FDA adopts ICH guid­ance on con­tin­u­ous man­u­fac­tur­ing

Af­ter com­plet­ing all four steps of the ICH’s guide­line process, the FDA joined with its Eu­ro­pean reg­u­la­to­ry col­leagues in adopt­ing this lat­est qual­i­ty-re­lat­ed guide­line on con­tin­u­ous man­u­fac­tur­ing, known as Q13.

The 42-page guid­ance, which has been in the works since 2018, clar­i­fies con­tin­u­ous man­u­fac­tur­ing con­cepts, de­scribes the var­i­ous sci­en­tif­ic ap­proach­es that can be used, and presents reg­u­la­to­ry con­sid­er­a­tions spe­cif­ic to this type of man­u­fac­tur­ing for both drug sub­stances and fin­ished prod­ucts.

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