News

In May, the FDA published a Draft Guidance for Industry and FDA Staff entitled "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". The document should … Read more here.

On 19 May 2011, the EMA published a "Concept Paper on the need for a guideline on process validation of medicinal products containing biotechnology derived proteins of active substances". For the EMA, it was necessary to develop a Guideline, ... read on 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. 

Concept Heidelberg regularly analyses the Warning Letters issued by the FDA. In the following, you will find a ranking based on the evolution of the Top 5 deviations in the FDA Warning Letters (regarding Medica Devices) issued between the years 2002 and 2010. On place 1 is … Read more here.