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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.