In pharmaceutical, Validation is a requirement of Food, Drug, and pharmaceutical-related agencies such as USFDA and their cGMP guidance.
Process validation is the current requirement of pharmaceutical cGMP for finished pharmaceutical as per the 21CFR Part211 and as per GMP regulation of medical devices 21CFR Part820.
Process validation activities are described in three different stages.
The types of process validation are:
1. Process Design,
2. Process Qualification and
3. Continued process verification.
In the pharmaceutical industry, validation is the first formal step. Validation is an integral part of the pharmaceutical industry.
Before starting commercial batch manufacturing there are multiple activities. All activities are captured in different types of validation steps.
Here we will learn the different types of validation.
What are the Types of Validations?
There are four types of Validation.
1. Prospective validation
2. Concurrent validation
3. Retrospective validation
4. Revalidation
Let's understand all types of sequentially.
1. Prospective validation:
This type of validation is performed before production, during the product development stage.
The steps should follow while drug development is:
1. Evaluation of individual risk for each
2. Investigate it and access it
3. What are the potential causes.
4. What is the probability of a situation arising
5. The evidence of their effect
6. Draw up to trial plans
7. Set the priorities of the validation
After ensuring these steps can proceed for trial batch manufacturing. Prospective is essential to study yo minimize the potential risk of quality or error during the actual production of batch manufacturing.
2. Concurrent validation:
Concurrent validation is performed during the production of the batches. Concurrent validation is a study to gather data from each production stage. This study impacts greatly on the retrospective validation.
3. Retrospective validation:
This type of validation is performed post-production of the batch and helps to evaluate the control tests. Retrospective process validation is a validation of a process for a product already in distribution based upon accumulated production, testing, and control data.
4. Revalidation:
This type of validation is performed to check the system is still working and operating as originally validated.
Revalidation is assure that the validation completed is functioning properly.
Also read :
Aim of Validation: or
Why perform Validation?
The ultimate aim of validation is to confirm the quality is maintained and assure that system complies on each stage as per validation.
Validation is a process to established documentary evidence of process, procedure or activity carried out at the time of testing and production maintains a compliance level at all stages.
Additional information on Validation:
The multiple varieties of procedures, processes are involved invalidation needs to validate each process. The validation is not only limited to Prospective, concurrent, Retrospective, and Revalidation but also includes
>Equipment validation,
>Cleaning validation,
>Facility Validation,
>HVAC System Validation,
>Process Validation,
>Analytical Method Validation
>Computer System Validation.
>Equipment validation,
>Cleaning validation,
>Facility Validation,
>HVAC System Validation,
>Process Validation,
>Analytical Method Validation
>Computer System Validation.
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