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WHO Guideline Submission of documentation for a multisource (generic) finished pharmaceutical product: quality part
Short Title:
Annex 6, WHO Technical Report Series 986
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, www.who.int
Document Type:
Guideline
Content:
Assistance applicants in the preparation of the Quality Module of PDs for multisource products by providing clear general guidance on the format of these dossiers
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