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Good Manufacturing Practices Purpose and Principles of GMP: Tony Gould
Good Manufacturing Practices Purpose and Principles of GMP: Tony Gould
Tony Gould
Why GMP?
Quality is built in
– Testing is part of GMP, but alone does not provide a
good level of quality assurance
Pharmaceutical excipients
Sterile pharmaceutical products
Biological products
Pharmaceutical products containing hazardous
substances
Investigational pharmaceutical products for clinical trials i
Herbal medicinal products
Radiopharmaceutical products
Water for pharmaceutical use
HVAC for non-sterile pharmaceutical dosage forms
Validation
1. Quality assurance
2. Good manufacturing practices for pharmaceutical products
3. Sanitation and hygiene
4. Qualification and validation
5. Complaints
6. Product recalls
7. Contract production and analysis
– General
– The contract giver
– The contract accepter
– The contract
13. Equipment
14. Materials
– General
– Starting materials
– Packaging materials
– Intermediate and bulk products
– Finished products
– Rejected, recovered, reprocessed and reworked materials
– Recalled products
– Returned goods
– Reagents and culture media
– Reference standards
– Waste materials
– Miscellaneous
15. Documentation
– General
– Documents required:
• Labels
• Testing procedures
• Specifications for starting and packaging materials, for
intermediate and bulk products and for finished products
• Master formulae and Batch Processing Records
• Packaging instructions and Batch Packaging Records
• Standard Operating procedures (SOP's) and records
• Logbooks
Quality Management
Quality Assurance
GMP
Section 1 and 2
Production and Quality Control
Premises
Primary materials
People
Director
Director
QA
QA
Production
Production QC lab
QC lab Other Depts
Other Depts
1.3
Complaints handling
Self-inspection
Complaints: Principle
Thorough investigation:
– QC involved
– With special attention to establish whether "counterfeiting"
may have been the cause
– Fully recorded investigation – reflect all the details
Follow-up action
– Effective follow-up programme
– Company management to evaluate both
the report and corrective actions
8.5, 8.6
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