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JTR will help you translate the project key quality and process needs into the user requirement (URS) and functional specifications (FS), this is the catalyst and driver which will be a point of reference throughout the entire validation life cycle Effective DQ where compliance of the design requirements with GMP is demonstrated and documented, as mandated in the EU GMP Annex 15 Quality critical attributes are assessed and defined for facility and process equipment commissioning FAT/SAT to qualification IQ, OQ, PQ.
From BOD and process acquisition, the management of EPCM and OEM suppliers is present throughout the early CQV activities. Management of FAT, management of install, commissioning and SAT readiness and SAT execution is a technical progress where JTR excels and delivers right the first time.
From post SAT OQ Process verification to PPQ qualification -EMPQ I Cleanroom Qualification/ CSV / Cleaning Validation / Continuous verification are all examples of additional deeper services that JTR may provide
From basic design to handover. A full end to end turn-key solution can be provided to ensure the product is able to meet market requirements on time.
With our international perspective and localized execution, our goal is to deliver valuable services that contribute to the creation of a brighter future.
info@jtrconsultancyservices.com
JTR Consultancy Services BV