EMEA proposing to review EU guidance on outsourcing

Outsourcing of manufacturing and analytical activities has been a fact of pharmaceutical life for many years and guidance on it has been an element of GMP Guidelines for much of that time. But recent years have seen an extension of contract services into other areas that might previously have been seen solely as in-house activities.

The EMEA has now recognised this and in a recently issued concept paper on outsourcing has outlined plans to review the current EU GMP Guide Chapter 7 - Contract Manufacture and Analysis.

In its paper EMEA acknowledges that the existing guiding principles in Chapter 7 are clearly extendable to these outsourced activities, but states that there is no explicit, unambiguous guidance as to whether such activities are inside or outside the scope of GMP guidance.

Some of the specific areas for consideration are qualification and validation work for new premises, assessment and sourcing of starting and packaging materials, artwork generation and print ready material and hosting of IT functions.

In addition EMEA notes that during the review of Chapters 1 and 2 of the GMP Guide (Quality Management and Personnel, respectively) to align them with ICH Guideline Q10 on Pharmaceutical Quality System, a number of amendments have been proposed that impinge on key principles applicable to outsourced activities. These have also added to the need for a review of Chapter 7.

It is proposed that in the coming months the GMP/GDP Inspectors" Working Group will develop a draft revision with a view to initiating consultation on a revised draft in September 2010, hopefully leading to adoption of amended Chapter 7 by September 2011. Comments on the current paper are invited until the end of January 2010.