Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (“Arzneimittel- und Wirkstoffherstellungsverordnung — AMWHV”, section 2, §10, §20)

The Ger­man Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­ci­nal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­dients is an or­di­nan­ce for the im­ple­men­ta­ti­on of the prac­ti­ce for pro­duct with hu­man ori­gin. It was is­sued by the Fe­deral Mi­nis­tries of He­alth and Food, Agri­cul­tu­re and Con­su­mer Pro­tec­tion in agree­ment with the Fe­deral Mi­nis­ters of Eco­no­mics, Tech­no­lo­gy and the En­vi­ron­ment and with the con­sent of the Bundesrat

Com­pu­ter-ba­sed sys­tem are dealt with in sec­tion 2, §10 of the Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­ci­nal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­dients. It spe­ci­fies that com­pa­nies and or­ga­niz­a­ti­ons have to main­tain a do­cu­men­ta­ti­on sys­tem in ac­cordance with the re­spec­ti­ve ac­ti­vi­ties per­for­med. The do­cu­men­ta­ti­on must be main­tai­ned clear­ly and wi­thout er­rors and must be up-to-date. If re­cords are kept with elec­tro­nic data pro­ces­sing sys­tems, the sys­tem must be suf­fi­ci­ent­ly va­li­da­ted. It is an un­der­ly­ing re­qui­re­ment to en­su­re that the in­for­ma­ti­on is avail­ab­le du­ring the en­t­i­re le­gal re­ten­ti­on pe­ri­od and can be pro­vi­ded in le­gi­ble form in a re­a­son­ab­le amount of time. The data must be pro­tec­ted against loss or da­ma­ge du­ring the en­t­i­re re­ten­ti­on pe­ri­od. The re­cords must be or­ga­ni­zed in a way al­lowing for an immedia­te re­call of the pro­duct. With re­gard to soft­ware, the pro­vi­der must the­re­fo­re en­su­re that it is avail­ab­le at all times and that the do­cu­men­ta­ti­on is al­ways accessible.
Fi­nal­ly, §20 “Sto­rage of the do­cu­men­ta­ti­on” (“Auf­be­wah­rung der Do­ku­men­ta­ti­on”) re­qui­res that any do­cu­ments may only be stored in rooms which are re­gar­ded as ade­qua­te and ap­pro­ved in the Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­ci­nal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­dients. The room ty­pi­cal­ly has to be lo­ca­ted on the company’s pre­mi­ses. For fur­ther de­tails on the con­tai­ned re­qui­re­ments, the Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­ci­nal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­dients re­fers to the EU-GMP guideline.

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