Muenster (DE), 28. Februar 2011. The blue inspection body GmbH welcomes the planned changes to the “Production” chapter 5 of the EU GMP guideline for medicinal products. Besides other things, the manufacturers of medicinal products shall be pledged to frequently re-audit their active pharmaceutical ingredient (API) suppliers. The same applies to suppliers of certain excipients. The findings from audits shall be documented, and the respective audit reports shall be available for review by inspectors. “It is the aim of such re-audits to ensure GMP compliance throughout the entire supply chain by starting already with the API supplier”, explains Dr. Stefan Kettelhoit from blue inspection body GmbH (www.blue-inspection.com): “The changed wording of the guideline results in a better understanding and improved legal certainty.”

So far, these requirements have been concealed in the regulatory statutes of the competent authorities, which constantly led to discussions, comments Dr. Stefan Kettelhoit. A few days ago quite similar requirements have been fixed with the so called “Pharma-package” regulations. The obligation to perform audits at the premises of API and excipients manufacturers will be contained in article 46(f) of the amended directive 2001/83/EG for medicinal products.

The blue inspection body conducts Good Manufacturing Practice (GMP) audits globally on behalf of pharmaceutical manufacturers. As the first Third-Party-Auditor in the EC the company gained the accreditation according to ISO/IEC standard 17020 within the scope ‘Inspection of excipient and active pharmaceutical ingredient manufacturers for pharmaceutical products and determination of the conformance with international GMP rules’ in 2008.

The deadline for public consultation of the revised chapter 5 of the “Good Manufacturing Practice Medicinal Products for Human and Veterinary Use” is February 28th, 2011. The proposed changes of the GMP guideline contain new standards for the qualification of suppliers (5.25 and 5.26), the supply chain traceability (5.26 and 5.27) and harmonized requirements concerning the tests for APIs and excipients (5.31). Additional changes are attempted to decrease the risk of cross contaminations (5.19) during production.

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