Qualification and validation
Our services:
- The creation of DQ/IQ/OQ/PQ (see below on page 4) phase qualification documents in accordance with GMP guidelines on documentation and in accordance with the EU GMP Guide, Annex 15 (http://www.gmp-compliance.org/eca_news_641.html)
- The creation of technical documents (user requirement specifications, product requirements documents [PRDs], functional specifications documents [FSDs], risk analyses, traceability matrices, qualification plans, test plans and reports).
RA: Risk assessment involves the creation of risk analyses, for example in accordance with ICH Q9 Quality Risk Management. These analyses serve in the identification and evaluation of the system’s critical parameters and ambient conditions.
DQ: “The compliance of the design with the GMP requirements should be demonstrated and documented” (Design Qualification) below.
IQ: “IQ is a documented verification that devices, systems and equipment have been installed or modified in compliance with the approved design and the recommendations of the manufacturer” (Installation Qualification) below.
OQ: “OQ is a functional inspection of the system on the basis of parameters to be established and within the defined restrictions and based on the knowledge of the process, system or equipment” (Operational Qualification) below.
PQ: “A performance qualification is a documented verification that devices, systems and equipment work effectively in the state that they are interconnected and on the basis of the approved process methods and product specifications and in a manner enabling them to be reproduced”.