For Suppliers, cGMP Compliance Not Always Stated, But Expected
The quality of any material that goes into a medicinal product remains the manufacturer’s responsibility. From the perspective of the FDA and other countries’ regulators, audits are one good way to reinforce confidence in suppliers. What’s more, the FDA doesn’t look too kindly on manufacturers that don’t have in place a qualification program. During an inspection, when an auditor asks about a qualification program, savvy manufacturers should be sure that they indeed have one in place.
Auditing suppliers is not explicitly required under 21 CFR Parts 210 or 211, the current good manufacturing practice (cGMP) regulations for drugmakers. However, section 211.84(b) states that testing or examination of components “should be based upon appropriate criteria such as ... the past quality history of the supplier ….” Other items in the regulation say that manufacturers must establish the reliability of a supplier’s test results through appropriate validation of those results.
Section 211.84(d)(2) says each component of a drug must be tested for adherence to written specifications for purity, strength and quality. Manufacturers of the finished product may use a supplier’s report of analysis, but only if it has “established the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals.”
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