EFPIA calls for more flexibility in EU GMP advice on qualification and validation

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has called for more flexibility in proposed revised European Union (EU) good manufacturing practice (GMP) guidance on qualification and validation. The Association thinks this would encourage the use of new technologies and methods going forward.

In its formal response to the European Commission, commenting on draft changes to the EU GMP guide, the EFPIA welcomed most of the reforms, but warned that 'some of the detail is too prescriptive to allow other established accepted methods, new methods or emerging technology to be fully utilised'. As a result, this qualification and validation annex should be 'written with a consideration of future trends and technologies'. For example, there could be more need in future to concurrently 'validate' products earlier in the lifecycle to benefit from adaptive licensing and releasing Phase II development products to small patient populations, the Association noted.

Also, the document’s detail 'may prevent other established accepted methods or new methods to be fully utilised', it warned, for example using direct surface measurement techniques rather than current swabbing and rinsing techniques.

Meanwhile, the European Generic medicines Association (EGA) said there should be more focus on the qualification of equipment and in line automated checking devices, rather than validating these processes.

'Today’s blister packaging lines offer many in line features that afford much more quality assurance than simply validating the process with a certain number of packed batches. Furthermore, determining the critical control points, through a formal risk assessment, within a blister packaging line is essential', it said.

The Association also proposed more guidance on validating and qualifying lubricant manufacture.

Companies also participated in the new guidance. For instance, Finland-based pharmaceutical company Orion wanted more detail on advice regarding the site transfer of legacy products and possible related marketing authorisation applications for variations regarding such medicines. The variation applicant and assessor should have a 'common understanding without need for additional questions and unnecessary additional variations', the company said.