Le projet de révision de l’Annexe 1 est en consultation publique depuis le 20 décembre 2017.
En révision, le nouveau texte de l’Annexe 1 des BPF, dédiée à la production de médicaments stériles, est soumis à commentaires depuis le 20 décembre 2017. La période de consultation durera trois mois et se déroulera du 20 décembre 2017 au 20 mars 2018. Le draft compte aujourd’hui 50 pages tandis que la précédente version n’en comptait que 16.
Parmi les changements notoires, un nouveau chapitre voit le jour dédié aux utilités comme l’eau ou les gaz, et une section est consacrée à la gestion des risques (QRM – Quality risk management). Plusieurs parties traitent des Form-Fill-Seal (FFS), Blow-Fill-Seal (BFS) et Single Use Systems (SUS).
Notons également le maintien de la classification des particules supérieures ou égales à 5 µm.
Le projet est téléchargeable sur le site du PIC/S.
Sommaire du draft
1. Scope
Additional areas (other than sterile medicinal products) where the general principles of the annex can be applied.
2. Principle
General principles as applied to the manufacture of medicinal products.
3. Pharmaceutical Quality System (PQS)
Highlights the specific requirements of the PQS when applied to sterile medicinal products.
4. Personnel
Guidance on the requirements for specific training, knowledge and skills. Also gives guidance to the qualification of personnel.
5. Premises
General guidance regarding the specific needs for premises design and also guidance on the qualification of premises including the use of barrier technology.
6. Equipment
General guidance on the design and operation of equipment.
7. Utilities
Guidance with regards to the special requirements of utilities such as water, air and vacuum.
8. Production and specific technologies
Discusses the approaches to be taken with regards to aseptic and terminal sterilisation processes. Also discusses different technologies such as lyophilization and Blow Fill Seal (BFS) where specific requirements may be required. Discusses approaches to sterilization of products, equipment and packaging components.
9. Viable and non-viable environmental and process monitoring
This section differs from guidance given in section 5 in that the guidance here applies to ongoing routinemonitoring with regards to the setting of alert limits and reviewing trend data.
The section also gives guidance on the requirements of Aseptic Process Simulation.
10. Quality control (QC)
Gives guidance on some of the specific Quality Control requirements relating to sterile medicinal products.
11. Glossary
Explanation of specific terminology.
Source : www.processpropre.com
