GMP Annex 1 โ€“ Final Revision

๐“๐ก๐ž ๐„๐ฎ๐ซ๐จ๐ฉ๐ž๐š๐ง ๐”๐ง๐ข๐จ๐ง ๐ซ๐ž๐œ๐ž๐ง๐ญ๐ฅ๐ฒ ๐ข๐ฌ๐ฌ๐ฎ๐ž๐ ๐ญ๐ก๐ž ๐Ÿ๐ข๐ง๐š๐ฅ ๐ซ๐ž๐ฏ๐ข๐ฌ๐ข๐จ๐ง ๐จ๐Ÿ ๐†๐Œ๐ ๐€๐ง๐ง๐ž๐ฑ 1: ๐Œ๐š๐ง๐ฎ๐Ÿ๐š๐œ๐ญ๐ฎ๐ซ๐ž ๐จ๐Ÿ ๐’๐ญ๐ž๐ซ๐ข๐ฅ๐ž ๐Œ๐ž๐๐ข๐œ๐ข๐ง๐š๐ฅ ๐๐ซ๐จ๐๐ฎ๐œ๐ญ๐ฌ, ๐•๐จ๐ฅ. 4 ๐Ÿ๐จ๐ซ 2022.

Many of the changes are more stringent than in previous versions. For example:

โ€ข Separate change rooms are required for entering and leaving production areas if the Contamination Control Strategy (CCS) indicates the risk of contamination is high

โ€ข For cleanroom qualification and EM, all grades are required to measure the total particles equal to or greater 0.5 and 5 ยตm/m3, with instructions to consider 5ยตm particles measurements where limits are not specified

โ€ข For Interventions, all non-qualified interventions should be recorded in the batch record, authorized by the quality unit, and assessed.

We thought the most interesting change required the bioburden samples be taken prior to the first filter if a redundant filtration setup is used.

These are just a few of the changes to the annex. To learn how these and other updates could impact your operations, download our GMP Annex 1 guidelines and reach out.


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