Lucile Roger Durieux | 28 April 2014 | Chapter 6 (Part 1) of GMP incorporates transfers of test methods Amendment of Chapter 6 of GMP : Quality control of European Guide to come into effect in the autumn. The European Commission has announced an amendment to Chapter 6 : Quality Control of the EU Guidelines… Read more »
Author: Justine Dubois
The revision of Annex 15
Qualification and validation by public consultation Annex 15 : Qualification and validation of the European Guide to Good Manufacturing Practice (EU GMP) is being revised. On 6 February the European Commission launched the public consultation phase for the draft text. The actors concerned have until 31 May 2014 to comment on the document. This first… Read more »
Revised PIC/S PE 010
Revised PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments. Geneva, 31 January 2014: the PIC/S Committee has adopted by written procedure the revision of the PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010-4), which includes a new Annex 3 on radiopharmaceuticals…. Read more »
Review of chapter 2 of the GMP (part 1) relating to personnel
The changes are designed to incorporate the quality principles described in ICH Q10 The deadline for the new review of chapter 2 of part of the European Good Manufacturing Practices Guide (EU GMP) relating to personnel to come into force is 16 February. The changes need to incorporate the principles of the “pharmaceutical quality system” as… Read more »
Contaminated bags
A laboratory inspection reveals instances of non-compliance to GMPs Bastien Cany | 9 January 2014 | The Marette laboratory is based at the premises of this pharmacy in Courseulles-sur-mer (c) Pyc. The health and safety decision regarding the Marette laboratory describes a number of deviations from the provisions of guideline 1 of the Good Manufacturing… Read more »
New filling line Lilly laboratory in Fegersheim
Lucile Roger Durieux | 6 november 2013 | The structure, which includes more than 5000 m², should be operational at the end of 2016. The LilLy laboratories have laid, on thuesday 5th november, the foundation stone of a brand production line for insulin cartridges. This high speed filling line will be located at the largest… Read more »
Creation of the Pierre-Gilles de Gennes institute dedicated to microfluidics
Lucile Roger Durieux | 7 novembre 2013 | The Graduate School of Industrial Physics and Chemistry of the city of Paris (ESPCI), should start in January 2014, the construction of a center dedicated to microfluidics and its applications. The Institute Pierre-Gilles de Gennes (IPGG) will host multidisciplinary research teams (chemists, physicists, biologists and biophysicists) organized… Read more »
Air Liquide sells Laboratoires Anios
The group intends to focus development of its hygiene sector business on its subsidiary Schülke. Air Liquide confirmed on 9 October that it wished to sell its 66% stake in Laboratoires Anios. The group intends to focus the development of its hygiene sector business on its wholly owned subsidiary Schülke. With 700 employees and revenues… Read more »