Quality guidelines

The International Conference on Harmonisation (ICH) held the latest meeting of its steering groups and expert committees on 17-18 November in Yokohama and made significant progress in relation to development of drafts of two major quality guidelines. These are guidelines Q8 on Product Development and Q9 on Pharmaceutical Manufacturing Risk Assessment.

The latter reached Step 2 of the ICH process and is now in Step 3, which makes it available for public comment via the regional regulatory authorities (MHW, FDA and EMEA). The proposed document on Pharmaceutical Manufacturing Risk Assessment is expected to reach Step 2 at the next meeting of the steering committee in Brussels in the spring and will, I hope, be available for public comment after that.

Also in the quality arena Guideline Q5E on Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process reached Step 4, which is adoption as an ICH guideline. This will now move on to adoption by regulatory authorities in the ICH regions.

Throughout the life of ICH, work has been ongoing in the Pharmacopoeia Discussion Group (PDG) on developing Q4B. This is a proposal for Regulatory Acceptance of Pharmacopoeial Interchange-ability, which seeks to facilitate the regulatory acceptance of PDG harmonised texts in the three ICH Regions. It is hoped that there may be progress on this topic during this year.

ABPI is very active in the ICH arena and has had significant input over the years to the numerous guidelines that have evolved. We will continue this involvement over the coming year and I will keep you updated through this column.