Table of Contents
1.0 OBJECTIVE
To lay down the procedure for periodic evaluation of qualified / validated systems.
2.0 SCOPE
This procedure is applicable to all qualified equipment’s / systems for periodic evaluation.
3.0 RESPONSIBILITY
• Officer or above of QA
• Executive or above of QA
4.0 ACCOUNTABILITY
• Head Quality / QA
5.0 PROCEDURE
5.1 Periodic evalu. of qualified equipment’s / validated systems shall be carried out at a pre-determined frequency.
5.2 Periodic evalu. for qualified major equipment’s shall be carried out as per respective protocol.
5.3 Periodic evalu. of validated systems like HVAC, compressed air system etc. shall be performed as per their respective protocol.
5.4 For periodic evaluation of qualified instruments following points shall be considered but not limited to:
5.4.1 Any change control taken for the equipment, which initiates any major modification activity, relocation or maintenance of the equipment from the last periodic evaluation or qualification.
5.4.2 Any deviation taken for the equipment, which initiates any major maintenance activity, relocation or modification of the equipment from the last periodic evaluation or qualification.
5.4.3 Any major breakdown in the equipment from the last periodic evaluation or qualification.
5.4.4 Any product failure, which can be associated with the equipment from the last periodic evaluation or qualification.
5.4.5 Review of preventive maintenance activity performed.
5.4 All the data shall be compiled in the checklist provided.
5.5 Process Validation:
5.5.1 For review of process validation one batch of the product shall be subjected to validation as per pre-approved protocol.
5.5.2 Extensive testing of the batch and close monitoring of critical process parameters shall be performed.
5.5.3 Results shall be compiled in form of process validation report.
5.5.4 If any anomaly found same shall be reported to Head QA to decide further course of action.
5.5.5 Frequency:
• Qualified equipment: Every three years
• Validated system: As per respective protocols
• Process validation: Every four years