Concept of Revalidation in Pharmaceuticals

1. Definition

Revalidation is the process of repeating validation (process, equipment, cleaning, or analytical method) to ensure that the system or process remains in a state of control throughout its lifecycle.
It confirms that the product continues to meet predetermined quality specifications even after changes or over time.

2. Purpose

• To maintain GMP compliance.

• To ensure product quality and patient safety.

• To comply with regulatory expectations (US FDA, EMA, WHO, MHRA).

• To detect and correct process drifts or equipment performance degradation.

3. Types of Revalidation

a. Periodic Revalidation

• Performed at predefined intervals (e.g., every 2–3 years).

• Ensures continued compliance even without major changes.

• Based on risk assessment and product/process criticality.

b. Revalidation After Change (Requalification)

Triggered by changes that may impact product quality, such as:

• Process changes (e.g., mixing time, drying temperature).

• Equipment modifications or relocation.

• Change in raw material supplier or grade.

• Facility layout or environmental control changes.

• Major deviations or repeated CAPA.

4. Scope of Revalidation

• Process Validation – manufacturing consistency.

• Cleaning Validation – cleaning effectiveness after changes in equipment or products.

• Analytical Method Validation – accuracy, precision, and reliability after method or instrument changes.

• Computer System Validation – after software upgrades or configuration changes.

5. Steps in Revalidation

1. Trigger Identification – planned change, deviation, or periodic requirement.

2. Protocol Preparation – defining scope, acceptance criteria, sampling plan, and tests.

3. Execution – performing validation activities per protocol.

4. Data Review – assessing results against acceptance criteria.

5. Report & Approval – documenting conclusions and obtaining QA approval.

6. Regulatory References

• EU GMP Annex 15 – Qualification and Validation.

• US FDA Process Validation Guidance (2011) – Lifecycle approach.

• WHO TRS 937 – Validation principles.

7. Key GMP Points

• Revalidation must be pre-approved by QA via protocol.

• Results must be documented and reviewed before batch release.

• Linked to change control and CAPA systems.

• Follow ALCOA+ data integrity principles.

✅ Summary:
Revalidation = “Validation Again” to ensure processes, systems, and equipment remain effective, controlled, and compliant throughout their operational life.

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