Documente Academic
Documente Profesional
Documente Cultură
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
7 | PQ Workshop, Abu Dhabi | October 2010
Good Manufacturing Practices (cont'd)
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
Premises
Primary materials
People
Procedures
Wide-ranging concept
covers all matters that individually or collectively
influence the quality of a product
Director
QA
improvement
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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