GMP AND cGMP CONSIDERATIONS
By

Dr. Basavaraj K. Nanjwade M.Pharm., Ph.D.
Associate Professor
Department of Pharmaceutics
...
What is GMP ?


GMP is that part of Quality assurance
which ensures that the products are
consistently manufactured and c...
What is cGMP ?
 Usually

see “cGMP” – where c =
current, to emphasize that the
expectations are dynamic

22/10/2008

Depa...
Quality Definition
 Quality

of a medicinal product is
measured by it’s fitness for purpose .
Safety and efficacy are not...
22/10/2008

Department of Pharmaceutics

5
Good Manufacturing Practices


A basic tenet of GMP is that quality cannot
be tested into a batch of product but must
be ...
Some of the main risks are
– unexpected contamination of products, causing
damage to health or even death.
– incorrect lab...
Why GMP is important
– A poor quality medicine may contain
toxic substances that have been
unintentionally added.
– A medi...
GMP helps boost pharmaceutical
export opportunities
 Most

countries will only accept import
and sale of medicines that h...
GMP Covers…


ALL aspects of production; from the starting
materials, premises and equipment to the
training and personal...
GMP
 The

Quality of a formulation or a
bulk drug depends on the Quality of
those
producing it
 GMP is the magic key tha...
QA, GMP & QC inter-relationship
QA
GMP
QC

22/10/2008

Department of Pharmaceutics

12
QA, GMP & QC inter-relationship
QA

It is the sum total of the
organized arrangements
with the objective of
ensuring that ...
QA, GMP & QC inter-relationship
GMP

Is that part of Quality
Assurance aimed at
ensuring that products
are consistently
ma...
QA, GMP & QC inter-relationship
QC
Is that part of GMP concerned
with sampling, specification
& testing, documentation &
r...
QC and QA


QC is that part of GMP  QA is the sum total
which is concerned with
of organized
sampling,
arrangements
spec...
QC and QA


Operational
laboratory
techniques and
activities used to
fulfill the
requirement of
Quality

22/10/2008



A...
QC and QA



QC is lab based

22/10/2008



QA is company
based

Department of Pharmaceutics

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 ...
GMP
GMP
 GMP
 GMP
 GMP
 GMP
 GMP
 GMP
 GMP


22/10/2008

in solid dosage forms
in semisolid dosage forms
in Liquid...
GMP
 Good

Manufacturing Practice
 Good Management Practice
 Get More Profit
 Give more Production
 GMP Training with...
GMP
 All

past GMPs are history….It is
looking like in rear view mirror and
driving

22/10/2008

Department of Pharmaceut...
Ten Principles of GMP
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

Design and construct the facilities and
equipments properly
Follow w...
Beyond GMP
 Reduce

pollution - Zero discharge
 Adaptation of environment friendly
methods
 Consideration for better a...
Cost of effective GMP
In fact Cost benefits – positive cost
benefits of GMP/QA
 Good plant lay out, Smooth work flows,
Ef...
List of important documents in GMP











Policies
SOP
Specifications
MFR (Master Formula Record)
BMR
Manual...
10 attributes of a good document
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

Accurate
Clear
Complete
Consistent
Indelible
Legible
Time...
Certifying agencies
 ICH. www.ich.org
 WHO. www.who.int
 US

FDA. www.fda.gov

 EU/EMEA. www.emea.europa.eu

22/10/200...
How do GMPs of different countries
compare?
At a high level, GMPs of various nations are very
similar; most require things...
cGMP For Finished Pharmaceuticals
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.

General Provision
Organization & Personnel
Building ...
General Provision
1.

Scope

2.

Definitions

22/10/2008

Department of Pharmaceutics

31
Organization & Personnel
1.

Responsibilities of quality control
unit.

2.

Personnel qualifications.

3.

Personnel respo...
Building & Facilities
1.
2.
3.
4.
5.
6.
7.
8.

Design and construction features.
Lighting.
Ventilation, air filtration, ai...
Equipment
1.
2.
3.
4.
5.

Equipment design, size, and
location.
Equipment construction.
Equipment cleaning and
maintenance...
Control of Components & Drug
Product Containers & Closures
1.
2.
3.

4.
5.
6.
7.

General requirements.
Receipt & storage ...
Production & Process Control
1.
2.
3.
4.
5.
6.
7.
8.

