THE EU STANDARD FOR "THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS" HAS BEEN PUBLISHED
The intent of the EU GMP Annex 1 is to provide guidance for the manufacture of sterile products.
The European Commission published a new revision of the EU GMP Annex 1 in August of 2022. This revision, coming into force on 25th August 2023, replaces that one released in 2008 and comes two years after the release of the most recent draft version of the document.
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The new guideline should clarify how manufacturers can take advantage of new possibilities deriving from applying an enhanced process understanding by using innovative tools described in the ICH Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System) guidelines. The revised policy will seek to remove ambiguity and inconsistencies and consider technological advances. The revision of Annex 1 should also consider related changes in other GMP chapters and annexes, and other regulatory documents.
In this article we will share the new guidance for CCIT (Container Closure Integrity Testing), one of the most important scope for the Antares Vision Group Inspection Machines Offer.
Container closure integrity (CCI) plays an important role in guaranteeing the sterility and stability of sterile injectable products. All Antares Vision Group inspection machines are realized in compliance with these new regulations.
The AV Group multi-technology approach guarantees to always be able to offer the best solution for each specific product.
Here the main CCIT Regulatory Guidance updates:
- Final containers should be closed by appropriately validated methods [Section 8.21 of Annex 1].
- Where final containers are closed by fusion, e.g. Blow-Fill-Seal (BFS), Form-Fill-Seal (FFS), Small and Large Volume Parenteral (SVP & LVP) bags, glass or plastic ampoules, the critical parameters and variables that affect seal integrity should be evaluated, determined, effectively controlled and monitored during operations.
Glass ampoules, BFS units and small volume containers (≤100 ml) closed by fusion should be subject to 100% integrity testing using validated methods.
Containers (>100 ml) closed by fusion, reduced sampling may be acceptable where scientifically justified and based on data demonstrating the consistency of the existing process, and a high level of process control.
It should be noted that visual inspection is not considered as an acceptable integrity test method [Section 8.22 of Annex 1].
- Samples of products using systems other than fusion should be taken and checked for integrity using validated methods. The frequency of testing should be based on the knowledge and experience of the container and closure systems being used. A scientifically justified sampling plan should be used. The sample size should be based on information such as supplier management, packaging component specifications and process knowledge [Section 8.23 of Annex 1].
- Containers sealed under vacuum should be tested for maintenance of vacuum after an appropriate pre-determined period prior to certification/release and during shelf life [Section 8.24 of Annex 1].
The industry has one year to implement, with a deadline for coming into operation on the 25th of August 2023 for all but Section 8.123 (Lyophilizers and associated product transfer and loading/unloading areas, which has been given two years (25th August 2024).
Complete GMP Annex 1 guidelines can be found at this link.