Update Annex 1: Manufacture of Sterile Medicinal Products
Key criteria to be considered
The approval of the draft of Annex 1 Manufacture of sterile medicines seems to be getting closer every day. Since its issuance in 1989 has undergone some modifications, however, it had not been revised in its entirety.
The latest version in force is from 2009. The second draft of February 2020 is the one that is expected to be approved soon.
The objective of this new version is to facilitate the implementation of ICH Q9 and Q10 principles, expand and update concepts, technologies and processes not covered and clarify ambiguous areas due to the age of the document.
A new requirement, the contamination control strategy (CCS), is detailed. The CCS is a document that must define all the critical points of the process, the controls carried out, their effectiveness and the monitoring measures to control all the risks associated with product contamination, allowing us to assess whether the risk management process is adequate, as well as the implementation of the new measures established. The final objective is to define the requirements to minimize the risk of microbiological contamination, by particles and pyrogens in sterile products.
New concepts have been introduced in the scope and first sections. It is a guideline for sterile drugs, but some principles such as Contamination Control Strategy, room qualification and classification, monitoring and clothing can be used for other types of non-sterile products. It is the usual widespread practice, but it was not reflected in the regulations currently in force.
Furthermore, new sections are added (pharmaceutical quality system, water, steam, compressed gases, freeze-drying, FFS, closed and single-use systems, and Glossary) and more details are given of existing requirements (sterilization, aseptic process simulation, continuous monitoring, sterilizing filtration, filter integrity, container integrity, extractables and leachables etc.).