Four JP Drafts Related to Chromatography Published for Public Comments
Recommendation
Tuesday, 24 January 2023 14.00 - 17.00 h
Register now for ECA's GMP Newsletter
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published four Japanese Pharmacopoeia (JP) drafts of General Tests and General Information related to Chromatography.
The following documents have been published:
- Draft of new General Test “<2.00> Chromatography”
- Draft of revised General Test “<2.01> Liquid Chromatography”
- Draft of revised General Test “<2.02> Gas Chromatography”
- Draft of new General Information “<G1-5-181> Control Strategies and Change Control Concepts at Each Stage of Chromatography Lifecycle” (Change Control in Lifecycle of Chromatography)
The four draft documents are available as a PDF file on the PMDA's website. The PMDA also published a Briefing Note in which the key points of these four drafts are summarised.
Comments can be submitted until November 30, 2021. For this purpose, a form for comments has to be downloaded and sent by e-mail after it has been filled in.
Related GMP News
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