Pharma GMP News of the Week: 2-January-2022
Period: December 26, 2021 to January 1, 2022
FDA published “Questions and Answers on Questions and Answers: Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations”
Date of release: December 29, 2021
On December 29, FDA published important Q&A regarding Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations. Key questions cover under this Q & A are:
“• What prompted development of the Concept of Operations (ConOps)?
• How does this effort relate to the recently announced Program Alignment initiative?
• Are there any additional details available regarding changes in timelines and communications for the specific inspection types?
• Can all facility owners expect final inspection classification communications within 90 days of inspection closing?
• How does FDA communicate the final inspection classification?
• Is the agency updating internal policies and procedural documents to reflect the ConOps?
• Will domestic and international facilities be evaluated differently?
• Will the ConOps help address problems at manufacturing facilities that have impacted approval of drug applications? “
For further reading, refer to the following link.
Reflation on 2021: Guidance and important news published by different regulatory agencies and organizations in the year 2021.
|Agency||Description important updates for pharmaceuticals|
|EU||6 Important Guidelines by EU in 2021|
|MHRA||Several guidelines and 11+ important blog post by MHRA in 2021|
|US-FDA||12 Important Final Guidelines and 8 Draft Guidelines by US FDA in 2021|
|ICH||8 Important updates by ICH in 2021|