How do I qualify an existing equipment, it is not used for GxP purposes today but planning on doing it soon. The equipment undergoes a supplier’s maintenance that includes PM and OQ annually.
Do the GxP and Qualify the machine by IOPQ.
Every equipment should undergo “impact assessment” where 6 or 7 questions will be asked about the equipment to classify it. The result of the assessment will dictate the required qualifications (also in terms of CSV and data integrity).
Could you give example of typical questions to ask?
The equipment is already installed, is an IQ necessery then?
yes, need to verify. like URS, Change controls, Utilities, material of construction, Major components, safety, appearance, Documents, sop, Calibrations verification, Maintenance verification etc…
OQ: Alarams, I/Os, interlocks, securities, operations parameters, operational sequence, software verification, screen navigation, recipe verification.
PQ; process parameters.
Here are the questions:
- Does the system come into contact with the product?
- Does the system provide or produce an ingredient or solvent?
- Is the system used in cleaning/sterilizing (of product contact equipment)?
- Does the system preserve product status?
- Does the system produce data evaluated to accept or reject product?
- Does the system control the process in such a way as to affect product quality without independent verification of the control system performance?
Regards,
Arnan