GMP News - Inspections/Audits

13.02.13

Up to $190.389 for FDA's New Inspections Fees

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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12.12.12

Swiss GMP standards and inspection equivalent to EU

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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10.10.12

GMP Matrix as Standard for Audits in many Companies

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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10.10.12

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

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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04.10.12

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

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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04.10.12

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

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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29.08.12

New Templates for GMP and GDP certificates published by EMA

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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01.08.12

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

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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25.07.12

More GMP Inspections by EMA due to Increasing Quality Issues

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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20.06.12

EMA updates "Compilation of Community Procedures on Inspections and Exchange of Information"

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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13.06.12

Two Third Party GMP Audits performed in Germany by API Compliance Institute

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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11.04.12

PIC/S publishes Aide-Memoire on Inspection of Risk Management Systems

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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04.04.12

International Collaboration on Good Manufacturing Practice Inspections expanded

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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14.03.12

Regulatory Monitoring of API Manufacturers - FDA, TGA, EMA and EDQM express Common Objectives for Inspections Collaboration

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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12.01.12

New Version of ISO 19011 on Auditing published

ISO has published an updated edition of the ISO 19011 auditing standard. ISO 19011:2011 provides guidance on the conduct of internal or external management system audits, as well as on the management of audit programmes. You will find more information here.

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