GMP News - Quality Assurance

17.10.12

Handling of Deviations and CAPA criticised by Inspectorates

Deviations and CAPA remain hot topics in inspections. The inspectorates' summaries of their observations show that things do not always work as desired. Read more.

more

26.09.12

EU: new Delegated Act on Shipments of Medicinal Products through EU

The  European Commission has published a draft Delegated Act concerning a new requirement of the Falsified Medicines Directive under which medicinal products being shipped through the EU. Read more.

more

19.09.12

The new EU GMP Guide Annex 2 - a brief Content Summary

On 31 January 2013 the new Annex 2 of the EU GMP Guide becomes effective. In comparison to the version valid so far the new version has clearly increased in terms of volume and content. This is also due to the fact that it now takes into consideration the development of new types of biological medicines. Read more.

more

19.09.12

cGMP: SOP Management and Training criticised by FDA

Reviewing FDA's warning letters of the last fiscal year reveals that incompleteness, management and training of Standard Operating Procedures (SOPs) is still a hot topic. Read more.

more

12.09.12

Finally published: new EU GMP Chapter 7 on Outsourced Activities

Chapter 7 of the EU GMP Guide "Contract Manufacture and Analysis" has also been revised, and the European Commission recently issued the final version. Read more.

more

12.09.12

Finally published: new EU GMP Chapter 1 with comprehensive Changes

The European Commission has published the final version of the revised Chapter 1 of the EU GMP Guide, which will now be called "Pharmaceutical Quality System". It includes comprehensive changes. Read more.

more

12.09.12

GMP Guideline Annex 2 revised

The Europen Commission announced the revised Annex 2 of the EU GMP Guide as one of the major developments of the GMP regulations. Read mor here.

more

12.09.12

ICH Q8, Q9, & Q10 Questions and Answers - now also in force in the USA

The FDA has put into effect the ICH document with points to consider covering topics relevant to ICH Q8, Q9 and Q 10 in July 2012. This guideline is intended to provide clarity to both industry and regulators and to facilitate the preparation, assessment, and inspection related to QbD-applications filed for marketing authorisations. Get the complete news.

more

14.08.12

FDA issued 8 Warning Letters to Companies because of Missing Establishment Registration

Within 5 months, the FDA has issued 8 Warning Letters to companies who failed to comply with the obligation to register production establishments. Read more here.

more

11.07.12

FDA - S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

The US Food & Drug Administration (FDA) published two Guidances for Industry with regard to Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. Find more details here.

more

04.07.12

MHRA publishes GMP Deficiency Data Review April 2011 - March 2012

In April, the Medicines and Healthcare products Regulatory Agency (MHRA), UK, issued a review of the main GMP deficiencies for the period from April 2011 to March 2012. More details can be found here.

more

13.06.12

News PIC/S Structure

In its latest press release, the Pharmaceutical Inspection Co-operation Scheme PIC/S highlighted the outcome of its last Committee Meeting. What are the main news? Read more.

more

13.06.12

FDA starts Voluntary Audit Report Program for Medical Devices

On 5 June 2012, the FDA has begun a "voluntary program" for medical devices audits entitled "Medical Devices ISO 13485:2003 Voluntary Audit Report Submission Pilot Program" - based on ISO 13485:2003. The purpose is to extend FDA's inspection intervals. Read more.

more

06.06.12

Half-year Report 2012: FDA Medical Devices Warning Letter Statistics

We regularly analyse the Warning Letters issued by the FDA. The following information presents the current evolution of the Top 5 hit list - with regard to medical devices - for the first half of the fiscal year 2012 (from 1st October 2011 to 15 March 2012). Read more.

more

06.06.12

EMA: Practical Guidance on Implementation of Pharmacovigilance Legislation published

The European Medicines Agency has published a set of questions and answers concerning the initial phases of the operation of the new pharmacovigilance legislation. Read more.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics