A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
2. What is CGMP ?
• Current Good Manufacturing Practice regulations enforced by the US Food and
Drug Administration (FDA).
• Provides for systems that assure proper design, monitoring, and control of
manufacturing processes and facilities.
• Assures the identity, strength, quality, and purity of drug products.
• The "C" in CGMP stands for "current," requiring companies to use technologies
and systems that are up-to-date in order to comply with the regulations.
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3. Importance of CGMP
• To assure that quality is built into the design and
manufacturing process at every step.
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4. 21 CFR Part 210
CURRENT GOOD MANUFACTURING PRACTICE IN
MANUFACTURING, PROCESSING, PACKING, OR HOLDING
OF DRUGS
• § 210.1 - Status of current good manufacturing practice regulations.
• § 210.2 - Applicability of current good manufacturing practice
regulations.
• § 210.3 - Definitions.
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5. 21 CFR Part 210
210.1 Status of the regulations
• Regulations set forth are “minimum” requirements!!!!
• Covers manufacturing, facilities and controls for Manufacturing,
processing, packaging or holding of a drug product
• Failure to comply will render the drug to be adulterated
• The person who is responsible for the failure to comply shall be
subject to regulatory action
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6. 21 CFR Part 210
210.2 Applicability of current good manufacturing practice
regulations.
• Applies to drug products for human use.
• If a person engages in only some operations subject to the
regulations in this part, and not in others, that person need only
comply with those regulations applicable to the operations in which
he or she is engaged.
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7. 21 CFR Part 210
210.3 Definitions
Act
-means the Federal Food, Drug, and Cosmetic Act.
Batch
-A specific quantity of drug/material intended to have uniform character and
quality produced under a single manufacturing order form during the same
cycle of manufacture.
Component
-Any ingredient intended for use INCLUDING those that may not appear in
such drug product.
Drug Product
- Finished dosage form
Fiber
- Any particulate with a length at least 3 times to its width
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8. • Nonfibre releasing filter, will not release fibres into the component or
drug product that is being filtered.
• Active ingredient, Any component intended to furnish pharmacological
activity
• Drug is defined by the Act as any compound that has effect in the diagnosis,
cure, mitigation, treatment or prevention of disease or to affect the structure
or function of the body of man or animals
• In-process material, Any material fabricated, compounded, blended or
derived for use in the drug product.
• Lot means a batch, or a specific identified portion of a batch, having uniform
character and quality within specified limits
• Lot number, control number, or batch number means any
distinctive, from which the complete history of drug product or other material
can be determined.
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9. • Acceptance criteria
• Representative sample
• Strength
• Gang-printed labelling means labelling derived from a sheet of
material on which more than one item of labelling is printed.
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10. 21 CFR Part 211
CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED
PHARMACEUTICALS
There are 11 subchapters
Identified by letters from A through K
Covers all sections of operations
Designed to be all encompassing (general) – DON’T
expect too many specific.
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11. 211.1 Scope
• Minimum requirements
• Applies to drugs for human use
211.3 Definitions
• Those set forth in 210.3 are applicable
SUBPART A – GENERAL PROVISIONS
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12. SUBPART B – ORGANISATION & PERSONNEL
211.22 - Responsibilities of quality control unit
211.25 - Personnel qualifications
211.28 - Personnel responsibilities
211.34 - Consultants.
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13. SUBPART C – BUILDINGS AND FACILITIES
211.42 - Design and construction features
211.44 - Lighting
211.46 - Ventilation, air filtration, air heating and cooling
211.48 - Plumbing
211.50 - Sewage and refuse
211.52 - Washing and toilet facilities
211.56 - Sanitation
211.58 - Maintenance
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14. SUBPART D – EQUIPMENT
211.63 - Equipment design, size, and
location
211.65 - Equipment construction
211.67 - Equipment cleaning and
maintenance
211.68 - Automatic, mechanical, and
electronic equipment
211.72 - Filters
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15. SUBPART E – CONTROL OF COMPONENTS AND DRUG PRODUCT
CONTAINERS AND CLOSURES
211.80 - General requirements
211.82 - Receipt and storage of untested
components, drug product containers, and
closures
211.84 - Testing and approval or rejection of
components, drug product containers, and
closures
211.86 - Use of approved components, drug product
containers, and closures
211.87 - Retesting of approved components, drug
product containers, and closures
211.89 - Rejected components, drug product
containers, and closures
211.94 - Drug product containers and closures.
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16. SUBPART F – PRODUCTION & PROCESS CONTROLS
211.100 - Written procedures; deviations
211.103 - Calculation of yield
211.105 - Equipment identification
211.110 - Sampling and testing of in-process
materials and drug products
211.111 - Time limitations on production
211.113 - Control of microbiological
contamination
211.115 - Reprocessing
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17. SUBPART G – PACKAGING AND LABELING CONTROL
211.122 Materials examination and usage criteria
211.125 Labeling issuance
211.130 Packaging and labeling operations
211.132 Tamper-resistant packaging
requirements for OTC human drug products
211.134 Drug product inspection
211.137 Expiration dating
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18. SUBPART H – HOLDING AND DISTRIBUTION
211.142 - Warehousing procedures
211.150 - Distribution procedures
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19. SUBPART I – LABORATORY CONTROLS
211.160 - General requirements
211.165 - Testing and release for distribution
211.166 - Stability testing
211.167 - Special testing requirements
211.170 - Reserve samples
211.173 - Laboratory animals
211.176 - Penicillin contamination.
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20. SUBPART J – RECORDS AND REPORTS
211.180 - General requirements
211.182 - Equipment cleaning and use log
211.184 - Component, drug product container,
closure, and labeling records
211.186 - Master production and control
records
211.188 - Batch production and control records
211.192 - Production record review
211.194 - Laboratory records
211.196 - Distribution records
211.198 - Complaint files
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21. 211.204 - Returned drug products
211.208 - Drug product salvaging
SUBPART K – RETURNED AND SALVAGED DRUG PRODUCTS
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22. CONCLUSION
CGMP compliance is not an option.
Quality should be built into the product right from the initial stage.
GMP's are very similar and are really Good Common Sense.
Good Practices cover all aspects of manufacturing activities prior to
supply.
The role and involvement of senior management is crucial.
The goal is to tell you
WHAT TO DO, NOT HOW TO DO it!
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23. References
• https://www.fda.gov/drugs/developmentapprovalprocess/manufactu
ring/ucm090016.html, Current Good Manufacturing Practice
(CGMP) Regulations (Accessed on 13th September 2017)
• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.
cfm?CFRPart=210 , 21 CFR Part 210 Guidelines (Accessed on 13th
September 2017)
• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.
cfm?CFRPart=211 , 21 CFR Part 211 Guidelines (Accessed on 13th
September 2017)
• P.P. Sharma, How to Practice GMPs, 7th ed, New Delhi, Vallabh
Publishers; 2015
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