GMP and CGMP

GMP AND CGMP
Pharmatalks Community
WHAT IS GMP ?
 GMP is that part of Quality assurance which

ensures that the products are consistently
manufactured and controlled to the Quality
standards appropriate to their intended use
 "GMP" - A set of principles and procedures which,

when followed by manufacturers for therapeutic
goods, helps ensure that the products
manufactured will have the required quality.
2
WHAT IS CGMP ?
 Usually see “cGMP” – where c = current, to emphasize that the

expectations are dynamic
3
QUALITY DEFINITION
 Quality of a medicinal product is measured by it’s fitness for purpose .

Safety and efficacy are not separable from Quality but part of it
 Quality Safety Efficacy X
Quality
Safety Efficacy
4
5
GOOD MANUFACTURING PRACTICES
 A basic tenet 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
SOME OF THE MAIN RISKS ARE
 unexpected contamination of products, causing damage

to health or even death.
 incorrect labels on containers, which could mean that

patients receive the wrong medicine.
 insufficient or too much active ingredient, resulting in

ineffective treatment or adverse effects.
7
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.
8
GMP HELPS BOOST PHARMACEUTICAL
EXPORT OPPORTUNITIES
 Most countries will only accept import and

sale of medicines that have been
manufactured to internationally recognized
GMP.
 Governments seeking to promote their

countries export of pharmaceuticals can do
so by making GMP mandatory for all
pharmaceutical production and by training
their inspectors in GMP requirements.
9
GMP COVERS…
 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 documented proof that

correct procedures are consistently followed at each step
in the manufacturing process - every time a product is
made.
10
GMP
 The Quality of a formulation or a bulk drug depends on the Quality

of those
producing it
 GMP is the magic key that opens the door of the Quality
 In matter of GMP, swim with the current and in matter of Quality
stand like a rock!
11
QA, GMP & QC INTER-RELATIONSHIP
QA
GMP
QC
12
It is the sum total of the

organized arrangements
with the objective of
ensuring that products
will be of the quality
required for their QA
intended use
13
Is that part of Quality

Assurance aimed at
ensuring that
products are
consistently
manufactured to a GMP
quality appropriate to
their intended use
14
Is that part of GMP

concerned with sampling,
specification & testing,
documentation & release
procedures which ensure
that the necessary & QC
relevant tests are
performed & the product is
released for use only after
ascertaining it’s quality
15
QC AND QA
 QC is that part of GMP which  QA is the sum total of

is concerned with sampling, organized arrangements
made with the object of
specifications, testing and ensuring that product will be
with in the organization, of the Quality required by
documentation,and release their intended use.
procedures which ensure that
the necessary and relevant
tests are carried out
16
QC AND QA
 Operational laboratory  All those planned or

techniques and activities systematic actions
used to fulfill the necessary to provide
requirement of Quality adequate confidence that a
product will satisfy the
requirements for quality
17
QC AND QA
 QC is lab based  QA is company based
18
GMP GUIDELINES
 GMP as per Schedule “M”
www.cdsco.nic.in
 GMP as per WHO
www.who.int
 GMP as per MCA now known as MHRA

www.mca.gov.uk
 GMP as per TGA
www.tga.gov.au
 GMP as per US FDA
www.fda.gov
 GMP as per ICH guidelines

www.ich.org
22/10/2008 Department of Pharmaceutics 19
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 Bio technological products
 GMP in Nutraceuticals and cosmeceuticals
 GMP in Homeopathic medicines
20
GMP
 Good Manufacturing Practice

 Good Management Practice
 Get More Profit
 Give more Production
 GMP Training with out tears
21
GMP
 All past GMPs are history….It is looking like in rear view mirror
and driving
22
TEN PRINCIPLES OF GMP
1. Design and construct the facilities and equipment's properly

2. Follow written procedures and Instructions
3. Document work
4. Validate work
5. Monitor facilities and equipment
6. Write step by step operating procedures and work on
instructions
7. Design ,develop and demonstrate job competence
8. Protect against contamination
9. Control components and product related processes
10. Conduct planned and periodic audits
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BEYOND GMP
 Reduce pollution -→ Zero discharge

