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.
WHO Guidelines on active pharmaceutical ingredient master file procedure
Short Title:
Annex 4, WHO Technical Report Series 948, 2008
Origin/Publisher:
WHO headquarters, Avenue Appia 20, 1211 Geneva 27, Switzerland Telephone: (+ 41 22) 791 21 11, Facsimile (fax): (+ 41 22) 791 3111, Telex: 415 416, Telegraph: UNISANTE GENEVA
Content:
These guidelines are intended to assist applicants in the compilation of the information on APIs in their dossiers for prequalification or when submitting a variation to a dossier on a prequalifi ed product (named in the text from
now on as product dossier) when the APIMF procedure is used. It is also intended to help APIMF holders in the compilation of their APIMFs.
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