PIC/S takes over new Annex 15 on Validation/Qualification
Recommendation
17-19 September 2024
GMP Compliance and Technology for the Manufacture of Oral Solid Dosage Forms
Register now for ECA's GMP Newsletter
Mid of April the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has taken over the revised Annex 15 of the EU GMP Guide on Validation and Qualification in their GMP Guide. We reported about the Annex 15 revision in detail. The Annex 15 takeover by PIC/S was expected, but is yet interesting as now the new requirements with regard to validation and qualification will also be applicable in non-EU countries - for instance in Canada, Australia, Taiwan and Argentina.
Similar to the EU Annex 15 the document becomes effective on 1 October 2015.
Please see the PIC/S website for the Guide to Good Manufacturing Practice for Medicinal Products - Annex 15.
Related GMP News
03/04/2024
06/03/2024
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- 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