A contamination control plan is one of the essential practices of cGMP. Having it in place is a prerequisite for a validated facility, because lack or absence of it is one of the primary reasons for the issuance of 483’s. Among these, the FDA cites lack of sterility assurance as the most important factor for 483’s. This is defined as the lack of ability on the part of the manufacturer to ensure and document sufficient protection to safeguard against unforeseen events. A contamination control plan has a description of the policies and procedures that go into manufacturing products under controlled conditions.
Where should it be included?
Since the contamination control plan covers all aspects of the facility; it is an indispensable part of the validation plan. The manufacturer’s master validation plan should have in it a proper, convincing and demonstrable contamination control plan. All the factors that go into maintaining the state of control of the validated facility, such as sanitization, cleaning and sporicide treatment should be clearly illustrated in the contamination control plan.
Which industries require a contamination control plan?
Traditionally, a contamination control plan is necessary in the regulated industries such as medical devices, pharmaceuticals, healthcare and diagnostics.
Which tools are important in a contamination control plan?
Root Cause Analysis and Failure Mode Evaluation Analysis (FMEA) are the important tools that are applied in drawing up a contamination control plan.
43337 Livermore Common | Fremont| CA | USA | 94539