GMP stands for “Good Ma­nu­fac­tu­ring Prac­ti­ce” or Ger­man “Gute Her­stell­pra­xis”. Thus, GMP con­tains po­li­ci­es and re­gu­la­ti­ons that al­ways have to be ob­ser­ved, if or­ga­niz­a­ti­ons deal with the pro­duc­tion and hand­ling of pro­ducts which may af­fect hu­mans’ qua­li­ty of life. Among them are me­di­ci­nal pro­ducts and food but also cos­me­tics. Sin­ce qua­li­ty de­via­ti­ons can have immedia­te ef­fects on the hu­man he­alth, qua­li­ty as­suran­ce plays a cen­tral role espe­cial­ly in phar­maceu­ti­cal pro­duc­tion. Thus, or­ga­niz­a­ti­ons in this sec­tor are ob­li­ged to in­tro­du­ce a GMP-com­pli­ant qua­li­ty ma­nage­ment sys­tem to gua­ran­tee the re­qui­red pro­duct qua­li­ty and to com­ply with le­gal re­qui­re­ments for the mar­ke­ting of their system.

A GMP-com­pli­ant qua­li­ty ma­nage­ment con­sist of several ele­ments such as the do­cu­ment ma­nage­ment for spe­ci­fi­ca­ti­on do­cu­ments to name but one. Re­qui­re­ments in­clu­de that the spe­ci­fi­ca­ti­on do­cu­ments such as work in­st­ruc­tions, pro­cess in­st­ruc­tions, form she­ets etc. must be ver­si­on-con­trol­led and sub­ject to a de­fi­ned lifecy­cle. Mo­reo­ver, the­se do­cu­ments must have an au­dit trail in which all ac­tions, espe­cial­ly chan­ges, are to be log­ged. Wi­thout com­pli­an­ce to the GMP re­gu­la­ti­ons, no or­ga­niz­a­ti­on gets the ap­pro­val to pro­du­ce phar­maceu­ti­cal products.

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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Medical Device Regulation (MDR)

Me­di­cal De­vice Re­gu­la­ti­on (MDR) – Re­gu­la­ti­on 2017/745 (EU) on Me­di­cal De­vices The Ger­man coun­ter­part to the term “Me­di­cal De­vice Re­gu­la­ti­on” is “Me­di­zin­pro­duk­te­ver­ord­nung”. The Eu­ro­pean Union


De­fi­ni­ti­on of the term (“What is an au­dit?”) An au­dit checks, if the re­qui­re­ments, pro­ces­ses, and gui­de­li­nes meet pre­scri­bed stan­dards or norms. Due to the high