GMP News - Quality Assurance

The insufficient investigation of deviations in the production process by the quality unit is the most frequent deficiency in the warning letters of fiscal year 09. Here you can read more on this topic.

The new draft by the EC Commission to create a Site Master File concerns all pharmaceutical enterprises. The Site Master File is the basis with which the supervisory authorities prepare for a GMP inspection. Here you can read more about the planned changes.

PIC/S published in the beginning of January a 30-page document as an example of a methodology for the implementation of Quality Risk Management (QRM) in pharmaceutical industry. Read more about this document here.

On 4 January, the European Commission published a proposal for Part 3 to the EC GMP Guide. Part 1 concerning medicinal products and Part 2 for active pharmaceutical ingredients already exist. Part 3 now includes requirements on a Site Master File. Here you can read more.