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”
  • Nor­men (EN, ISO, DIN)

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IQ (Installation Qualification)

De­fi­ni­ti­on of the term („What is an In­stal­la­ti­on Qua­li­fi­ca­ti­on?“) The in­stal­la­ti­on qua­li­fi­ca­ti­on (IQ) do­cu­ments the im­ple­men­ta­ti­on of the re­qui­re­ments pre­vious­ly spe­ci­fied (e.g. in the de­sign qua­li­fi­ca­ti­on) as

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ISO 9001:2015 de­fi­nes ge­ne­ral princi­ples and terms re­la­ting to qua­li­ty ma­nage­ment. It also de­fi­nes the mi­ni­mum qua­li­ty ma­nage­ment re­qui­re­ments that an or­ga­ni­sa­ti­on must meet in