GMP News - Validation

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.

Since November 2008 there has been a draft for the revision of the old FDA Process Validation Guideline. On 25 January 2011 the FDA published the final version of this new Process Validation Guidance. Read more here.

Alongside validation, the (GMP-compliant) operation of computerised systems is also becoming an increasingly higher priority. A new GAMP Good Practice Guide gives comprehensive support on this matter. Read more here.