With the release of ICH guidelines Q8, Q9, Q10 and Q11 since both annexes were initially written, the EMA is attempting to integrate these significant changes in the GMP environment into their guidance.
Annex 15, originally published in 2001, deals with process validation and the EMA notes the recent advancement in manufacturing technology through the introduction of Process Analytical Technology (PAT) and continuous manufacture concept. FDA and WHO guidance on process validation will be included in the revised EMA guidance.
The revised annex will focus specifically on continuous process verification for products subject to an “enhanced” approach to pharmaceutical development. The annex update comes as the EMA’s Quality Working Group is also updating its guideline on process validation. Work with the QWP will be supported by a rapporteur from the UK and support from experts from Ireland, Germany, Italy, Portugal and Canada.
Meanwhile, Annex 17, which was first written in 2002, deals with parametric release. ICH updates and a recent guideline from the EMA’s Quality Working Party on real time release testing need to be incorporated, according to the EMA.
Although the current guideline already states that the control of certain specific parameters may be used as an alternative to routine end-product testing of medicinal products, hence allowing the application of parametric release to any stage of manufacturing and to any type of products, detailed information is only provided for its application to terminally sterilised medicinal products. The main aim of the new guideline will be to facilitate the application of the concept to other processes, including the manufacture of biologics, active substances and intermediates.
A drafting group for Annex 17 will be established by GMP/GDP Inspectors Working group with a rapporteur from Italy and supporting experts from Ireland, the UK, Australia and the US.
Industry comments on the revisions of both annexes are due by the end of February. Both updated annexes are expected to be adopted by Oct. 2014.
Other upcoming GMP revisions from the EMA include:
• New text on change control in Chapter 1 of GMP guidance;
• Reviews of the implication of product quality reviews on validation activities;
• Ongoing revisions to the requirements for dedicated facilities in Chapters 3 and 5; and
• Revisions to Annex 11, which deals with computerized systems.