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.

Source: https://www.fda.gov/drugs/pharmaceutical-quality-resources/questions-and-answers-integration-fda-facility-evaluation-and-inspection-program-human-drugs-concept

Reflation on 2021: Guidance and important news published by different regulatory agencies and organizations in the year 2021.

 AgencyDescription important updates for pharmaceuticals
EU6 Important Guidelines by EU in 2021
MHRASeveral guidelines and 11+ important blog post by MHRA in 2021
US-FDA12 Important Final Guidelines and 8 Draft Guidelines by US FDA in 2021
ICH8 Important updates by ICH in 2021

Click on this link to find List of Pharmaceutical guidelines published in 2021

Scroll to Top