Your Contamination Control Strategy: 5 Things to Consider
The revised Annex 1 guidelines for good manufacturing practices (GMP) went into effect on August 25, 2023. As of May 2024, the contamination control industry has had over six months to implement changes to Annex 1 as part of a comprehensive contamination control strategy (CCS).
Organizations are in the process of evaluating their CCS protocols based on these updated requirements and questions:
- Is our CCS complete?
- Is our strategy sound, but execution lacking?
- Does our strategy fully consider foundational elements and their impact on contamination?
CCS Objectives and Focus
The three main objectives of a CCS include:
- Identifying which control elements are in place
- Evaluating why control elements are effective
- Controlling potential contamination throughout the manufacturing process
Begin with these basic considerations when developing or reviewing your CCS for gaps:
- Plant: Design, process, and associated documentation
- Equipment: Qualified life cycles
- Personnel: Awareness, training, and qualification
- Facility/Utilities: Cleanroom design and specifications
- Raw Materials: In-process and other controls
Consulting with Micronova/ICS
Partnering with an expert who specializes in contamination control is one way to develop a successful CCS. For larger organizations, a consultant can offer collaboration while helping you establish protocols for your unique sites and processes. Smaller organizations can also obtain the individualized support needed to implement an effective CCS.
Micronova’s consulting process is conducted in three phases:
Risk Assessment
Accurate identification and evaluation of current control protocols and all GxP processes is crucial during this initial phase. Companies receive a comprehensive report of risk factors within processes, facilities, personnel, equipment, SOPs, training, and materials. This phase includes a proposed plan for preventive and corrective actions, plus detailed activities to foster a successful strategy. We’ll determine which processes can be retained, advise targeted modifications, and recommend new equipment or technology to achieve the required levels of control.
Implementation
Implementing new strategies requires appropriate and individualized milestones tailored to each organization and its specific processes. Updating, modifying, or creating new SOPs and other QMS-related processes is critical during this phase. Our team of experts provides effective planning and CCS execution.
Training
A successful implementation process depends on training personnel following processes effectively and increasing their knowledge of and confidence in the organization. Micronova/ICS creates a tailor-made approach to help you achieve the best results for the short and long term.
Our goal is to help you implement established protocols and discover new and innovative processes by applying 40 years of industry knowledge. Partner with Micronova/ICS to discover and implement traditional and innovative processes to make your company more efficient and effective.
