News IPEC-Americas "Distributors Audit Guide" for Pharmaceutical Excipients

IPEC Americas has published a new Distributors Audit Guide. The document was developped to support audits of API suppliers and their supply chain. European standards from the "Good Distribution Practices" and from the WHO were taken over. Read more here


New Compilation of Community Procedures on Inspections and Exchange of Information

EMA has updated the Compilation of Community Procedures on Inspections and Exchange of Information, a tool for facilitating co-operation between the GMP inspectorates of the EU Member States. Read more.


Production of WFI through Membrane Processes: Survey Results

Through a survey we asked the GMP Newsletter readers whether a change of the European Pharmacopoeia concerning the approval of membrane processes for the production of WFI would be interesting. You can find the results of the survey here.


Results of Survey on EU GMP Guide Revisions of Chapter 5 (Production) and 7 (Contract Manufacture and Analysis)

At the end of last year, drafts about the changes of Chapter 7 (Contract Manufacture and Analysis) and Chapter 5 (Production) of the EU GMP Guide have been published. With regard of these changes, the European Compliance Academy (ECA) conducted a survey. The results were sent to the EMA too and - maybe - influence the final versions. Read more about the results of the survey here


FDA Warning Letter Statistics 2010 regarding Process Validation and Qualification

In Warning Letter evaluation, the topic of process validation/qualification is not frequently observed since it is not an independent item of the cGMP Guide (21 CFR 210/211). In the following, you will find an evaluation of the Warning Letters 2010 on GMP deviations in regard to process validation and qualification in the manufacturing environment. Read more here.


Requirements on Validation of Sterilisation Procedures according to ISO 17665-1

Qualification of a steriliser and validation of sterilisation procedures are essential GMP requirements for the manufacture of sterile medicinal products. Requirements on these topics can be found in the pharmacopoeia and in Annex 1 of the EU GMP Guide. However, there are no further executive regulations. In case of sterilisation procedure using moist heat, the EN ISO 17655-1 standard can be helpful. Read more here. 


Surveillance of Medicinal Products- Annual Report of the German Federal States

In February, the German Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) published its annual report on inspections. Read more here.


China's new GMP Regulation effective since March 1, 2011

The State Food and Drug Administration of China (SFDA) published a revised version of the GMP regulation. This new version came into force just recently, on 1st March 2011. Read more here.


Amended Directive 2001/83/EC includes stronger Guidance on GMP for APIs and Excipients

The amendmends to the directive 2001/83/EC regarding the prevention of the entry of falsified medicinal products into the legal supply chain were adopted by the EU Parliament on 15 February. These amendments will affect many central fields of drugs manufacturing. As a consequence, the GMP regulations for pharmaceutical APIs and exicpients are going to be tightened. Read more.


FDA: Applications to contain Information described by ICH Q8

As part of its Manual of Policies and Procedures, FDA's CDER has published a document called "Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review". Read more about the expectations.


EMA plans on focusing more on API Manufacturers located in Asia

The EMA reacts on the fact that the manufacturing of APIs is moving to areas outside the EU, especially to Asia (mainly China and India). Read more here.


FDA focuses more on Supplier Qualification

Compliance of suppliers and the challenges in all stages of purchasing, manufacturing and distribution is getting more and more in the focus of inspectorates. Read more.


New FDA Guidance Documents in Calendar Year 2011

On January 26, 2011 the FDA issued the Guidance Agenda: New & Revised Draft Guidances CDER plans on publishing during the calendar year 2011. Click here to read more.


Quality Agreement templates for every Participant of the 4th European GMP-Conference

All delegates of the 4th European GMP Conference on 19/20 May 2011 in Heidelberg will receive sample contracts on quality agreements for contract manufacturing, for contract analytics, for... Read more here.


FDA and EMA Pilot Program for joint Review of QbD Components of new Drug Marketing Applications

The Food & Drug Administration (FDA) and the European Medicines Agency (EMA) will launch a collaborative Quality by Design (QbD) Application Review Pilot. Read more.


EMA plans extensive Revision of the EU GMP Guide

At the beginning at this year, the European Medicines Agency (EMA) published the Work Plan for GMP/GDP (Good Manufacturing Practice/Good Distribution Practice) Inspectors Working Group. This document provides a good overview of the changes upcoming in the GMP/GDP environment - and it might come to a lot of changes. Read more here.


Inspection of API manufacturers: First Results of the WHO Pre-Qualification Programme

Within the framework of its pre-qualification programme of APIs, the WHO has published detailed results about the inspections performed at API manufacturing sites. Information about the GMP deviations found as well as further interesting facts can be found here.


"Impurities: Guideline for Residual Solvents Q3C(R5)" has been finalised

Because of recent investigations on toxicity of Isopropylbenzene (Cumene), there was a need to assign this solvent to the higher Class. Consequently, the ICH Guideline Q3C(R4) had to be revised once more. The final document is now available. You can find out more here.


Aide memoire of German Inspectors now also available in English

All the participants of the 4th European GMP Conference scheduled in Heidelberg on 19/20 May 2011 will receive the English version of the inspectors' guide (Aide memoire) on Qualification/Validation. Read more here.


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