Industry groups take issue with guidance on outsourcing facilities

FDA Inspection - Magnifying glass over FDA investigator badge“GPhA says compounders and outsourcing facilities should abide by the same inspection criteria as other drug manufacturers. “Drug manufacturers with U.S-based facilities are required to be inspected by FDA at least every 24 months,” GPhA says. “Compounders producing sterile products should be held to similar standards.”

Similarly, BIO disagrees with FDA’s proposed alternative approaches for reducing the need for laboratory testing of incoming components and to minimize the need for facilities to have an in-house laboratory.

“We believe that the alternative approach to testing should not be permitted exclusively for outsourcing facilities,” BIO says. “These sites should be accountable for maintaining the same level of control over their contract sites as would any other pharmaceutical manufacturer.””

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