Transcript GMP AND cGMP CONSIDERATIONS

GMP AND cGMP CONSIDERATIONS
Department of pharmaceutics
GMP SEAL
What is GMP ?
 GMP is a 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
GMP also………
 Good Manufacturing Practice
 Good Management Practice
 Get More Profit
 Give more Production
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.
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.
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
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.
QA, GMP & QC inter-relationship
QA
GMP
QC
Department of Pharmaceutics
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 a part of Quality Assurance aimed at
ensuring that products are
consistently manufactured to a
quality appropriate to their intended
use
QC
Is a 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
Ten Principles of GMP
Design and construct the facilities and equipments
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
1.
List of important documents in
GMP
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Policies
SOP
Specifications
MFR (Master Formula Record)
BMR (Batch Manufacturing Records)
Manuals
Master plans/ files
Validation protocols
Forms and Formats
Records
10 attributes of a good document
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Accurate
Clear
Complete
Consistent
Indelible
Legible
Timely
Direct
Authentic
Authorized
Certifying agencies
 ICH. www.ich.org
 WHO. www.who.int
 US FDA. www.fda.gov
 EU/EMEA. www.emea.europa.eu
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
cGMP For Finished
Pharmaceuticals
General Provision
Organization & Personnel
Building & Facilities
Equipment
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
Organization & Personnel
1.
Responsibilities of quality control unit.
2.
Personnel qualifications.
3.
Personnel responsibilities.
Building & Facilities
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Design and construction features.
Lighting.
Ventilation, air filtration, air heating and cooling.
Plumbing.
Sewage and refuse.
Washing and toilet facilities.
Sanitation.
Maintenance.
Pharmacy Building
Equipment
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Equipment design, size, and location.
Equipment construction.
Equipment cleaning and maintenance.
Automatic, mechanical, and electronic equipment.
Filters.
Tablet Punching Machine
Pulverizer
End Runner
Capsule Filling Machine
Control of Components & Drug
Product Containers & Closures
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2.
3.
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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.
Production & Process Control
Written procedures; deviations.
Charge-in of components.
Calculation of yield.
Equipment identification.
Sampling and testing of in-process materials
and drug products.
6. Time limitations on production.
7. Control of microbiological contamination.
8. Reprocessing.
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Packaging & Labeling Control
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Materials examination and usage criteria.
Labeling issuance.
Packaging and labeling operations.
Tamper-evident packaging requirements for overthe-counter (OTC) human drug products.
Drug product inspection.
Expiration dating.
Storage & Distribution
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Warehousing procedures.
2.
Distribution procedures.
Laboratory Control
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General requirements.
Testing and release for distribution.
Stability testing.
Special testing requirements.
Reserve samples.
Laboratory animals.
Penicillin contamination.
Records & Reports
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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.
Returned & Salvaged Drug
Products
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2.
Returned drug products.
Drug product salvaging.
References
Blackwell, John. 1906: Rumble Over ‘The Jungle’. 31 Aug. 2008.
http://www.capitalcentury.com/1906.html
FDA Food and Drug Administration. GMP Combination Handbooks. 31 Aug.
2008. http://images.google.com
The Center for Professional Advancement. Good Manufacturing Practice. 2008.
1 Sep. 2008. http://www.cfpa.com/gmp-training
The New York Times. 1906 Meat Processing Plant. 26 Jan. 2005. 31 Aug. 2008.
http://www.nytimes.com/imagepages/2005/01/26/national/26meat.ready.ht
ml
Torrent Pharmaceuticals Ltd. Pharmaceutical GMP: past, present, and future–a
review. 2008. 31. Aug. 2008.
http://www.atyponlink.com/GVR/doi/abs/10.1691/ph.2008.7319?cookieSet=1&journalCode=phm
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