Validation is a concept used in the Pharmaceutical manufacturing industry. US-FDA had been invented in the mid-seventies in pharma product analysis. This is documented proof of a process to be consistent over time. The Importance of Validation in Pharmaceutical companies is tremendous.
It is now part of GMP process to qualify for certificate of Good Manufacturing Practice in a manufacturing plant. On the occasion of every audit by drug department Master Validation Plan is required.
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Key Benefits of Validation
There are several benefits of Validation in the pharmaceutical industry some of them are illustrated below:
Validation of the process helps to find any big or small fault in the manufacturing process. That helps to be prepared to avoid such faults in the future.
It helps to find any error of deviation in the process or system over time.
Significant process parameters and controls can be determined during the validation of the process.
The system and equipment can study thoroughly by the validation process.
Validations make audits easy and comfortable by following the steady processes.
Process validation allows for minimizing the process control and product analysis requirement.
Process validation reduces the quality difference between two or more batches.
Validation reduces the wastage of materials during manufacturing processes.
It reduces the reprocessing work and thus improves output production.
Minimize the failure of any product at the finished stage of the product.
There are many systems where Validation is a mandatory process, to meet up GMP compliances. Some most important areas are the HVAC system, Analytical Process validation, Cleaning of manufacturing machinery’s validation, Water system, and Computer systems. All the above said systems are must-have validation plans for their process to produce quality products.
These days every regulatory department demands a Valid Master Validation plan for the different processes. FDA, MHRA, TGA, Schedule M, WHO-GMP, and every export country.
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