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Category / Validation

Validation

Pharmaceutical Validation is the most recognized and important parameter of GMPs. Quality cannot be ensured by sampling, testing, release of materials and products. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. Process validation of a process will ensure production of drug of reproducible quality. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.

The main reasons for pharmaceutical validation are-

  1. Quality assurance: Quality cannot be assured by daily quality control testing because of the limitations of statistical samples and the limited facilities of finished product testing. Validation checks the accuracy and reliability of a system or a process to meet the predetermined criteria. A successful validation provides high degree of assurance that a consistent level of quality is maintained in each unit of the finished product from one batch to another batch.
  2. Economics: Due to successful validation, there is a decrease in the sampling and testing procedures and there are less number of product rejections and retesting. This lead to cost-saving benefits.
  3. Compliance: For compliance to current good manufacturing practices CGMPs, validation is essential.

Below is a list of suppliers who specialise in providing services related to Validation:

Validation Products