Sterile drug manufacturers should start preparing a gap analysis to identify what needs to be done to comply with the EU’s GMP Annex 1 revision to prepare for when these new requirements take effect on 25 August 2023, said experts who spoke to Regulatory Focus.
They should also start preparing a contamination control strategy (CCS), a high-level document that addresses how manufactures plan to address and mitigate the risk of contamination to the quality of the products.
The experts also cited improvements in the revision, such as better differentiation between restricted access barrier systems (RABS) and isolators yet said that the requirement for manufacturers to test filters remains problematic…
