EUGMP Guidelines

The European Union guidelines also describe cleaning validation in the following way:

1. Cleaning validation should be performed in order to confirm the effectiveness of a cleaning procedure. The rationale for selecting limits of carryover of product residues, cleaning agents, and microbial contamination should be logically based on the materials involved. The limits should be achievable and verifiable.

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2. Validated analytical methods with the sensitivity to detect residues or contaminants should be used.

3. The detection limit for each analytical method should be sufficiently sensitive to detect the established acceptable level of the residue or contaminant.

4. Normally only cleaning procedures for product-contact surfaces of the equipment need to be validated. Consideration should be given to no contact parts. The intervals between use and cleaning as well as cleaning and reuse should be validated. Cleaning intervals and methods should be determined.

5. For cleaning procedures for products and processes, which are similar, it is considered acceptable to select a representative range of similar products and processes. A single validation study utilizing a "worst-case" approach can be carried out, which takes account of critical issues.

6. Typically, three consecutive applications of the cleaning procedure should be performed and shown to be successful in order to prove that the method is validated.

The World Health Organization (WHO) also emphasizes on the validation program of cleaning procedures under clause 4.11 of Quality Assurance of Pharmaceuticals—A compendium of guidelines and related materials—volume 2 updated and revised edition— Good Manufacturing Practices and Inspection (WHO-2003)—in the following words:

It is of critical importance that particular attention is paid to the validation of analytical test methods, automated systems and cleaning procedures.

Looking into the clauses established by various authorities, cleaning validation can be defined as "A documented proof of consistent and effective cleaning of pharmaceutical or food systems or equipment to predetermined limits so as to prevent contaminants from leaving residues that may adulterate and adversely affect the safety and quality of the next product manufactured."

Cleaning validation projects are separately governed under protocols that reference background documentation relating to the rationale for "worst-case" testing, where this is proposed. The protocols further explain the development of acceptance criteria, including chemical and microbial specifications, limits of detection, and the selection of sampling methods.

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