Validation Types

Which type of validation is conducted before the new product is released for distribution?

• Prospective Validation

• Retrospective Validation

• Concurrent Validation

• Revalidation

Which validation type uses historical data to validate established processes?

• Prospective Validation

• Retrospective Validation

• Concurrent Validation

• Revalidation

When validation is performed during actual production, it is referred to as

• Prospective Validation

• Retrospective Validation

• Concurrent Validation

• Revalidation

What type of validation is necessary when there are changes in the manufacturing process?

• Prospective Validation

• Retrospective Validation

• Concurrent Validation

• Revalidation

Which of the following requires documented evidence that the process consistently produces a quality product?

• Prospective Validation

• Retrospective Validation

• Concurrent Validation

• All of the above

Which type of validation is typically conducted as part of a routine quality assurance program?

• Prospective Validation

• Retrospective Validation

• Concurrent Validation

• Revalidation

Retrospective validation is not suitable for:

• New products

• Established products with historical data

• Processes with consistent quality history

• Processes without significant changes

Revalidation is mandatory when

• There are changes in the raw materials

• There are changes in equipment

• There are changes in the manufacturing process

• All of the above

Which type of validation is used to confirm that any changes to a process or equipment do not adversely affect the product's quality?

• Prospective Validation

• Retrospective Validation

• Concurrent Validation

• Revalidation

In retrospective validation, how many batches must be evaluated for historical data from past production batches?

• 3 batches

• 5 batches

• 10-30 batches

• more than 30 batches