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, which leads to increased safety and quality of pharmaceutical products and defines clear requirements that meet regulatory standards.
The requirement to minimise the risk of contamination has long been part of the GMP regulations. The contamination control strategy in accordance with Annex 1 is therefore the logical continuation of this concept, or rather the necessary extension for application to the manufacture of sterile pharmaceutical products.
By implementing this strategy, companies can ensure that their planning and production practices comply with regulatory requirements.
The application of quality risk management (QRM) principles is an essential part of this from planning to routine operation, whereby the potential for contamination in aseptic production is identified with the help of appropriate risk analyses and essential control measures are established.