Written procedures; deviations.
Charge-in of components.
Calculation...
Packaging & Labeling Control
1.
2.
3.
4.

5.
6.

Materials examination and usage
criteria.
Labeling issuance.
Packaging an...
Handling & Distribution
1.

Warehousing procedures.

2.

Distribution procedures.

22/10/2008

Department of Pharmaceutics...
Laboratory Control
1.
2.
3.
4.
5.
6.
7.

General requirements.
Testing and release for distribution.
Stability testing.
Sp...
Records & Reports
1.
2.
3.
4.
5.

6.
7.
8.
9.

General requirements.
Equipment cleaning and use log.
Component, drug produ...
Returned & Salvaged Drug
Products
1.
2.

Returned drug products.
Drug product salvaging.

22/10/2008

Department of Pharma...
THANK YOU
E-mail: bknanjwade@yahoo.co.in
Cell No: 9448716277

22/10/2008

Department of Pharmaceutics

42
Upcoming SlideShare
Loading in...5
×

GMP and cGMP Considerations Training by KLE University

4,644

Published on

Published in: Business, Technology
1 Comment
1 Like
Statistics
Notes
No Downloads
Views
Total Views
4,644
On Slideshare
0
From Embeds
0
Number of Embeds
13
Actions
Shares
0
Downloads
0
Comments
1
Likes
1
Embeds 0
No embeds

No notes for slide

Transcript of "GMP and cGMP Considerations Training by KLE University"

