This description has agone been espoused in guidance documents worldwide, including the current good manufacturing practices( cGMP) regulations blazoned by European nonsupervisory agencies and the International Conference on Harmonization( ICH). When the 1987 FDA guidance was published, evidence during early stages of product development( before Phase 1 clinical trials) was minimal Producing a series( three to five) of consecutive full- scale conformance lots in good outfit under cGMP conditions Outfit qualification involved attesting and establishing that the design, installation qualification( Command), operation qualification( OQ), and performance qualification( PQ) of the manufacturing outfit were suitable of satisfying the process conditions. Analytical styles used for in- process testing and final product release were validated former to induction of full- scale conformance lots. After conformance lot blessing, the validated process could not be materially modified without revalidation to confirm that the process was still under control and still reacted in a product of respectable( analogous) quality.