Cleaning procedures that are well-documented, understood by operators and consistently executed are critically important for manufacturing products that are free from contaminants. Contaminants can be introduced by carry-over (pharmaceutical products or APIs) from one production batch to the next, cleaning agents, microorganisms or by other materials e.g. air borne particles, raw materials. In short, cleaning is performed to remove product and non-product contaminating material. Cleaning processes must be validated utilizing validated analytical methods, i.e., methods that are practical, achievable and verifiable.
Validation includes documented evidence demonstrating that a process will consistently produce a product that meets predetermined specification and quality attributes. Cleaning validation is a documented evidence providing assurance that an equipment train and/or piece of equipment can be cleaned reliably and reproducibly to predetermined and acceptable limits. To assure audit readiness, cleaning programs and their effectiveness must be rigorously documented.
– PIC/S Guide to GMP for Medicinal Products; Annex 15 Qualification & Validation
When is Cleaning Validation required?
Cleaning validation procedures are required whenever there is a manufacturing change that could impact the potential for residue that needs to be removed from product contact surfaces. These changes include, but not limited to:
When is Cleaning Validation not required?
Cleaning validation procedures are not required when:
– Validation of Cleaning Processes, 7/93, FDA
However, FDA 21 CFR 211.67(a) requires that any equipment, including dedicated and multipurpose equipment, is “cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.”
What should a Cleaning Validation process include?
Cleaning validation is a systematic approach to ensure that the cleaning procedure is repeatable and reliable. The cleaning validation process requires series of documented evidence that includes, but not limited to:
What are the consequences of not adequately performing cleaning validation?
It is a global regulatory expectation to have an adequate cleaning validation program in place to ensure that the product is not contaminated by any objectionable residues that can compromise finished product safety, identity, strength, purity, and quality. The last five (5) years of regulatory inspection insights indicate that the cleaning validation related observations have been consistently in the top five findings. The cost to do cleaning validation right the first time is much lower than the cost of cleaning validation as part of regulatory remediation efforts. In extreme cases, the manufacturing site can be immediately shut down due to the lack of an adequate cleaning validation program in place.
How can Ecolab cleaning validation experts help you complete a successful validation?
Ecolab Life Sciences has a team of qualified and experienced technical subject matter experts (SMEs) dedicated to help customers with their cleaning validation needs. Ecolab technical SMEs are equipped with helping customers with either optimizing existing legacy cleaning validation programs or developing new programs. Additionally, the Ecolab technical team provides end-to-end cleaning validation support to ensure cleaning validation programs are safe, efficient and compliant.