DRUGS AND
COSMETICS ACT
Contents of this chapter
•Definitions
•Administration of the act and rules
•Provisions related to Import
•Provisions related to Manufacture
•Provisions related to Sale
•Labeling and Packaging
•Schedules to the act and rules
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Learning Objectives
• At the end of this lecture, student will be able to
– Discuss the Provisions of GMP related to manufacture of drugs and
pharmaceuticals
– Explain the GMP guidelines
– Discuss the principles of GMP
– Discuss about Schedule M – cGMP for Finished Pharmaceuticals
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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
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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
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Principles of GMP
1. Design and construct the facilities and equipments properly
2. Follow written procedures and Instructions
3. Document and validate work
4. Monitor facilities and equipment
5. Write step by step operating procedures and work on instructions
6. Design, develop and demonstrate job competence
7. Protect against contamination
8. Control components and product related processes
9. Conduct planned and periodic audits
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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
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Schedule M – 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. General requirements
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Organization & Personnel
1. Responsibilities of quality control unit
2. Personnel qualifications
3. Personnel responsibilities
4. Consultants
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Building & Facilities
1. Design and construction features
2. Lighting
3. Ventilation, air filtration, air heating and cooling
4. Plumbing
5. Sewage
6. Washing and toilet facilities
7. Sanitation
8. Maintenance
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Equipment
1. Equipment design, size, and location
2. Equipment construction
3. Equipment cleaning and maintenance
4. Automatic, mechanical, and electronic equipment
5. Filters
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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 closure
7. Drug product containers and closures
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Production & Process Control
1. Written procedures; deviations
2. Calculation of yield
3. Equipment identification
4. Sampling and testing of in-process materials and drug products
5. Time limitations on production
6. Control of microbiological contamination
7. Reprocessing
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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
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1. Laboratory Control
2. General requirements
3. Testing and release for distribution
4. Stability testing
5. Special testing requirements
6. Reserve samples
7. Laboratory animals
8. Contamination
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Records & Reports
1. General requirements
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
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Summary
1. Design and construct the facilities and equipments properly
2. Follow written procedures and Instructions
3. Document and validate work
4. Monitor facilities and equipment
5. Write step by step operating procedures and work on instructions
6. Design, develop and demonstrate job competence
7. Protect against contamination
8. Control components and product related processes
9. Conduct planned and periodic audits