Bioburden in EU GMP Annex 1: Risk Assessment

WEBINAR

Motivated by the need to reflect changes in both the regulatory and manufacturing environments, the long-awaited revised Annex 1 on the Manufacture of Sterile Medicinal Products was published by the European Commission on August 25th, 2022. The new revision clarifies that the intent of Annex 1 is to provide guidance for the manufacture of sterile products in general, comprised of sections on active substance, excipient, primary packaging material and finished dosage form.

Some of the principles included in the Annex 1 guidance may be applied to other non-sterile products where filtration is utilized for bioburden reduction without a sterility claim.

Given the potential variability in filtration performance for these non-sterile products, the overall Contamination Control Strategy (CCS) becomes even more important for regulators to assess the overall bioburden control during manufacturing. As a result, it is critical to have a detailed knowledge of the process and all potential sources of contamination, which is needed for development of a comprehensive CCS as described in Annex 1.

Join our panel discussion on January 18, 2023, where experts on regulation, filtration, sampling and quality control will share insights on how to overcome these challenges and ensure a successful bioburden reduction and testing, in compliance with the new EU GMP Annex 1 regulation coming into operation on August 25th, 2023.

In this webinar, you will learn:

• Key requirements for a meaningful risk assessment
• Best practices to reduce bioburden
• Latest advances in bioburden testing solutions