Qualification of equipment, rooms & premises
Purpose
To provide documented evidence, that production equipment including buildings, rooms, premises and utilities (water systems, HVAC, steam generator, a.o.) are installed and functioning within anticipated operating ranges and perform as intended and prescribed within the User Requirement Specifications (URS). Qualification activities normally are subdivided into DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) activities.
Prerequisites
- Established Quality Management / Quality Unit System.
- Qualified and well trained personnel.
- Good Engineering Practice System in place (GEP).
- Basic engineering documentation (e.g. actual P&IDs)
Procedures
- Discuss with client about their requirements and collect the required information for quotation (Signing of Secrecy Agreement recommended).
- Prepare an offer (fixed rate difficult, depends on the size of the plant and the number of pieces of equipment).
- Sign the contract and project commence.
- Nominate a Validation Team
- Prepare a Validation Master Plan (VMP)
- Prepare basic SOPs for plant qualification if not yet available
- Perform an impact analysis (selection of relevant equipment)
- Prepare a Project Plan Qualification (PPQ)
- Perform individual equipment risk assessments
- Prepare DQ-, IQ-, OQ- and PQ-protocols and discuss within the Validation Team for final approval
- Execute the individual activities DQ, IQ, OQ, PQ (including calibration)
- Collect and evaluate all relevant data and records
- Discuss the results within the validation team including all observed deviations
- Prepare the final Qualification Reports including Deviation Reports
- Compile all relevant qualification documents within the final qualification documentation folders
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What is GMP
Qualification
