EU GMP Guidelines Chapter 4

The chap­ter 4 re­la­tes to the do­cu­men­ta­ti­on. A good do­cu­men­ta­ti­on is an es­sen­ti­al part of the qua­li­ty ma­nage­ment. Mo­reo­ver, it con­sti­tu­tes a key func­tion for the pro­duc­tion in com­pli­an­ce with the GMP re­gu­la­ti­ons. The tar­get of the do­cu­men­ta­ti­on is to con­trol, mo­ni­tor and re­cord all ac­ti­vi­ties di­rect­ly or in­di­rect­ly af­fec­ting the qua­li­ty of phar­maceu­ti­cal and me­di­ci­nal products.
As an in­tro­duc­tion, chap­ter 4 lists the do­cu­ments re­qui­red ac­cord­ing to GMP which must be in­clu­ded in the do­cu­men­ta­ti­on. The do­cu­men­ta­ti­on con­sists of the site mas­ter file, any type of re­gu­la­ti­ons re­sul­ting from in­st­ruc­tions and re­qui­re­ments and pro­to­cols or re­ports of any ac­tions ac­cord­ing to the re­gu­la­ti­ons. The in­di­vi­du­al do­cu­ment ty­pes and the me­dia used have to be spe­ci­fied in the vendor’s qua­li­ty ma­nage­ment sys­tem. Re­spec­ti­ve checks should be in­tro­du­ced to en­su­re the ac­cu­ra­cy, cor­rect­ness, avai­la­bi­li­ty and le­gi­bi­li­ty of the do­cu­ments. The do­cu­ments must be avail­ab­le du­ring the en­t­i­re re­ten­ti­on pe­ri­od. The­se aspects ap­p­ly for pa­per-ba­sed and elec­tro­nic do­cu­men­ta­ti­on sys­tems but also for mi­xed forms, so cal­led hy­brid sys­tems. Howe­ver, it is usual­ly im­pos­si­ble to re­gard pa­per prin­touts as com­ple­te. Com­ple­te me­ans in this case that the prin­tout is equip­ped with all re­le­vant data such as raw and me­ta­da­ta. As a re­sult, elec­tro­nic data is ad­di­tio­nal­ly used for re­se­arch pur­po­ses and to check the re­pro­du­ci­bi­li­ty of the re­sults. Thus, the pa­per prin­touts must con­tain uni­que re­fe­ren­ces poin­ting to the elec­tro­nic data.

In case of the batch do­cu­men­ta­ti­on and the batch re­lease, chap­ter 4 re­qui­res a man­da­to­ry elec­tro­nic batch re­lease, if the data pre­do­mi­nant­ly exists in di­gi­tal form. The chap­ter 4 of the EU GMP gui­de­li­ne also re­qui­res to va­li­da­te com­plex sys­tems in­clu­ding soft­ware and to check them re­gu­lar­ly. In this con­text, every chan­ge or ent­ry in a do­cu­ment must be si­gned and da­ted. De­s­pi­te the re­spec­ti­ve chan­ge, the data must be stored in a way that the ori­gi­nal in­for­ma­ti­on can also be re­trie­ved. The re­a­son for the chan­ge must be recorded.

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