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
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.