Saturday, June 4, 2022

Validation in Pharmaceutical Industry Types of Pharma Validation

Validation in Pharmaceutical Manufacturing Industry: 
Validation is an activity of gathering data of an adapted system, equipment, procedure, method or written instructions which are followed in manufacturing, testing and releasing of pharmaceutical product for human consumption by a pharmaceutical manufacturing company and analysis of the gathered data to identify if they are able to deliver consistent, error free, accurate results and predefined quality product consistently.

Here most important factor desired in the pharmaceutical manufacturing is accurate reliable and consistent process, procedure, method, trained personnel work. 

For example a system of Calculation of a data sheet or computer excel sheet, is used for testing and interpretation of results, such systems are required.
The person who is doing testing is able to do the required analysis error free is evaluated which is called analysts validation.

1. Manufacturing Process Validation
2. Equipment Validation.
3. Cleaning Validation
4. Analytical instruments Validation
5. Analytical Method Validation.
6. Validation of Microbiological tests.
7. Disinfectant Validation
8. Sterilisation Validation
9. Clean room Validation
10. Media fill validation.
11. Computer System validation.

US FDA have given special emphasis on validation and it is prim requirement of US FDA pre-qualification.

Why validation is important in pharmaceutical Industry ? 

Good manufacturing Practices Guidelines issued by WHO, USFDA, European Union, and CDISCO India. All guidelines mention that pharmaceutical manufacturing company must have a procedure to verify the each and every
Procedure method equipment and written instructions used during manufacturing testing and releasing of pharmaceutical product for human consumption in USA or else where, must be verified periodically for their accuracy effectiveness to deliver consistent accurate desired quality standard product and it's test results consistently.
Failing to do so the pharmaceuticals manufactured in the Pharma company are termed to be of substandard quality, and spurious.

Validation in pharmaceutical manufacturing company is mandatory requirement. 

1 comment:

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