EU Annex 1 is designed to outline the requirements for the manufacture of sterile medicinal products. Since its introduction in 1972, Annex 1 has undergone several changes and revisions. The most recent changes to the annex were made to reflect current best practices and technological advancements in the field of sterile product manufacturing.
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In short, a Contamination Control Strategy (CCS) is needed to achieve Annex 1. A Contamination Control Strategy (CCS) should be implemented across the facility in order to define all critical control points and assess the effectiveness of all the controls (design, procedural, technical and organizational) and monitoring measures employed to manage risks to medicinal product quality and safety.
It should establish robust assurance of contamination control which includes the prevention of contaminants such as endotoxins, microorganisms, and particulate control. Once established, CCS should be reviewed (with periodic management review) and updated where appropriate.
It should be noted that Where existing control systems are in place and are appropriately managed, these may not require replacement but should be referenced in the CCS and the associated interactions between systems should be understood.
Annex 1 Part 7 outlines Guidance on Cleanroom Garment, Protective Clothing & Donning Procedures. Read on to see what’s new and noteworthy:
According to the European Commission, the following outlines the reason for changes:
The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommend that the current version of annex 1, on the manufacture of sterile medicinal products, is revised to reflect changes in regulatory and manufacturing environments. The new guideline should clarify how manufacturers can take advantage of new possibilities deriving from the application of an enhanced process understanding by using innovative tools as described in the ICH Q9 and Q10 guidelines. The revision of Annex 1 should also take into account related changes in other GMP chapters and annexes as well as in other regulatory documents. The revised guideline will seek to remove ambiguity and inconsistencies and will take account of advances in technologies.
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