Types of Process Validation

Types of Process Validation in Pharmaceuticals, along with purpose, scope, and examples:

Prospective Validation
- Conducted before commercial distribution of a new product or process.
- Demonstrates that the process design consistently produces quality products.
- Example: Validating a new tablet compression process before launching a product.
Concurrent Validation
- Performed during actual production of commercial batches.
- Applied when there’s urgency to supply the market or when prospective validation isn’t feasible.
- Example: Validating sterile injection filling while producing initial commercial lots.
Retrospective Validation
- Based on historical data of previously manufactured batches.
- Used for well-established products and processes with documented compliance.
- Example: Using 20 batches’ past records of paracetamol tablets to confirm process reliability.
Revalidation
- Done to confirm ongoing control after changes or after a defined time period.
- Ensures the validated state is maintained.
- Example: Revalidating granulation after changing the granulator or modifying batch size.
Continued Process Verification (CPV) / Ongoing Validation
- Part of lifecycle approach (ICH Q8, Q9, Q10, FDA, EU GMP).
- Involves continuous monitoring of critical parameters and quality attributes.
- Example: Statistical process control (SPC) charts for moisture content in granules during routine production.

🔹 Purpose of Process Validation

To provide documented evidence that a process consistently produces a product meeting its pre-defined specifications and quality attributes.
To build patient confidence by ensuring product safety, efficacy, and quality.
To comply with regulatory requirements (FDA, EMA, WHO, EU GMP, ICH).
To reduce batch failures, deviations, and product recalls.

Applies to all stages of product lifecycle: from development to commercial supply.
Covers manufacturing processes (granulation, compression, filling, sterilization, packaging).
Includes critical equipment (RMG, FBD, tablet press, autoclaves, sterilizers).
Applicable to changes in formulation, equipment, scale-up, site transfer, or after deviations.
Required for new products, process changes, and periodic revalidation.

Prospective: Validating lyophilization cycle parameters before launching an injectable.
Concurrent: Performing process validation of oral rehydration solution (ORS) while supplying urgent market demand.
Retrospective: Using PQR production data of ibuprofen tablets to establish consistency.
Revalidation: Revalidating a coating process affter relocating the coating machine.
Continued Verification: Routine trending of sterility test results for injectable batches.