New GMP Annex 1 Revision, Contamination Control Strategy, and Beyond

After a long period of time, GMP Annex 1 was finally updated in August 2022. In order to comply with this necessary regulation in pharmaceutical manufacturing plants, there are several critical implementations and updates on processes, personnel, utilities, and more. This class will cover the basics of Contamination Control Strategy, how to prepare and implement it throughout the process, cleanroom classification and monitoring basis, etc.  According to the GMP Annex1 2022; A Contamination Control Strategy (CCS) should be implemented across the facility in order to define all critical control points and assess the effectiveness of all the controls (design, procedural, technical and organizational) and monitoring». Since this is a pretty new concept, this class will address it with 3 easy and “self-explanatory” steps to make it easy to remember and implement.

Course outline     Who should attend?     Course materials     Next date and location     


Course outline

  1. GMP Revision in General and Basics of a Contamination Control Strategy (CCS)
  2. Microbiological Control and Monitoring
    1. This section will discuss the current regulatory thinking about environmental monitoring. This will include points to consider when developing a risk based monitoring program; including how to evaluate real life risks when related to facility, airflows, personnel flows and material flows as well as contamination sources from the manufacturing process itself. Contamination control strategy blind spots related to environmental monitoring will be addressed as well as the importance of microbial identification, gaps in investigations, and analysis of trends.
  3. Annex 1:2022: Interpreting the Guidance for Cleaning & Disinfection Requirements.
  4. "Appropriate cleanrooms" and the characterization of airflow patterns as part of a CCS
    1. The updated International GMP Annex 1 is a significant document establishing rules with far reaching effects in medical product manufacturing. The rules established in this document call for manufacturing to be carried out in "appropriate cleanrooms", utilizing airlocks for personnel and materials that are effectively flushed with HEPA filtered air. Annex 1 requires additional cleanroom qualification and monitoring beyond the minimum testing in the ISO 14644 series of standards, and the US FDA's cGMP guidance document. This section will discuss what is an "appropriate cleanroom" and how to determine if it is effectively flushed with clean air. Case histories will be used to illustrate these points.
  5. Environmental Monitoring, Control, and Validation
  6. Personnel Training and Qualification
    1. Annex 1 revision has emphasized training and qualification as well as disqualification of aseptic personnel. Training is more than read and understand; equipping personnel with the knowledge about the contamination sources, facility, and operations can help improve personnel behavior and aseptic techniques. Annex 1 also refers to gown managements, a key contamination control blind spot that is address for the first time in any regulatory document. This section will address gown choice, gown management, gowning, and gown qualification. FDA 483 observations as well as case studies will be presented to explain Annex 1 requirements and approach to a holistic contamination control strategy.
  7. GMP Annex1 and Barrier Technologies
  8. Smoke Study” Air Visualization Studies
  9. Q&A

 

Who should attend?

Information coming soon.

Course materials

  • Copy of PowerPoint presentation


Continuing Education Units: .6 CEUs



Presenters

Hasim Solmaz, Lighthouse Worldwide Solutions
Ziva Abraham, Microrite
Richard Denk, SKAN
Norman Goldschmidt, Genesis Engineers
Morgan Polen, Microrite
Neil Simpson, Contec

Next date and location

May 9, 2024
In-person at ESTECH 2024
Planet Hollywood, Las Vegas, Nevada
Click here for details

This course is also available virtually.