GMP Annex 1 – Final Revision
𝐓𝐡𝐞 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐔𝐧𝐢𝐨𝐧 𝐫𝐞𝐜𝐞𝐧𝐭𝐥𝐲 𝐢𝐬𝐬𝐮𝐞𝐝 𝐭𝐡𝐞 𝐟𝐢𝐧𝐚𝐥 𝐫𝐞𝐯𝐢𝐬𝐢𝐨𝐧 𝐨𝐟 𝐆𝐌𝐏 𝐀𝐧𝐧𝐞𝐱 1: 𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐞 𝐨𝐟 𝐒𝐭𝐞𝐫𝐢𝐥𝐞 𝐌𝐞𝐝𝐢𝐜𝐢𝐧𝐚𝐥 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐬, 𝐕𝐨𝐥. 4 𝐟𝐨𝐫 2022.
Many of the changes are more stringent than in previous versions. For example:
• Separate change rooms are required for entering and leaving production areas if the Contamination Control Strategy (CCS) indicates the risk of contamination is high
• For cleanroom qualification and EM, all grades are required to measure the total particles equal to or greater 0.5 and 5 µm/m3, with instructions to consider 5µm particles measurements where limits are not specified
• 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.