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We are often consulted about the acceptance of GMP audits of API manufacturers. The point is that more and more organisations offer such audits. What is essential to pay attention to? More details can be found here.

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In 2010 the European QP Association initiated the shared audits database "QPSHARE". With this database the Association wants to support European QPs in identifying suppliers other QPs are possibly interested in as well - and that way facilitates sharing audits. Read more.

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In May 2012 and in July 2012 the European Medicines Agency (EMA) revised the Compilation of Community Procedures on Inspections and Exchange of Information. Read more here.

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The API Compliance Institute co-ordinates so called Third Party Audits. On behalf of one or several QPs, GMP audits are performed at API manufacturers. Some audits are made available for companies who were not involved in the initial sponsoring of the audit. These GMP audits are called shared audits. Please find more information about the latest Shared Audit.

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In its annual report 2011, the European Medicines Agency (EMA) reported about the number of inspections performed in that year. Go here to read more.

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In the light of recent events, the EMA has updated its "Compilation of Community Procedures on Inspections and Exchange of Information". Some documents concerning GDP have been added to this compilation of procedures which is not only interesting for inspectors. For more information read here.

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The API Compliance Institute recently performed Third Party GMP Audits at two API manufacturing sites in Germany. The Audits were initiated by a group of Qualified Persons and QA Managers from different pharmaceutical companies who are using the respective APIs to manufacture their medicinal products. Please read more here.

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The PIC/S has recently published an Aide-Memoire for GMP inspectors on inspections of quality risk management (QRM) systems that became effective on 2 April 2012. Read more here.

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The ongoing collaboration on good manufacturing practice (GMP) inspections of active substance manufacturers between the European Medicines Agency and its international partners is to be expanded. Read more.

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The international programme on cooperation on GMP inspections of API manufacturers by regulatory authorities should be continued and extended. The EMA has published a document which defines the rules for collaborations and information sharing between the authorities. Read more here.

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