PQ (Performance Qualification)

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

In the world of phar­maceu­ti­cal ma­nu­fac­tu­ring and qua­li­ty assu­rance, per­for­mance qua­li­fi­ca­ti­on (PQ) is a cri­ti­cal step in en­su­ring that equip­ment and sys­tems used as part of qua­li­ty assu­rance, par­ti­cu­lar­ly in the GMP-com­pli­ant in­dus­tri­al ma­nu­fac­tu­re of re­gu­la­to­ry con­trol­led pro­ducts (e.g., phar­maceu­ti­cals), func­tion pro­per­ly in the pro­duc­tion en­vi­ron­ment and meet spe­ci­fied re­qui­re­ments. The per­for­mance qua­li­fi­ca­ti­on (PQ) is a cri­ti­cal part of the va­li­da­ti­on pro­cess in the phar­maceu­ti­cal in­dus­try and is also the fi­nal pha­se of equip­ment qua­li­fi­ca­ti­on, fol­lo­wing the in­stal­la­ti­on qua­li­fi­ca­ti­on (IQ) and ope­ra­ti­on qua­li­fi­ca­ti­on (OQ).

The significance of PQ

The PQ has a cru­cial si­gni­fi­can­ce as it en­su­res that all phar­maceu­ti­cal pro­ces­ses are sta­ble and re­lia­ble. Any er­ror or fail­ure at this stage can have se­rious con­se­quen­ces for the pro­duct quality.

The phases of performance qualification

The PQ con­sists of se­ve­ral pha­ses that must be car­ri­ed out sys­te­ma­ti­cal­ly to en­su­re the pro­per func­tio­ning of equip­ment and systems.

  • Pre­pa­ra­ti­on: In this pha­se, all ne­ces­sa­ry do­cu­men­ta­ti­on is crea­ted, in­clu­ding test plans and pro­to­cols. It is im­portant to en­su­re that all re­qui­re­ments and spe­ci­fi­ca­ti­ons are cle­ar­ly defined. 
  • Exe­cu­ti­on of tests: The ac­tu­al tests are per­for­med ac­cor­ding to the pre­pared plans. Du­ring this pro­cess, all aspects of the de­vice func­tion are tes­ted to en­su­re that they meet the requirements. 
  • Do­cu­men­ta­ti­on of re­sults: All test re­sults are do­cu­men­ted in de­tail. This is cri­ti­cal for com­pli­ance and al­lows de­via­ti­ons or pro­blems to be iden­ti­fied and resolved. 
  • Ana­ly­sis and ap­pr­oval: The coll­ec­ted data and re­sults are ana­ly­zed and an ap­pr­oval or re­jec­tion of the equip­ment qua­li­fi­ca­ti­on is made.

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Best practices for a successful PQ

A suc­cessful PQ re­qui­res careful plan­ning and exe­cu­ti­on. Here are some best prac­ti­ces to keep in mind:

  • Clear do­cu­men­ta­ti­on: En­su­re that all do­cu­men­ta­ti­on, in­clu­ding test logs and re­ports, is ac­cu­ra­te and complete. 

  • Em­ployee Trai­ning: Em­ployees per­forming the tests should be well trai­ned to en­su­re ac­cu­ra­te and re­lia­ble results. 

  • Risk eva­lua­ti­on: Con­duct a tho­rough risk eva­lua­ti­on pri­or to the PQ to iden­ti­fy po­ten­ti­al is­sues in advance. 

  • Va­li­da­ted test me­thods: Use va­li­da­ted test me­thods that com­ply with cur­rent in­dus­try standards.

Conclusion

The per­for­mance qua­li­fi­ca­ti­on (PQ) is a cri­ti­cal step in the qua­li­fi­ca­ti­on of phar­maceu­ti­cal plants. It en­su­res that all equip­ment and sys­tems func­tion pro­per­ly and do not com­pro­mi­se pro­duct qua­li­ty. Careful plan­ning, exe­cu­ti­on and do­cu­men­ta­ti­on are es­sen­ti­al for the suc­cess of the PQ.

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Frequently Asked Questions (FAQs)

Why is the Per­for­mance Qua­li­fi­ca­ti­on (PQ) so im­portant in phar­maceu­ti­cal pro­duc­tion?
The PQ is im­portant be­cau­se it en­su­res that all equip­ment and sys­tems are func­tio­ning pro­per­ly, which en­su­res pro­duct qua­li­ty and pa­ti­ent safety.

What are the pha­ses of the PQ?
The PQ in­cludes the pha­ses of pre­pa­ra­ti­on, exe­cu­ti­on of tests, do­cu­men­ta­ti­on of re­sults, and ana­ly­sis as well as approval.

What hap­pens if the PQ fails?
If the PQ fails, the re­asons must be iden­ti­fied and cor­rec­ted be­fo­re the plants and sys­tems can be put into operation.

How of­ten must a PQ be per­for­med?
The PQ must be per­for­med each time new equip­ment is in­stal­led or si­gni­fi­cant ch­an­ges are made to exis­ting equipment.

What is the role of PQ in re­gu­la­to­ry com­pli­ance?
The PQ is cri­ti­cal for com­pli­ance with re­gu­la­ti­ons and stan­dards in the phar­maceu­ti­cal in­dus­try as it en­su­res that plants are func­tio­ning pro­per­ly. Re­gu­la­ti­ons in this re­gard are, for example: 

  • EC GMP Gui­de­line, Chap. 3 and An­nex 15 and AMWHV § 5
  • ISO 17025
  • For plant-spe­ci­fic, de­tail­ed re­qui­re­ments: EDQM Qua­li­ty Ma­nage­ment Guidelines
  • Ge­ne­ral re­qui­re­ments of pharmacopoeias
  • USP Ge­ne­ral Chap­ter <1058> “Ana­ly­ti­cal In­stru­ment Qualification”
  • Stan­dards (EN, ISO, DIN)

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