Validation

Definition of Validation according to (FDA Guidelines 1987):

"Establishing the documented evidence which provides a high degree of assurance that a specific process will consistently produce a product of predetermined specifications and quality attributes.”

Definition of Validation according to according to (FDA Guidelines, 2011):

“Process validation is defined as the collection & evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that process is capable of consistently delivering quality product.”

Definition of Validation according to according to (EU GMP 1997):

“Action of proving, in accordance with the principles of Good Manufacturing Practice (GMP), that any procedure, process, equipment, material, activity or system actually leads to expected results.”

Benefits of Validation:

Validation can reduce costs by reducing,

1. Rejects
2. Reworks
3. Reliance on In-process controls
4. Down time

Types of Validation:

1. Prospective Validation

2. Concurrent Validation

3. Retrospective Validation

4. Re-Validation

Prospective Validation: Carried out during development stages by means of RISK ANALYSIS  of the production process.

• critical situation identify
• risk is evaluated
• potential cause investigation
• priority set
• overall assessment is made

 Concurrent Validation: Carried out during normal production ( commercial batches ) first 3 commercial scale batches must be monitored.

• trend analysis
• stability should carried out to an appropriate extent throughout the life of the product.   

 Retrospective Validation: useful in establishing the priority for the validation programmed. 

• past 20 production scale up batches. 

Re-validation: repeating the original validation. 

cause:

transfer of product one plant to another plant.

any kind of changes such as cleaning procedure, equipment etc.

increase or decrease the batch size.

meet the product specification.