PQ (Performance Qualification)

Definition of the term („What is a Performance Qualification?“) 

The Per­for­mance Qua­li­fi­ca­ti­on (PQ) is an ele­ment of the qua­li­fi­ca­ti­on for ma­chi­nes and de­vices espe­ci­al­ly ap­pli­ed in GMP-com­pli­ant in­dus­tri­al ma­nu­fac­tu­ring or of­fi­ci­al­ly con­trol­led pro­ducts (such as me­di­cinal sub­s­tances) as part of the qua­li­ty assu­rance. Fur­ther­mo­re, it ser­ves to en­su­re sus­tained qua­li­ty with re­gard to the me­a­su­re­ment re­sults of e.g. ana­ly­ti­cal in­stru­ments. If ne­ces­sa­ry, it is ad­jus­ted to the stan­dard ope­ra­ting procedures.

With re­gard to the ana­ly­ti­cal de­vices in the phar­maceu­ti­cal qua­li­ty con­trol, the PQ is equi­va­lent to the OQ (Ope­ra­ti­on Qua­li­fi­ca­ti­on). Ty­pi­cal­ly, the aspects of the Ope­ra­ti­on Qua­li­fi­ca­ti­ons (OP) are cho­sen to be mil­der than tho­se of the In­stal­la­ti­on Qua­li­fi­ca­ti­on (IQ). This way, the con­ti­nuous ope­ra­ti­on of the de­vices with con­stant ad­jus­t­ment can be en­su­red. Mo­reo­ver, all de­vices which ope­ra­te pro­per­ly un­der nor­mal con­di­ti­ons are also considered.

The fol­lo­wing sets of ru­les act as cha­rac­te­ristics for the PQ:

  • EU-GMP gui­de­line, chap­ter 3 and An­nex 15 and OMWHV § 5
  • ISO 17025
  • For sys­tem-spe­ci­fic, de­tail­ed re­qui­re­ments: EDQM Qua­li­ty Ma­nage­ment Guidelines
  • Ge­ne­ral re­qui­re­ments for pharmacopoeias
  • USP Ge­ne­ral Chap­ter <1058> “Ana­ly­ti­cal In­stru­ment Qualification”
  • Norms (EN, ISO, DIN)

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Our di­gi­ta­liza­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. The ba­sis of the d.3 life sci­en­ces sys­tem is an in­te­gra­ted 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.

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PQ (Performance Qualification)

De­fi­ni­ti­on of the term („What is a Per­for­mance Qua­li­fi­ca­ti­on?“)  The Per­for­mance Qua­li­fi­ca­ti­on (PQ) is an ele­ment of the qua­li­fi­ca­ti­on for ma­chi­nes and de­vices espe­ci­al­ly applied

Complaint management

De­fi­ni­ti­on of the term („What is a com­plaint?“)  A com­plaint ma­nage­ment in­cludes all me­a­su­res ta­ken by a com­pa­ny to pro­cess cus­to­mer com­plaints about the company’s