FDA publishes ICH Q9 Draft Document
Register now for ECA's GMP Newsletter
Since the end of last year, the ICH Q9 document on quality risk management has been in stage 2 of the ICH process for publishing ICH documents as a draft revision 1. Now, the draft document has also been published by the FDA on its website and is available for comments.
Under Draft revision of ICH Q9 Quality Risk Management Guideline published you could already read about the ICH Q9 draft document - as well as about the comments provided by an ECA Expert Group; see Comments on the new ICH Q9 Guideline Q9 (Quality Risk Management) published.
The FDA has now also published the draft document on its website as "Draft Guidance for Industry" dated 14 June 2022. Comments on the draft document can be submitted online or in writing to the FDA.
You can find the FDA information at Q9(R1) Quality Risk Management on the FDA website.
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