Eu­ro­pean Com­mis­sion un­veils long-await­ed re­vi­sion to guide­line on ster­ile drug man­u­fac­tur­ing

Build­ing off a pre­vi­ous re­vi­sion in 2007, the Eu­ro­pean Com­mis­sion on Thurs­day re­leased its lat­est up­date to its guide­line on man­u­fac­tur­ing ster­ile drugs.

The Com­mis­sion said its up­dat­ed 58-page An­nex 1, which pro­vides tech­ni­cal guid­ance on the prin­ci­ples and guide­lines around ster­ile drug GMPs, fol­lows the rec­om­men­da­tion of the GMP/GDP In­spec­tors Work­ing Group and the PIC/S com­mit­tee to re­flect changes in both reg­u­la­to­ry and man­u­fac­tur­ing.

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