 Adaptation of environment friendly methods
 Consideration for better and healthier life tomorrow
 Consideration of ethics in life
 One should begin with end in mind otherwise it will be the
beginning of the end
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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 and 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)
25
LIST OF IMPORTANT DOCUMENTS IN GMP
 Policies
 SOP
 Specifications
 MFR (Master Formula Record)
 BMR
 Manuals
 Master plans/ files
 Validation protocols
 Forms and Formats
 Records
26
10 ATTRIBUTES OF A GOOD
DOCUMENT
1. Accurate
2. Clear
3. Complete
4. Consistent
5. Indelible
6. Legible
7. Timely
8. Direct
9. Authentic
10. Authorized
27
CERTIFYING AGENCIES
 ICH. www.ich.org
 WHO. www.who.int
 US FDA. www.fda.gov
 EU/EMEA. www.emea.europa.eu
28
HOW DO GMPS OF DIFFERENT COUNTRIES
COMPARE?
At a high level, GMPs of various nations are very similar;

most require things like:
➢ Equipment and facilities being properly

designed, maintained, and cleaned
➢ Standard Operating Procedures (SOPs) be
written and approved
➢ An independent Quality unit (like Quality
Control and/or Quality Assurance)
➢ Well trained personnel and management
29
CGMP FOR FINISHED PHARMACEUTICALS
1. General Provision
2. Organization & Personnel
3. Building & Facilities
4. Equipment
5. Control of Components & Drug Product Containers & Closures
6. Production & Process Control
7. Packaging & Labeling Control
8. Handling & Distribution
9. Laboratory Control
10. Records & Reports
11. Returned & Salvaged Drugs
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GENERAL PROVISION
1. Scope
2. Definitions
31
ORGANIZATION & PERSONNEL
1. Responsibilities of quality control unit.
2. Personnel qualifications.
3. Personnel responsibilities.
4. Consultants.
32
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.
33
EQUIPMENT
1. Equipment design, size, and location.

2. Equipment construction.
3. Equipment cleaning and maintenance.
4. Automatic, mechanical, and electronic equipment.
5. Filters.
34
CONTROL OF COMPONENTS & DRUG
PRODUCT CONTAINERS &
CLOSURES
1. General requirements.
2. Receipt & storage of untested components, drug product
containers, and closures.
3. Testing and approval or rejection of components, drug
product containers, and closures.
4. Use of approved components, drug product containers, and
closures.
5. Retesting of approved components, drug product
containers, and closures.
6. Rejected components, drug product containers, and
closures.
7. Drug product containers and closures.
35
PRODUCTION & PROCESS CONTROL
1. Written procedures; deviations.

2. Charge-in of components.
3. Calculation of yield.
4. Equipment identification.
5. Sampling and testing of in-process materials and
drug products.
6. Time limitations on production.
7. Control of microbiological contamination.
8. Reprocessing.
36
PACKAGING & LABELING CONTROL
1. Materials examination and usage criteria.

2. Labeling issuance.
3. Packaging and labeling operations.
4. Tamper-evident packaging requirements for over-the-
counter (OTC) human drug products.
5. Drug product inspection.
6. Expiration dating.
37
HANDLING & DISTRIBUTION
1. Warehousing procedures.
2. Distribution procedures.
38
LABORATORY CONTROL
2. Testing and release for distribution.
3. Stability testing.
4. Special testing requirements.
5. Reserve samples.
6. Laboratory animals.
7. Penicillin contamination.
39
RECORDS & REPORTS
2. Equipment cleaning and use log.
3. Component, drug product container, closure, and labeling
records.
4. Master production and control records.
5. Batch production and control records.
6. Production record review.
7. Laboratory records.
8. Distribution records.
9. Complaint files.
40
RETURNED & SALVAGED DRUG
PRODUCTS
1. Returned drug products.

2. Drug product salvaging.
41
THANK YOU
42

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GMP AND CGMP

 GMP is that part of Quality assurance which

 "GMP" - A set of principles and procedures which,

 Usually see “cGMP” – where c = current, to emphasize that the

 Quality of a medicinal product is measured by it’s fitness for purpose .

 Quality Safety Efficacy X

 A basic tenet of GMP is that quality cannot be

 It is designed to minimize the risks involved in any

 unexpected contamination of products, causing damage

 incorrect labels on containers, which could mean that

 insufficient or too much active ingredient, resulting in

 A poor quality medicine may contain toxic substances that have

 A medicine that contains little or none of the claimed ingredient will

 Most countries will only accept import and

 Governments seeking to promote their

 ALL aspects of production; from the starting materials,

 Detailed, written procedures are essential for each process

 There must be systems to provide documented proof that

 The Quality of a formulation or a bulk drug depends on the Quality

It is the sum total of the

Is that part of Quality

Is that part of GMP

 QC is that part of GMP which  QA is the sum total of

 Operational laboratory  All those planned or

 QC is lab based  QA is company based

 GMP as per Schedule “M”

 GMP as per MCA now known as MHRA

 GMP as per ICH guidelines

 GMP in solid dosage forms

 Good Manufacturing Practice

1. Design and construct the facilities and equipment's properly

 Reduce pollution -→ Zero discharge

 In fact Cost benefits – positive cost benefits of

At a high level, GMPs of various nations are very similar;

➢ Equipment and facilities being properly

1. Responsibilities of quality control unit.

1. Design and construction features.

1. Equipment design, size, and location.

1. Written procedures; deviations.

1. Materials examination and usage criteria.

1. Returned drug products.

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