Interface of risk management and contamination control
CLS Ingenieur GmbH · Christoph Brewi
17/10/2024, 10:30 · Room 2 · DE
The implementation of a contamination control strategy (CCS) in accordance with Annex 1 brings a number of benefits and requirements for the pharmaceutical industry. The strategy ensures stringent control over the entire manufacturing process, resulting in increased safety and quality of pharmaceutical products and defines clear specifications that meet regulatory standards. The requirement to reduce contamination risks has long been part of GMP regulations. The CCS in accordance with Annex 1 is therefore the logical continuation of this concept, respectively the necessary extension, to be applied in manufacturing of sterile pharmaceutical products. By implementing this strategy, companies can ensure that their planning and production practices comply with regulatory requirements. Applying the principles of quality risk management (QRM) is an essential part in the CCS implementation, from planning to routine operations. With the help of appropriate risk analyses potential contaminations in aseptic production are identified and appropriate control measures established.Agenda
- Interaction of practices with collective effectiveness
- An old concept with new expectations
- Challenges in creating a contamination control strategy
- Hazards and risks in aseptic manufacturing
- Essential measures in contamination control