GAMP stands for Good Au­to­ma­ted Ma­nu­fac­tu­ring Prac­ti­ce. The num­ber five re­pres­ents ver­si­on 5 which is cur­r­ent­ly the most up-to-date im­ple­men­ta­ti­on. GAMP5 of­fers a prag­ma­tic and prac­ti­cal gui­de for the im­ple­men­ta­ti­on of a GxP-com­pli­ant con­pu­ter-ba­sed sys­tem. It in­clu­des va­rious and scala­b­le ca­li­da­ti­on ap­proa­ches and stra­te­gies. The­se are al­ways risk-ba­sed and sum­ma­ri­ze many other gui­de­li­nes and stan­dards in the phar­maceu­ti­cal in­dus­try. GAMP5 is na­med as an in­dus­try stan­dard as it is also re­fer­red to in of­fi­cial do­cu­ments. Thus it has evol­ved as the stan­dard set of ru­les for the va­li­da­ti­on of com­pu­ter-ba­sed sys­tems in the phar­maceu­ti­cal in­dus­try. Howe­ver, the GAMP5 is not a stan­dard and the­re­fo­re has no bin­ding character.
The va­li­da­ti­on ef­forts ac­cord­ing to GAMP in prac­ti­se de­pend on the pa­ra­me­ters for data se­cu­ri­ty, the com­ple­xi­ty and no­vel­ty of the IT sys­tem used. The­se af­fect the per­spec­ti­ves and pro­ce­du­res and de­li­be­ra­te de­cisi­ons must be made. In­iti­al­ly, a ba­sic risk eva­lua­ti­on is con­duc­ted and then the ef­fects of the sys­tem are ana­ly­zed. Af­ter­wards, the func­tions are de­ter­mi­ned which may af­fect the data se­cu­ri­ty, the pro­duct qua­li­ty and the data in­te­gri­ty. Ba­sed on the­se func­tions, the func­tio­n­al risk as­sess­ment be­gins and the scope and num­ber of checks for the com­pu­ter-ba­sed sys­tem are spe­ci­fied. The­se must then be im­ple­men­ted and ve­ri­fied ac­cord­in­gly. The re­sul­ting mo­ni­to­ring of the en­t­i­re lifecy­cle al­lows the op­ti­miz­a­ti­on of pro­ce­du­res and pro­ces­ses, such as the avo­id­ance of du­pli­ca­te ac­ti­vi­ties through the in­te­gra­ti­on of com­pu­ter sys­tem activities.

If an or­ga­niz­a­ti­on in the re­gu­la­ted con­text wants to em­power its­elf with works of an IT sup­plier, then the ap­proach of in­iti­al ve­ri­fi­ca­ti­on of ade­qua­teness and re­lia­bi­li­ty of the sup­plier also ap­p­lies here. The IT com­pa­ny its­elf has to con­sist­ent­ly im­ple­ment the agreed qua­li­ty as­suran­ce mea­su­res and thus mo­ves into the fo­cus of the re­gu­la­to­ry aut­ho­ri­ties. This fact re­sults in some re­qui­re­ments for the sup­plier. In this con­text, GAMP5 re­gards a qua­li­ty-as­su­red sof­wa­re de­ve­lo­p­ment as ade­qua­te that fol­lows a lifecy­cle mo­del (V mo­del), i.e. a qua­li­ty-as­su­red and do­cu­men­ted ad­jus­t­ment and im­ple­men­ta­ti­on of the soft­ware with the re­spec­ti­ve qua­li­ty-as­su­red main­ten­an­ce and sup­port. The aspects have to be il­lus­tra­ted ba­sed on a qua­li­ty ma­nage­ment sys­tem.

Your path to digitization — Discover our software

Our di­gi­ta­liz­a­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. The ba­sis of the d.3 life sci­en­ces sys­tem is a ho­listic ECM/DMS sys­tem. The ECM/DMS sys­tem can be lin­ked to your exis­ting ERP sys­tem (e.g. SAP), thus en­ab­ling you to im­ple­ment al­most all do­cu­ment-ba­sed pro­ces­ses in your company. 
Live insight into the GxP-compliant document management system of d.velop Life Sciences

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EU GMP Guidelines Chapter 7

Chap­ter 7 “Out­sour­ced Ac­ti­vi­ties” of the EU GMP Gui­de­li­nes deals with the re­spon­si­bi­li­ties of the con­trac­tor and con­trac­ting en­ti­ty in the case of out­sour­ced activities.

Process audit

De­fi­ni­ti­on of the term (“What is a pro­cess au­dit?”)  The term pro­cess au­dit de­scri­bes the eva­lua­ti­on of the qua­li­ty ca­pa­bi­li­ty for pro­ducts, pro­duct groups and