In GMP, qualification and validation is just as important for a cleanroom as it is for the manufacturing process that take place in there. The Qualification and Validation cycle starts at the beginning of a new cleanroom design and install programme and follows the cleanroom throughout its lifetime.
Key Points
All qualification and validation activities should be planned.
Qualification and validation activities should only be performed by suitably trained personnel, following approved procedures.
Qualification and validation protocols should be prepared which define the testing to be performed and the associated acceptance criteria.
Appropriate checks should be incorporated into qualification and validation to ensure the integrity of all data obtained.
Timelines
For a new cleanroom, the qualification and validation should be fully completed before the cleanroom is handed over to a customer.
Existing cleanrooms should be requalified on a regular basis. Where there is a regulatory requirement for requalification, the maximum time interval must be adhered to.
When remedial work is performed on an existing cleanroom, which impacts the operation of the cleanroom, e.g. interruption of air movement, requalification should be reconsidered.
Examples of GMP Qualification and Validation Abbreviations
DQ Design Qualification
IQ Installation Qualification
OQ Operational Qualification
PQ Performance Qualification
URS User Requirement Specification
VMP Validation Master Plan
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