15/16 September 2020
On 10th February, the IMP Working Group within the European QP Association sent in their comments to the EU Commission for the Commission Delegated Regulation on GMP for IMPs.
The IMP Working Group appreciates the ongoing revision of GMP guidelines for IMPs in the context of implementation of the Clinical Trial Regulation. However, as many other stakeholders, the Working Group recommends to implement the new regulations as much as possible into the existing GMP guidance. Thus, it would be easily possible to even add newly developed GMP Guidance, e.g. for ATMPs (both commercial and IMP) through another Annex. In its comments, the group gives clear examples how this could be achieved.
The group also identified some lack of clarity between sponsor /manufacturer responsibility, for example some of the activities are usually under sponsor but have been placed under manufacturer ( e.g emergency blinding).
The group also expresses a concern about the validation expectations introduced in Art. 9 "Production" and suggest a new wording: "The manufacturer shall identify the process steps that ensure the safety of the subject and the reliability and robustness of the clinical trial data generated in the clinical trial. Those critical process steps shall be validated and regularly re-validated where appropriate".
To better reflect the limited process knowledge available during the development phase please, the groups asks to consider adding the following sentence to the paragraph taken from Annex 13:
(2) Good manufacturing practice as regards both medicinal products authorised to be placed on the market and IMPs are based on the same principles. .. "taking into account where relevant and appropriate the stage of development of the product. Procedures need to be flexible to provide for changes as knowledge of the process increases, and appropriate to the stage of development of the product".