Top 7 Mistakes in selecting Equipment Sampling Locations

The purpose of an effective equipment cleaning program is to ensure that the equipment are cleaned to prevent contamination that “would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements” (see 21 CFR 211.67). This requires the pharma companies to collect and analyse the residue post cleaning of equipment and prove that the residues are effectively removed.

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Hence, the selection of the Sampling Locations (“hard to clean locations”) shall be done via a formal risk assessment. In this Micro Article, we would be discussing the top 7 of the most common mistakes that pharma companies make while deciding which equipment locations need to be sampled post-cleaning.