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Does equipment need to be clean enough to meet limits based on the most sensitive possible methods of residue detection or quantification?

915 viewsOctober 10, 2022DrugsPharmaceutical
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Sam Smith11.38K January 1, 2021 0 Comments

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Blogolu28.38K Posted January 1, 2021 0 Comments

No. CGMPs require that equipment be 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). The preamble to the CGMP regulations (see 43 FR 45014) indicates that this phrase was added because absolute cleanliness for multiuse equipment is neither valuable nor feasible in many circumstances. The degree of cleanliness needed, therefore, cannot depend on the method of detection because improvements in method sensitivity would necessitate ever-lower limits and ever-increasing wash cycles. Equipment should be as clean as can be reasonably achieved to a residue limit that is documented to be safe, causes no product quality concerns, and leaves no visible residues. Contamination that is reasonably avoidable and removable is never considered acceptable.

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