Validation

Question 1

What is process validation?

Definition from EMA and US FDA

Answer 1

A documented evidence-based process that demonstrates a high degree of assurance that a specific process consistently produces a product meeting its pre-determined specifications and quality attributes.

Question 2

EMA definition of process validation

Answer 2

“the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.”

Question 3

US FDA definition of process validation

Answer 3

“the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”

Question 4

What is the difference in EMA and FDA process validation guidelines?

Answer 4

• EMA guidelines place more emphasis on the need for a risk-based approach to process validation,
• the FDA guidelines focus on the importance of a comprehensive validation plan that includes ongoing process monitoring and control.

Question 5

What are the stages of process validation?

Answer 5

1. Process Design
2. Process Qualification
3. Continued Process Verification

Question 6

How many batches to be considered for process validation?

Answer 6

Minimum of 3 batches

Question 7

What is validation protocol?

Answer 7

A document that outlines specific procedures and requirements for a validation study.

Question 8

What should be the content of master validation protocol contain

Answer 8

Typically includes information on the:
* validation approach
* acceptance criteria
* testing methods
* data analysis plan for all stages of the validation process.

Question 9

What are the critical process parameters?

Answer 9

The process parameters that have a significant impact on the quality of the product and need to be monitored and controlled to ensure consistent product quality.

Question 10

What is the difference between the operating range and the acceptable range in a process?

Answer 10

The operating range refers to the range of process parameters that can be used to produce a product that meets its pre-determined specifications and quality attributes.
The acceptable range refers to the range of process parameters that are acceptable for the product to meet its pre-determined specifications and quality attributes, but may not necessarily be optimal for product quality.

Question 11

What is the revalidation criteria for process validation?

Answer 11

Process revalidation may be required when there is a significant change to the product or process that may affect product quality or when there is a deviation from the validated process that may affect product quality.

Question 12

What are the benefits of process validation?

Answer 12

• Ensuring consistent product quality
• Reducing the risk of product recalls
• Reducing the risk of regulatory non-compliance
• Improving process efficiency and productivity

Question 13

What is the action plan if a test failure is observed during process validation?

Answer 13

1. Stop the validation process
2. Investigate the root cause
3. Develope a corrective action plan
4. Re-test the process
5. Document the incident

Question 14

What is method validation?

Answer 14

A process of estblishing the reliability, accuracy and suitability of an analytical method for its intended purpose.
It involves the demonstration of the method’s fitness for use, based on its performance characteristics, such as accuracy, precision, specificity, sensitivity, limit of detection, and limit of quantitation.

Question 15

Why is method validation necessary?

Answer 15

To ensure analytical methods used for product testing or release are reliable, accurate and suitable for their intended purpose

Question 16

What is the lifecycle of an analytical method validation?

Answer 16

1. Devlopment
2. Validation
3. Continued verification of performance during routine use

Question 17

In what type of lab is the analytical validation performed?

Answer 17

Various labs

Question 18

Who should perform the analytical validation?

Answer 18

Qualified analysts who have necessary training, experience and knowledge

Question 19

When shoud the analytical validation be performed?

Answer 19

Before the method is used for routine testing or release of products.
Also should be performed whenever there is a change in method, equipment or software that could effect performance

Question 20

What analytical procedures should be validated?

Answer 20

All analytical procedures used for product testing or release

Question 21

When is the analytical method validation required?

Answer 21

Whenever a new analytical method is developed

Question 22

What are the required validation documents?

Answer 22

• validation procol
• validation report
• analytical method SOPs

Question 23

What characteristics should be considered during the validaiton of analytical methods?

Answer 23

1. Accuracy
2. Precision
3. Specificity
4. Sensitivity
5. Limit of detection
6. Limit or quantitation
7. Linearity
8. Range
9. Robustness
10. Ruggedness

Question 24

How should analytical validation be performed?

Answer 24

Using a well-designed and documented validation protocol that specifies the validation parameters, acceptance criteria and testing procedures.

Question 25

How is the degree of validaion determined?

Answer 25

by comparing the analytical method’s performance characteristics against the acceptance criteria specified in the validation protocol. If the method meets or exceeds the acceptance criteria, it is considered to be validated.

Question 26

What are the other integral parts of analytical method validation?

Answer 26

establishing the method’s stability, determining the method’s uncertainty, performing system suitability testing, and verifying that the method can detect and quantitate impurities.

Question 27

When should verification or revalidation be done?

Answer 27

whenever there is a change in the analytical method, equipment, or software that could affect the method’s performance. It should also be done periodically, as part of the continued verification of performance during routine use.