News

India opens Drug Inspection Office in China

20.02.2013

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

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Up to $190.389 for FDA's New Inspections Fees

13.02.2013

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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Swiss GMP standards and inspection equivalent to EU

12.12.2012

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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GMP Matrix as Standard for Audits in many Companies

10.10.2012

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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What are the consequences if an API manufacturer has not been audited?

10.10.2012

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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Which Types of Third Party GMP Audits may be used - which not?

04.10.2012

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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Qualified Person Association Database for Shared Audits "QPSHARE" comprises 284 API and Excipient Suppliers

04.10.2012

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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New Templates for GMP and GDP certificates published by EMA

29.08.2012

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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Another Third Party GMP Audit performed in Germany by API Compliance Institute

01.08.2012

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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More GMP Inspections by EMA due to Increasing Quality Issues

25.07.2012

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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