News

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.

More

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

20.06.2012

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.

More

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

13.06.2012

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.

More

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

11.04.2012

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.

More

International Collaboration on Good Manufacturing Practice Inspections expanded

04.04.2012

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.

More

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

14.03.2012

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.

More

New Version of ISO 19011 on Auditing published

12.01.2012

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.

More

New FDA and EMA Initiative allows mutual Recognition of Inspections

21.12.2011

A new EMA/FDA initiative should enable the authorities in the European Economic Area (EEA) and the US to rely on the results of inspections performed in each other's territories. Read more.

More

International Information Sharing is Impacting FDA Inspection and Enforcement Decision-Making

02.11.2011

As International Pharmaceutical Quality (IPQ) reports in its September issue, the growing information sharing around the globe has an increasing impact on the US Food & Drug Administration's (FDA) inspection decision-making and activities. Read more.

More

Summary of FDA 483 Inspectional Observations

20.10.2011

The U.S. Food and Drug Administration FDA is frequently publishing summaries of its inspection observations listed documented on an FDA Form 483. Read more.

More

Search