The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
PIC/S Aide Memoire on INSPECTION OF BIOTECHNOLOGY MANUFACTURES (PI 024-3)
Short Title:
PI 024-3
Origin/Publisher:
Secretariat of the Pharmaceutical Inspection Convention c/o EFTA Secretariat 9-11, rue de Varembé, CH - 1211 Geneva 20, http://www.picscheme.org
Content:
The aide memoires applies to biotech products and classical biological products for human use, but could also be used for gene-therapy and cell-therapy products. It includes also products for use in clinical trials.
The aide memoires should be considered as a non-exhaustive list of areas to be looked at during an inspection.
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
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- Sterile Manufacturing
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- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others