QUALIFICATION AND VALIDATION

Design & Engineering Solutions

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The development of qualification documentation is an essential part of any successful validation program or study. SPECTRUM shall ensure that adequate and accurate documentation exists to prove that the system works as intended, that it is reproducible, and that it meets the established specifications and cGMP quality attributes.

 

Following major deliverables are envisaged:

·Preparation of a Validation Master Plan for the Systems.
·Review of Qualification protocols (DQ, IQ & OQ) submitted by supplier for systems designed by SPECTRUM.
·Review of Qualification protocols (DQ, IQ & OQ) submitted by supplier for Process Equipment.
·Review of the Qualification executed documents for critical systems / facility

SPECTRUM PHARMATECH CONSULTANTS PVT. LTD.

SPECTRUM PHARMATECH CONSULTANTS PVT. LTD.
Manufacturer
India

Primary focus area

Project Management / Consultants

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