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Réglementation : BPF, Draft of Annex 1 has been published

The public consultation phase for the draft revision of Annex 1 started on 20 December 2017.

The revised version of the text for Annex 1 of the GMP, dedicated to the production of sterile drugs, has been subject to comments since 20 December 2017. The consultation period will last for three months, and will run from 20 December 2017 until 20 March 2018. The current draft has 50 pages, whereas the previous version only had 16.

The main changes include a new chapter dedicated to utilities such as water and gas, and a section on risk management (QRM – Quality risk management). There are several parts covering Form-Fill-Seals (FFS), Blow-Fill-Seals (BFS) and Single Use Systems (SUS).

It is also worth noting that the classification for particles more than or equal to 5µm has been kept.

The draft version can be downloaded from the PIC/S website.

Draft summary

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.

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