  1. 1. GMP AND cGMP CONSIDERATIONS By Dr. Basavaraj K. Nanjwade M.Pharm., Ph.D. Associate Professor Department of Pharmaceutics KLE University BELGAUM - 590010
  2. 2. 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. 22/10/2008 Department of Pharmaceutics 2
  3. 3. What is cGMP ?  Usually see “cGMP” – where c = current, to emphasize that the expectations are dynamic 22/10/2008 Department of Pharmaceutics 3
  4. 4. 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 Quality Safety Efficacy 22/10/2008 Department of Pharmaceutics 4 X
  5. 5. 22/10/2008 Department of Pharmaceutics 5
  6. 6. 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. 22/10/2008 Department of Pharmaceutics 6
  7. 7. 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. 22/10/2008 Department of Pharmaceutics 7
  8. 8. 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. 22/10/2008 Department of Pharmaceutics 8
  9. 9. 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. 22/10/2008 Department of Pharmaceutics 9
  10. 10. 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. 22/10/2008 Department of Pharmaceutics 10
  11. 11. 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! 22/10/2008 Department of Pharmaceutics 11
  12. 12. QA, GMP & QC inter-relationship QA GMP QC 22/10/2008 Department of Pharmaceutics 12
  13. 13. 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 22/10/2008 Department of Pharmaceutics 13
  14. 14. QA, GMP & QC inter-relationship GMP Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use 22/10/2008 Department of Pharmaceutics 14
  15. 15. QA, GMP & QC inter-relationship QC 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 22/10/2008 Department of Pharmaceutics 15
  16. 16. QC and QA  QC is that part of GMP  QA is the sum total which is concerned with of organized sampling, arrangements specifications, testing made with the and with in the object of ensuring organization, that product will be documentation,and of the Quality release procedures which ensure that the required by their necessary and relevant intended use. tests are carried out 22/10/2008 Department of Pharmaceutics 16
  17. 17. QC and QA  Operational laboratory techniques and activities used to fulfill the requirement of Quality 22/10/2008  All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality Department of Pharmaceutics 17
  18. 18. QC and QA  QC is lab based 22/10/2008  QA is company based Department of Pharmaceutics 18
  19. 19. 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
  20. 20. GMP GMP  GMP  GMP  GMP  GMP  GMP  GMP  GMP  22/10/2008 in solid dosage forms in semisolid dosage forms in Liquid orals in Parenterals Production in Ayurvedic medicines in Bio technological products in Nutraceuticals and cosmeceuticals in Homeopathic medicines Department of Pharmaceutics 20
  21. 21. GMP  Good Manufacturing Practice  Good Management Practice  Get More Profit  Give more Production  GMP Training with out tears 22/10/2008 Department of Pharmaceutics 21
  22. 22. GMP  All past GMPs are history….It is looking like in rear view mirror and driving 22/10/2008 Department of Pharmaceutics 22
  23. 23. Ten Principles of GMP 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Design and construct the facilities and equipments properly Follow written procedures and Instructions Document work Validate work Monitor facilities and equipment Write step by step operating procedures and work on instructions Design ,develop and demonstrate job competence Protect against contamination Control components and product related processes Conduct planned and periodic audits 22/10/2008 Department of Pharmaceutics 23
  24. 24. 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 22/10/2008 Department of Pharmaceutics 24
  25. 25. 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)  22/10/2008 Department of Pharmaceutics 25
  26. 26. List of important documents in GMP           Policies SOP Specifications MFR (Master Formula Record) BMR Manuals Master plans/ files Validation protocols Forms and Formats Records 22/10/2008 Department of Pharmaceutics 26
  27. 27. 10 attributes of a good document 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Accurate Clear Complete Consistent Indelible Legible Timely Direct Authentic Authorized 22/10/2008 Department of Pharmaceutics 27
  28. 28. Certifying agencies  ICH. www.ich.org  WHO. www.who.int  US FDA. www.fda.gov  EU/EMEA. www.emea.europa.eu 22/10/2008 Department of Pharmaceutics 28
  29. 29. 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 22/10/2008 Department of Pharmaceutics 29
  30. 30. cGMP For Finished Pharmaceuticals 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. General Provision Organization & Personnel Building & Facilities Equipment Control of Components & Drug Product Containers & Closures Production & Process Control Packaging & Labeling Control Handling & Distribution Laboratory Control Records & Reports Returned & Salvaged Drugs 22/10/2008 Department of Pharmaceutics 30
  31. 31. General Provision 1. Scope 2. Definitions 22/10/2008 Department of Pharmaceutics 31
  32. 32. Organization & Personnel 1. Responsibilities of quality control unit. 2. Personnel qualifications. 3. Personnel responsibilities. 4. Consultants. 22/10/2008 Department of Pharmaceutics 32
  33. 33. 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. 22/10/2008 Department of Pharmaceutics 33
  34. 34. Equipment 1. 2. 3. 4. 5. Equipment design, size, and location. Equipment construction. Equipment cleaning and maintenance. Automatic, mechanical, and electronic equipment. Filters. 22/10/2008 Department of Pharmaceutics 34
  35. 35. Control of Components & Drug Product Containers & Closures 1. 2. 3. 4. 5. 6. 7. General requirements. Receipt & storage of untested components, drug product containers, and closures. Testing and approval or rejection of components, drug product containers, and closures. Use of approved components, drug product containers, and closures. Retesting of approved components, drug product containers, and closures. Rejected components, drug product containers, and closures. Drug product containers and closures. 22/10/2008 Department of Pharmaceutics 35
  36. 36. Production & Process Control 1. 2. 3. 4. 5. 6. 7. 8. Written procedures; deviations. Charge-in of components. Calculation of yield. Equipment identification. Sampling and testing of in-process materials and drug products. Time limitations on production. Control of microbiological contamination. Reprocessing. 22/10/2008 Department of Pharmaceutics 36
  37. 37. Packaging & Labeling Control 1. 2. 3. 4. 5. 6. Materials examination and usage criteria. Labeling issuance. Packaging and labeling operations. Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. Drug product inspection. Expiration dating. 22/10/2008 Department of Pharmaceutics 37
  38. 38. Handling & Distribution 1. Warehousing procedures. 2. Distribution procedures. 22/10/2008 Department of Pharmaceutics 38
  39. 39. Laboratory Control 1. 2. 3. 4. 5. 6. 7. General requirements. Testing and release for distribution. Stability testing. Special testing requirements. Reserve samples. Laboratory animals. Penicillin contamination. 22/10/2008 Department of Pharmaceutics 39
  40. 40. Records & Reports 1. 2. 3. 4. 5. 6. 7. 8. 9. General requirements. Equipment cleaning and use log. Component, drug product container, closure, and labeling records. Master production and control records. Batch production and control records. Production record review. Laboratory records. Distribution records. Complaint files. 22/10/2008 Department of Pharmaceutics 40
  41. 41. Returned & Salvaged Drug Products 1. 2. Returned drug products. Drug product salvaging. 22/10/2008 Department of Pharmaceutics 41
  42. 42. THANK YOU E-mail: bknanjwade@yahoo.co.in Cell No: 9448716277 22/10/2008 Department of Pharmaceutics 42

×