Navigating the complexities of a contamination control program

Recent revisions to Annex 1 for the manufacture of sterile products and an inclusive contamination control strategy reinforce the importance of having modern quality management systems (QMS). Together with ICHQ10 that describes what an effective QMS looks like, there is greater emphasis on quality risk management principles. But what are the key elements to consider in meeting the quality system requirements detailed in ICHQ10 and current Annex 1 for a contamination control program (CCP)? What makes it robust? And what is required to keep it current? These are all valid questions, and key to ensuring your CCP is robust is assembling a multidisciplinary team to identify and evaluate the risk of microbiological, particulate, chemical and/or cross-product contamination to your product. Each person in the team brings a functional perspective of contamination potential based on expertise on how things “actually work” within the discipline. All manufacturing facilities are responsible for delivering a safe and effective product.  Contamination Control concerns are not limited to sterile products. Clear regulatory guidance is available on the need for control of contamination during drug processing and manufacture of sterile drugs, however, the requirements for how to evaluate contamination potential in a non-sterile manufacturing environment are less clear. A contamination control strategy (CCS) provides a summary of the procedures and practices utilized for ensuring contamination control i.e., commissioning, qualification and validation. The CCS should also detail how contamination levels are monitored for effectiveness.  Pre-set alerts and alarms should be put in place to monitor contamination potentials and drive actions to minimize the impact to patients and supply. All the elements of facility design, process design, automation, quality management, qualification/validation and monitoring must be combined and structured into an overall coherent contamination control plan. The plan should be founded on a sound cross-functional assessment of potential contamination with a risk-based approach to the actual operations and identification of current controls. Actions for improvement are included in the plan, as well as a formal lifecycle approach to revise the controls based on changes to operations or non-conformance issues. Do you need help in conducting an assessment, creating a Contamination Control Plan or integrating the plan into your overall QMS strategy?