In August 2022, the revised EU GMP Annex 1 was unveiled, introducing new guidelines to ensure the highest quality standards in sterile pharmaceutical manufacturing. The Contamination Control Strategy (CCS) plays a vital role in this framework, encompassing critical control points and assessing the efficacy of control and monitoring measures throughout the manufacturing process. Evaluating the effectiveness of these measures requires a holistic approach, considering the entire process flow through comprehensive risk assessment studies.
This article aims to uncover the obstacles faced by pharmaceutical companies in achieving compliance with the revised EU GMP Annex 1 while also exploring the intricacies of designing and implementing a contamination control strategy, emphasizing the importance of expertise and gathering diverse information.
By shedding light on these complexities, the article aims to assist pharmaceutical companies in navigating the path toward developing an effective and compliant Contamination Control Strategy, ultimately facilitating the attainment of the highest quality standards for their sterile products.