Some common FDA 483 citations pertaining to cleaning validation are regarding consistency in monitoring of cleaning and the complete documentation of cleaning. It is critical to implement a robust monitoring process that is supported by detailed documentation. Ensuring that the SOPs for all aspects of cleaning are clear, detailed, and contain illustrations (where appropriate) to ensure that difficult-to-clean areas are not missed is critical to their successful implementation. In addition, enforcing the use of checklists supported by documented evidence of completed tasks is critical to ensuring that product quality is retained throughout the manufacturing process.
Execution of a successful cleaning validation program requires close collaboration between Technical Services (or the developer of the per product cleaning process and validation/verification protocols and reports), Production (which executes the cleaning per procedure and swabs surfaces/collects rinsate according to preestablished techniques), and Laboratory (which develops cleaning analytical test methods and executes testing). Skilled and knowledgeable staff are needed to effectively implement and recognize potential issues with the cleaning process. Clear and understandable documentation is essential to this communication between functional areas. Effective cleaning programs prevent cross-contamination, which preserves the integrity of the manufacturing process and, ultimately, protects the consumer from potential harm.
If your firm is struggling to establish any element of an appropriate cleaning validation program, Lachman can help! Reach out to us at LCS@LachmanConsultants.com for a free consultation.
