When it comes to cleaning validation for pharmaceutical manufacturing equipment, having proper scientific justification for your clean and dirty hold times is critical. FDA expects firms to provide a robust rationale with real-world data to support the hold times used between cleaning and production.
A company recently received a 483 for failing to provide sufficient evidence to justify clean and dirty hold times. The 483 reads:
….. Written procedures are not established, followed, and validated for describing the cleaning schedules, methods, equipment, and materials to be used in cleaning equipment arid its subsequent release for use in the manufacture of intermediates and APIs.
c. You failed to provide a rationale and scientifically justify clean and dirty hold times for equipment, such as, non-dedicated critical equipment like the … and … used in the manufacture of intermediates and APIs.
As per 21 CFR 211.67, written procedures must be established and followed for cleaning and maintenance of equipment used in drug manufacturing. This includes detailed descriptions of the methods, equipment, and materials used as well as disassembly and reassembly for proper cleaning.
An area that is often overlooked by companies is the ancillary equipment such as scoops, hoses, and thief samplers. These could have persistent residues and be a source of cross contamination. Validating the cleaning of these equipment pieces is a critical piece of a sound compliance and quality system.
FDA expects company protocols should test extreme scenarios in validating clean and dirty hold times to ensure no cross-contamination occurs even under the most unique and arbitrary conditions.
Using scientific data and studies, always provide a rationale for why specified clean and dirty hold times are appropriate for preventing carryover between product runs on the same equipment lines.
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