Het ontwerp van herziening van de Bijlage 1 is sinds 20 december 2017 in openbare raadpleging.
De nieuwe tekst, in herziening, van de Bijlage 1 van de BPF, gewijd aan de productie van steriele geneesmiddelen, is ter bespreking voorgelegd sinds 20 december 2017. De raadplegingsperiode duurt drie maanden en loopt van 20 december 2017 tot 20 maart 2018. Het ontwerp telt vandaag 50 bladzijden terwijl de vorige versie er maar 16 telde.
Bij de belangrijke wijzigingen, heeft een nieuw hoofdstuk gewijd aan de nutsvoorzieningen zoals water of gas het daglicht gezien en is een onderdeel gewijd aan het risicobeheer (QRM – Quality risk management). Meerdere delen gaan over de Form-Fill-Seal (FFS), Blow-Fill-Seal (BFS) en Single Use Systems (SUS).
Merk ook het behoud van de indeling van de partikels groter dan of gelijk aan 5 µm.
Het project kan op de website van PIC/S gedownload worden.
Inhoudsopgave van het ontwerp
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 routine monitoring 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
