关于 GMP 原药料审计最新信息

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Article: GMP for Active Pharmaceutical Ingredients: judging the audit quality from the audit report

by Dr. Stefan Kettelhoit, blue inspection body GmbH, Münster

Manufacturing authorisation holders (MAHs) are obliged to ensure compliance with the Good Manufacturing Practices (GMP) throughout the complete process chain. Suppliers of active pharmaceutical ingredients (APIs) and other critical raw materials/excipients must be explicitly  qualified through on-site audits. The resulting audit report serves as objective evidence for the competent authority that the respective audit obligation has been fulfilled by the MAH and that the GMP compliance status has been declared based upon comprehensible observations. This article covers necessary requirements for API audit reports aiming to demonstrate that the GMP status of a supplier has been reasonably and comprehensibly assessed during the onsite audit. Based upon the EMEA "GMP Inspection Report - Community Format" a proposal has been developed for the unambiguous, understandable and most importantly complete coverage of audit contents in the audit report.

(in: Pharmind, issue 2/2010, 242-247)

 

Article: API Manufacturing: Complying with International GMP Regulations

in: PharmaAsia June-July 2009, S. 6-10.
Dr Stefan Kettelhoit, GM, blue inspection body

Asian Manufacturers of Active Pharmaceutical Ingredients (API) have to adhere to Good Manufacturing Practice (GMP) guidelines in order to penetrate Western markets.
The majority of medicinal products manufactured in Europe and the US contain Active Pharmaceutical Ingredients (APIs) and excipients which have been manufactured in Asia. In recent years, these active and inactive pharmaceutical ingredients have become increasingly available globally as trading goods. This has often resulted in the non-compliance of APIs with the predefined and specified quality standards, affecting the safety and the health of patients who consume products that contain such ingredients.

 

Article: Auditing / Qualification of Active Pharmaceutical Ingredient Manufacturers by Accredited Inspection Bodies

in: Pharm. Ind. 70, No. 12, 1459-1463 (2008)
Dr. Wolfgang Heisig, blue inspection body GmbH, Muenster, and Dr. Uwe Amschler, Schwentinental

Active ingredients for the production of medicinal products have to be manufact¬ured according to the principles of good manufacturing practice (GMP). The licence holder has to verify this on site. As only few active ingredients are produced in Europe today, a consider¬able burden is induced by this obligation for every single enterprise. During the last months the responsible competent authorities have intensified their focus in the direction of the controls actually being carried out.