Periodic Review and Requalification

1. Periodic Review

Definition:
A systematic review of facilities, utilities, equipment, and computerized systems at defined intervals to ensure they remain in a state of control and continue to comply with regulatory requirements.

Purpose:

• To verify that equipment and systems are operating as intended.

• To check for any deviations, changes, or trends that may impact product quality.

• To ensure compliance with cGMP, FDA, EMA, and other regulatory guidelines.

Examples:

• Reviewing preventive maintenance and calibration records.

• Checking equipment performance logs.

• Reviewing deviations, change controls, and CAPA trends.

• Assessing whether critical utilities (e.g., purified water, pure steam, HVAC) are meeting specifications.

2. Requalification

Definition:
The process of repeating qualification activities (IQ/OQ/PQ) partially or fully, after a defined time period or when major changes are made, to ensure continued suitability of equipment, systems, and utilities.

Purpose:

• To demonstrate that the equipment/system still performs as originally validated.

• To confirm no performance drift has occurred over time.

• To verify critical parameters remain within the acceptance limits.

When Required:

• After significant maintenance, modification, or relocation.

• After repeated deviations or failures linked to the system/equipment.

• On a scheduled basis (e.g., every 1–3 years, depending on risk assessment).

Regulatory Basis

• EU GMP Annex 15: Requires periodic review of facilities, utilities, and equipment.

• ICH Q9 (Quality Risk Management): Encourages risk-based approach to determine review/requalification frequency.

• FDA Guidance: Emphasizes maintaining the validated state throughout the lifecycle.

Key Difference

• Periodic Review = Check and document whether requalification is needed.

• Requalification = Actual execution of qualification tests to confirm validated state.

✅ In summary:
Periodic Review ensures ongoing compliance and control, while Requalification confirms performance through testing. Together, they maintain equipment and systems in a validated state throughout their lifecycle.