Validation and Qualification...
Information | Understanding | Best Practice.There are a number of stages in performing a validation program which are widely accepted as conforming to best validation practice, namely the stages of design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
DQ – Design Qualification.The design qualification is focused on ensuring there is documented verification that the proposed design is suitable for the intended purpose. The first element of A validation effort should be the design qualification (DQ). Where applicable the compliance of the design with Good Manufacturing Practice should be demonstrated and documented.
IQ – Installation qualification.The installation qualification is focused on ensuring that there is documented verification that an item of equipment, as installed or modified, complies with the approved design and manufacturer’s recommendations. This qualification covers the installation of equipment, any related piping, services, instrumentation, which are checked to confirm adherence with current engineering drawings and specifications. This stage includes the confirmation of the availability of relevant supplier operating instructions and maintenance requirements, confirms adequacy of calibration requirements and verification of materials of construction.
OQ – Operational qualification.The operational qualification stage is focused on ensuring that there is documented verification that the process, (or equipment, or facility) as installed or modified, performs as intended. The OQ should follow IQ. This stage involves finalizing calibration SOPs, cleaning procedures, confirmation of training, preventative maintenance requirements. The OQ results in the release of the facilities, systems and equipment following validation report approval.
PQ – Performance qualification.The performance qualification stage is focused on ensuring that there is documented verification that the entire process, related equipment and supporting facilities as connected together can perform effectively as required by the predetermined acceptance criteria. The PQ should follow successful completion and sign-off of the IQ and OQ stages. The PQ stage consists of test runs using production materials or qualified substitutes.
Product and Process Validation.
- The Validation Master Plan. Performing a Gap Analysis. Validation in the Design Process. Etc..
- How to ensure Validation efforts are aligned with potential Risks.
- How to ensure that Validation activity is appropriately documented, reviewed and aligned with requirements.
- Information | Understanding | Best Practice >>>
FDA Process Validation. General Principles and Practices
EU GMP Guidelines for Medicinal Products