QRM (Quality Risk Management) is referred to in the Annex 1 as the overall umbrella for a manufacturing site to ensure that microbial, particulate and pyrogen contamination is prevented in the final product dosage form. The knowledge about- and control over your product process, equipment, engineering and maintenance have impact on your product quality.
As the manufacture of sterile products is a complex activity, it requires specific controls and measures to ensure the quality of products manufactured. Accordingly, the manufacturer’s Pharmaceutical Quality System (PQS) should encompass and address these specific requirements of sterile product manufacture.
Contamination Control Strategy
This quality system should also includes a Contamination Control Strategy (CCS), which is a planned set of controls for microorganisms, pyrogens, and particulates, derived from current product and process understanding. It assures process performance and product quality and is based on thorough technical and process knowledge. It should be subject to continuous improvement and have (at least) an approach to your cleaning & disinfection strategy, environmental monitoring, and prevention of contamination.
It is now clear throughout the revised Annex 1 that Risk Assessment is at the forefront of the decision-making process. It is cited repeatedly throughout the document and is of the utmost importance when developing a strategy for a holistic approach to disinfection control.
If you like to know more about how these new Annex 1 updates affect your Quality Risk Management and Pharmaceutical Quality System, please contact us for further information.