API inspection firm wins highest independence rating

By Gareth Macdonald

- Last updated on GMT

Related tags Good manufacturing practice European commission

Auditing firm blue inspection body (BIB) has achieved a type 'A'
independence rating under German accreditation organisation DAP's
scheme to certify the third-party inspection of active
pharmaceutical ingredient (API) manufacturers.

At present, API production is regulated at the finished drug product stage by the requirement that drugmakers use actives that are made in compliance with good manufacturing practice (GMP) standards. In practice, this means that pharmaceutical firms conduct their own audits of manufacturing facilities before signing supply contracts. In a recent report on moves to curb pharmaceutical counterfeiting, the European Commission (EC) said that this self-regulatory approach to API site inspection is not ideal due to the lack of independence. The Commission suggested that instead, mandatory third-party audits by accredited specialists would be a more effective way of stopping fake drug products entering the European market. The US Food and Drug Administration (FDA) is also considering setting up a certification system for third-party auditors as part of its "Beyond Our Borders" initiative. In a statement issued early last month, the agency said that with proper structuring such an approach would complement its regulatory activities. The FDA has recently been the subject of much criticism for its failure to inspect production facilities in China that were linked to the ongoing heparin contamination scandal. A third-party certification scheme would help ease the pressure on the agency to inspect plants worldwide, which is likely only to increase as the API supply chain continues to expand. Expanding CMO sector boosting demand for audits ​ As BIB managing director Stefan Kettelhoit told in-PharmaTechnologist.com, the award entitles the firm to conduct "inspections of excipient and active pharmaceutical ingredient manufacturers for pharmaceutical products to ensure that they conform to international GMP rules​. " Dr Kettelhoit explained that in order to obtain the ISO17020 type A rating, which had only previously been received by Switzerland's SwissMedic, BIB had been required to demonstrate its complete independence and ensure that its inspectors do not engage in any activities that may conflict with the integrity of their work. He predicted that there will be "increased demand for independent, qualified third party auditing​," in the next five years as pharmaceutical firms have neither the resources nor expertise to properly inspect API manufacturing sites. Dr Kettelhoit also suggested that the booming contract manufacturing and outsourcing sectors, coupled with growing concerns about counterfeit drug products would see pharmaceutical firms increasingly turn to accredited inspection companies to help guarantee the quality of their ingredients.

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