News

The heads of the EU authorities for medicines are organised in a group called Heads of Medicines Agencies. In a meeting which took place in Dublin just recently, the Committee identified the need for GMP inspections to be conducted at API manufacturing sites by the 2nd of July 2013. Read more.

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India wants to open its first drug inspection office in Beijing, China on 01 March 2013. Read more.

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Many in the GMP environment haven't realised the consequences of the so-called Generic Drug User Fee Act (GDUFA) yet. The FDA has now published the exact fee rates for facility inspections. Read more here.

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The EU Commission has announced on 22 November 2012 that Switzerland has been listed as the first country with equivalent standards in the manufacture of active pharmaceutical ingedients (APIs) to those of the EU. Click here to read more

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The European Compliance Academy developed a so-called Good Practice Guide some years ago. It is a juxtaposition containing the requirements laid down in the EU GMP Guide, FDA's cGMP Guide and ISO 9001. Read more here.

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The Danish Medicines Agency offers some very helpful Question & Answer documents on their webpage. Please find the answer to this question here.

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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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