separate and segregated areas: starting materials, packaging
materials, intermediates, bulk, finished products, quarantined,
released, rejected, returned and recalled products and materials
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15.  Appropriate temperature and relative humidity conditions within
defined limits
 Good storage conditions: clean, dry and appropriate lights
 Quarantine area: clearly marked and access restricted
 A separate sampling area : no risk for
cross-contamination
Weighing areas
Weighing operations – in separated areas
Appropriate design
Provision for dust control
Smooth, impervious, durable, easy-to-clean
Cleaning procedures and records
Documentation, e.g. SOPs, and records
contamination or
finishes
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16. Production areas
 Minimize risk of cross-contamination:
 Dedicated and self-contained facilities for some products such
 highly sensitizing materials (e.g. penicillins)
 biological preparations (e.g. live microorganisms)
 Separate facilities for other products such as some antibiotics,
hormones, cytotoxic substances
 Non-pharmaceuticals normally not in the same facility, e.g.
pesticides, herbicides
 Layout in accordance with sequence of production
 Appropriate cleanliness level
 Orderly and logical positioning of equipment
 minimizes risk of contamination, mix-ups and missing
production steps
as
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17. Layout to avoid mix-ups and cross-contamination

 Interior surfaces (walls, floors, ceilings) – smooth, free from
cracks and open joints
No shedding of particles
Easy and effective cleaning permitted
No bricks, tiles, wood or sliding doors where residue can collect
Windows should not open to the outside







Effective ventilation with air control facilities
Including filtration of air to a sufficient level to prevent
contamination and cross-contamination – also external environment
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Control of temperature and relative humidity where necessary

18. Quality Control areas
QC laboratories should be separate from production areas
Separate areas for biological,
methods
2. Personnel
Personnel requirements:
Adequate number of persons
With necessary qualifications
With practical experience
microbiological and radioisotope
 All personnel should be aware of
 Must receive training in GMP:
Initial training
Continuing training
Including hygiene standards
GMP
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19.  Motivated to
 support the establishment and maintain high-quality standards
 Prevent unauthorized
 To production areas
 Storage areas
access
 Quality control
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20. 3. Sanitation and Hygiene
 High level of sanitation and
manufacturing. It covers:
 Personnel
 Premises
hygiene practiced – in every aspect of
 Equipment and apparatus
 Production materials and containers
 Products for cleaning and disinfection
 All potential sources of cross-contamination
 Personal Hygiene
 Health examinations:
Before and during employment
Periodic eye examinations for those who do visual inspections
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21.  Training:
 Practices in personal hygiene
 Written procedures and instructions
entering production area
 Illness or open lesions:
May affect the quality of products
Should not handle starting materials,
products, etc.
report to supervisors
- to wash hands before
intermediates or finished
 Direct contact between product and operator:
Should be avoided
Starting materials, primary packaging materials,
bulk product
intermediate and
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22.  Protection of product from contamination:
 Clean clothes appropriate to personnel activities
 Including hair covering (e.g. caps)
 Check change rooms/changing facilities
Hand washing, signs, drying of hands
Used clothing stored in separate closed containers while
awaiting cleaning
•Smoking, eating and drinking not allowed in
laboratories and storage areas
•No chewing (e.g. gum), or keeping food or drinks
•No plants kept inside these areas
•Toilets should not open directly into production or
production areas,
allowed
storage areas
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23. 4. Equipment
Objectives
 To review the requirements for equipment
 Selection, design, use and maintenance
Principle
 Equipment must be
 Located, designed, constructed, adapted,
operations to be carried out
 Equipment layout and design must aim:
maintained to suit the
 to
 to
minimize risks of error
permit effective cleaning and maintenance
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24. 5. Documentation
General Principles
 Good documentation is an essential part of the QA system
 Should exist for all aspects of GMP
 Purpose of documentation
Defines specifications and procedures for all materials
methods of manufacture and control
Ensures all personnel know what to do and when to do it
and
Ensure that authorized persons
for release of product
have all information necessary
Ensures availability of data for validation, review and
statistical analysis
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25.  Design and use
Depends upon manufacturer
Some documents combined into one, sometimes separate


 Why are documents so important?
 Communication, Cost,Audit trail
 Documents should be
 Designed, prepared, reviewed, distributed
 Comply with marketing authorization
with care
 Approval of documentation
 Approved, signed and dated by appropriate responsible persons
 No document should be changed without authorization and approva
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26. 6. Validation
 V
alidation is an essential part of GMP
, and an element of QA
V
alidation: The concept of validation was first proposed by Food and Drug
Administration officials in May 11, 1987 in order to improve the quality of
pharmaceuticals.
US-FDA:
“Establishing documented evidence which provides a high degree of
assurance that a specific process will consistently produce a product
meeting its pre-determined specifications and quality attributes.”
Qualification and Validation
 The term qualification is normally used for equipment, utilities and
systems
 The term validation is normally used for processes
 In this sense, qualification is part of validation
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27. Approaches to validation
 Two basic approaches:
1. Evidence obtained through testing (prospective and concurrent
validation), and
2. Analysis
validation)
of accumulated (historical) data (retrospective
 Whenever possible, prospective validation is preferred.
 Retrospective validation is no longer encouraged
 Retrospective validation is not applicable to sterile products
Prospective Process Validation (also called premarket validation)
This validation usually carried out by research and development team
 A small-scale batch (pilot project) of a drug product produced in
preparation for a full-scale batch.
 Prior to distribution either of a new product OR
 product made under a revised manufacturing process 31

28. Concurrent Process Validation:
 Conducted at the industrial scale.
 Carried out when the established formulation transfer form lab
(pilot batch) scale to industrial scale.
Revalidation
Carried out when there is any change or replacement in formulation,
equipment plans or site location, batch size and in
batches that do not meet product specifications.
the case of sequential
. Validation should be performed:
V
alidation in accordance with written protocols.
 Awritten report on the outcome to be produced.
 V
alidation should be performed over a period of time, e.g.
 At least three consecutive batches (full production scale) to demonstrate
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consistency.

29. Qualification
 Qualification should be completed before process validation is
performed
• Start from the design phase of the premises,
system
Qualification stages
 There are four stages of qualification:
 Design qualification (DQ);
equipment, utilities and
Installation qualification (IQ);
 Operational qualification (OQ); and
Performance qualification (PQ).
 All SOPs for operation, maintenance and
during qualification
 Training provided and records maintained
calibration should be prepared
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30.  Design qualification: Provides documented evidence that the design
specifications were met
 Installation qualification: Provides documented evidence that the
installation was complete and satisfactory
 During IQ:
 Purchase specifications, drawings, manuals, spare parts lists and
vendor details should be verified
Control and measuring devices should be calibrated
Operational qualification: Provides documented evidence that utilities,
systems or equipment and all its components operate in accordance with
operational specifications
Performance qualification: Provides documented evidence that utilities, systems
or equipment and all its components can consistently perform in accordance with
the specifications under routine use
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