GMP MANUAL (Base incl. current update)
Good Manufacturing Practice & Implementation
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Beschreibung
In files 4 and 5 you can find important GMP regulations from Europe, PIC/S, ICH, USA and WHO. Each regulation has a separate index.
On the CD-Rom you can find the total contents of the GMP MANUAL with a professional search engine to find the best reference straight away.
Files 1-3
- Quality management systems
- Personnel
- Quality control
- Documentation
- Contract Manufacturing
- Inspection
- Quality Assurance tools
- Clean rooms
- Equipment and facilities
- Pharmaceutical water systems
- Qualification
- Process validation
- Cleaning validation
- Computer system validation
- Production
- Sterile production
- Packaging
- Research & Development
Files 4-5
- EU-GMP-Guideline including 18 annexes
- FDA-Guidelines (USA)
- Code of Federal Regulations, Part 210, 211, 11
- Guideline on general principles of process validation
- Guide to inspection of high purity water systems
- Guide to inspection of validation of cleaning processes
- Guide to inspection of oral solid dosage forms
- Guide to inspection of validation documentation (lost guide)
- Guide to inspection of computerized systems in drug processing
- Guide to inspection of pharmaceutical quality control laboratories
- Guidance for industry: Investigating Out of Specification (OOS) Test Results for pharmaceutical Production
- ICH Guidelines
- Q1A
- Q1B
- Q1C
- Q2A
- Q2B
- Q7
- Q9
- PIC/S-Guidelines
- PI 006 Recommendations on Validations Master Plan, …
- PI 011 Good Practices for computerised Systems in Regulated “GXP” Environments
- WHO-Guidelines (Guide to good storage practices for pharmaceuticals)
Autor*in
Themen in »GMP MANUAL (Base incl. current update)«
GMP Good Manufacturing Practice GMP in Practice GMP regulations Pharmaceutical industry change control contract manufacturing languages: English production of steril drugs qualification research and development validation (cleaning, process, computer)