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Audits of Contract Manufacturers
and Contract Labs

Regular audits at contract manufacturers and contract laboratories are an important tool in the supplier qualification process to ensure that GMP requirements are fulfilled. They are a necessary prerequisite for release of medicinal products to the market.
Contract Manufacturing Organizations (CMOs) usually specialize in one type of medicinal product (e.g., solid oral, liquid oral, semisolid, sterile forms) and/ or technique (e.g., soft capsules, aseptic filling/lyophilization, blow-fill-seal, etc.) and they normally have several customers with their marketing authorizations. Therefore, CMOs must not only work in accordance with general GMP-requirements but also in compliance with contractual requirements between contract giver and CMO and with the customer’s marketing authorization.
Our audits are systematic assessments of GMP compliance which are based on risks to the patients and regulatory compliance. Moreover, we customize the medicinal product audits based on your special requests, for instance to include follow-up of CAPAs from previous audits or review of certain complaints, deviations or changes. Plus, we assess compliance with the contractual requirements between contract giver and CMO.

Our auditors have experience working in a GMP-regulated environment of the pharmaceutical industry for examples as a Qualified Person, Quality Manager, Head of Production, Plant Manager, Validation Manager, or as inspectors of regulatory authorities. They also have extensive experience in the performance of audits. Our auditors are regularly trained in new requirements and GMP-trends and their performance is evaluated by us. blue inspection performs audits of oral, topical and sterile medicinal product manufacturers according to applicable audit criteria, e.g., EU GMP part I, and applicable annexes, for instance annex 1.

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Phone: +49 251 284 972 93
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+49 251 284 972 93
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