Continued Process Verification in the Pharmaceutical Industry

Background and Challenges

The imple­men­ta­ti­on of CPV in the phar­maceu­ti­cal sec­tor has beco­me a neces­sa­ry requi­re­ment within pro­cess vali­da­ti­on by regu­la­to­ry aut­ho­ri­ties (FDA, EMA). Even though manu­fac­tu­r­ers of phar­maceu­ti­cal pro­ducts have always imple­men­ted rele­vant GxP in the inte­rest of pati­ent safe­ty, they are con­fron­ted with spe­cial frame­work, pro­cess and orga­niza­tio­nal con­di­ti­ons in this con­text:

  1. Com­ple­xi­ty: The manu­fac­tu­re of drugs and phar­maceu­ti­cal pro­ducts invol­ves a varie­ty of pro­ces­ses (inclu­ding manu­fac­tu­ring, pro­ces­sing, pack­a­ging, and sto­rage) that must be moni­to­red and veri­fied, and bet­ween which the­re are inter­ac­tions.

  2. Regu­la­to­ry requi­re­ments: The phar­maceu­ti­cal indus­try is sub­ject to strin­gent regu­la­to­ry requi­re­ments. CPV must be imple­men­ted in com­pli­ance with the­se requi­re­ments.

  3. Data inte­gri­ty and data manage­ment: phar­maceu­ti­cal com­pa­nies must ensu­re that all data is cap­tu­red, stored and trans­mit­ted cor­rect­ly, com­ple­te­ly, con­sis­t­ent­ly and unal­tera­b­ly. The CPV solu­ti­on must ensu­re appro­pria­te data manage­ment sys­tems and pro­ces­ses, as well as com­pli­ance with strict secu­ri­ty and data pro­tec­tion stan­dards.

  4. Vali­da­ti­on: The neces­sa­ry vali­da­ti­on of ana­ly­ti­cal methods can be time-con­sum­ing and resour­ce-inten­si­ve, as exten­si­ve test­ing and data com­pa­ri­son is requi­red to con­firm the relia­bi­li­ty of the methods.

  5. Chan­ge manage­ment: chan­ges to pro­ces­ses and manu­fac­tu­ring methods are com­mon, whe­ther due to opti­miza­ti­on, pro­duct impro­ve­ment, or regu­la­to­ry requi­re­ments. CPV must be able to effec­tively mana­ge such chan­ges and ensu­re that moni­to­red and veri­fied pro­cess per­for­mance con­ti­nues to meet requi­re­ments.

How StatSoft can help you

We gui­de our cus­to­mers through the com­ple­xi­ty of this task: Stat­Soft com­bi­nes many years of exper­ti­se with CPV in the phar­maceu­ti­cal sec­tor with in-depth know-how in imple­men­ting appro­pria­te solu­ti­ons with TIBCO Data Sci­ence / Sta­tis­ti­ca soft­ware. At the same time, we pro­vi­de sup­port in dis­co­ve­ring and harnes­sing the oppor­tu­ni­ties that ari­se in rene­wing pro­ces­ses: If pro­ces­ses are desi­gned fle­xi­bly, the ana­ly­ti­cal spec­trum can be signi­fi­cant­ly expan­ded in the future.

Tog­e­ther with you, we eva­lua­te which solu­ti­on is sui­ta­ble and how the archi­tec­tu­re should be desi­gned, based on the spe­ci­fic con­di­ti­ons of your com­pa­ny and the con­cre­te pro­cess requi­re­ments. In doing so, our focus is on an inte­gra­ti­ve view of the requi­re­ment, becau­se the embed­ding of CPV-com­pli­ant pro­ces­ses always moves in the con­text of exis­ting, diver­se data sources and sys­tems and pro­ces­ses.

The ana­ly­ti­cal soft­ware Sta­tis­ti­ca can estab­lish con­nec­tions to any data source and meets the strin­gent requi­re­ments of the phar­maceu­ti­cal indus­try, so that the solu­ti­ons pro­vi­ded can be vali­da­ted with litt­le effort.

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If you have any ques­ti­ons about our pro­ducts or need advice, plea­se do not hesi­ta­te to cont­act us direct­ly.

Tel.: +49 40 22 85 900-0

Sasha Shiran­gi (Head of Sales)