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

Definition of the term (“What is the Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients?”)

The Or­di­nan­ce on the Pro­duc­tion of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­di­ents is an or­di­nan­ce on the ap­pli­ca­ti­on of good ma­nu­fac­tu­ring prac­ti­ce in the pro­duc­tion of me­di­cinal pro­ducts and ac­ti­ve in­gre­di­ents and on the ap­pli­ca­ti­on of pro­fes­sio­nal prac­ti­ce in the pro­duc­tion of pro­ducts of 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 Ger­man Fe­de­ral Council.

Why is Section 2, §10 of the Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients significant?

Sec­tion 2, §10 is a spe­ci­fic por­ti­on of the Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­di­ents deal­ing with qua­li­ty assu­rance of me­di­cinal pro­ducts. It spe­ci­fies that com­pa­nies and or­ga­niza­ti­ons must main­tain a do­cu­men­ta­ti­on sys­tem cor­re­spon­ding to the ac­ti­vi­ties per­for­med in each case. Do­cu­men­ta­ti­on shall be made clear, ac­cu­ra­te and up to date. If re­cords are kept with elec­tro­nic data pro­ces­sing sys­tems, the sys­tem shall be suf­fi­ci­ent­ly va­li­da­ted. En­su­ring that data is available du­ring the re­ten­ti­on pe­ri­od and can be made re­a­da­ble wi­thin a re­asonable dead­line is a ba­sic re­qui­re­ment. The data must be pro­tec­ted against loss or da­ma­ge du­ring the en­ti­re re­ten­ti­on pe­ri­od. The re­cords shall be or­ga­nis­ed in such a way that the im­me­dia­te re­call of a pro­duct can be fa­ci­li­ta­ted. In re­la­ti­on to the soft­ware, the sup­pli­er must the­r­e­fo­re en­su­re that it is available at all times and that the do­cu­men­ta­ti­on is al­ways accessible .

What are the requirements for quality assurance?

Un­der Sec­tion 2, §10 of the Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­di­ents, ma­nu­fac­tu­r­ers are re­qui­red to es­tab­lish a com­pre­hen­si­ve qua­li­ty ma­nage­ment sys­tem. This in­cludes the mo­ni­to­ring and con­trol of all ma­nu­fac­tu­ring pro­ces­ses as well as the do­cu­men­ta­ti­on of pro­ce­du­res and results.

Why are inspections and audits important?

An im­portant com­po­nent of §10 is the re­gu­lar in­spec­tions and au­dits pe­for­med by the com­pe­tent aut­ho­ri­ties. The­se are in­ten­ded to en­su­re that ma­nu­fac­tu­r­ers com­ply with the re­qui­re­ments of the re­gu­la­ti­on on an on­go­ing basis.

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The significance of compliance

Com­pli­ance with Sec­tion 2, §10 of the Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­di­ents is cru­cial for ma­nu­fac­tu­r­ers of me­di­cinal pro­ducts. Fail­ure to com­ply with the­se re­gu­la­ti­ons can have se­rious le­gal consequences.

  • Risks of non-com­pli­ance: If ma­nu­fac­tu­r­ers do not com­ply with the re­qui­re­ments of §10, their pro­ducts may be clas­si­fied as un­safe or in­ef­fec­ti­ve. This can lead to re­calls, lia­bi­li­ty claims and re­pu­ta­tio­nal damage. 
  • Com­pli­ance Be­ne­fits: Strict com­pli­ance with §10, to the con­tra­ry, can con­tri­bu­te to en­su­re the qua­li­ty as well as safe­ty of me­di­cinal pro­ducts. This in­crea­ses con­su­mer con­fi­dence and pro­mo­tes the suc­cess of manufacturers.

Challenges and developments in Section 2, §10 of the Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients

Sec­tion 2, §10 of the Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­di­ents is not set in stone and is sub­ject to ch­an­ge and up­date to meet chan­ging requirements.

  • Cur­rent de­ve­lo­p­ments: In re­cent ye­ars, the­re have been se­ve­ral im­portant de­ve­lo­p­ments with re­gard to §10, in­clu­ding the in­tro­duc­tion of new tech­no­lo­gies for qua­li­ty assu­rance and har­mo­niza­ti­on with in­ter­na­tio­nal standards. 
  • Fu­ture out­look: The fu­ture of Sec­tion 2, §10 will li­kely evol­ve to re­flect ad­van­ces in drug ma­nu­fac­tu­ring. This re­qui­res con­ti­nuous ad­apt­a­ti­on and trai­ning of manufacturers.

What does §20 of the Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients require?

Sec­tion 20 “Sto­rage of do­cu­men­ta­ti­on” re­qui­res that all do­cu­ments can only be stored in rooms sui­ta­ble and per­mit­ted by the Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­di­ents. The room ty­pi­cal­ly has to be lo­ca­ted on the company’s pre­mi­ses. The Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­di­ents re­fers to the EU GMP Gui­de­line for fur­ther de­tails of the re­qui­re­ments con­tai­ned therein.

Conclusion

The Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­di­ents, in par­ti­cu­lar Sec­tion 2, §10, plays a key role in the qua­li­ty assu­rance of me­di­cinal pro­ducts in Ger­ma­ny. Com­pli­ance with the­se re­gu­la­ti­ons is of pa­ra­mount si­gni­fi­can­ce in en­su­ring the safe­ty and ef­fec­ti­ve­ness of me­di­cinal products.

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Frequently Asked Questions (FAQs)

Which com­pa­nies must com­ply with Sec­tion 2, §10 of the Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­di­ents?
All com­pa­nies that ma­nu­fac­tu­re me­di­cinal pro­ducts or ac­ti­ve in­gre­di­ents must com­ply with the pro­vi­si­ons of Sec­tion 10 of the Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal Ingredients.

Are the­re sanc­tions for non-com­pli­ance with §10?
Yes, le­gal sanc­tions such as fi­nes and pro­duct re­calls can be im­po­sed for non-com­pli­ance with Sec­tion 10 of the Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal Ingredients.

How can ma­nu­fac­tu­r­ers en­su­re that they com­ply with §10 of the Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­di­ents?
Ma­nu­fac­tu­r­ers can en­su­re com­pli­ance with §10 by im­ple­men­ting a com­pre­hen­si­ve qua­li­ty ma­nage­ment sys­tem and con­duc­ting re­gu­lar in­spec­tions and audits.

What is the role of in­spec­tions and au­dits in re­la­ti­on to §10?
In­spec­tions and au­dits are cri­ti­cal to en­su­ring that ma­nu­fac­tu­r­ers com­ply with the re­qui­re­ments of §10 and main­tain the qua­li­ty of their products.

Whe­re can I find fur­ther in­for­ma­ti­on on §10 of the Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­di­ents?
For more in­for­ma­ti­on on Sec­tion 10 of the Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­di­ents and other re­le­vant re­gu­la­ti­ons, plea­se vi­sit the web­site of the com­pe­tent he­alth authority.

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