Tuesday, December 14, 2010

Why Validation is Important

Validation is a concept that has been evolving continuously since its first formal appearance in United States in 1978. The concept of validation has expanded through the years to encompass a wide range of activities which should take place at the conclusion of product development and at the beginning of commercial production. Validation is confirmation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled.
We all love validation!
We all love validation!

Objective Measures

Validation is the overall expression for a sequence of activities in order to demonstrate and document that a specific product can be reliably manufactured by the designed process, usually, depending on the complexity of today’s pharmaceutical products, the manufacturer must ensure. Quality cannot be adequately assured merely by in-process and finished product inspection or testing so the firms should employ objective measures (e.g. validation) wherever feasible and meaningful to achieve adequate assurance.
Today we have different definitions of validation, which are as follows-
  • Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.
  • The collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
  • Validation is a process by which a procedure is evaluated to determine its efficacy and reliability for forensic casework analysis.

Why Validation is Important

The principles – Quality, Safety and Effectiveness must be designed and built in to the product, quality cannot be inspected or tested in the finished products and each step of the manufacturing process must be controlled to maximize the probability that the finished product meets all quality and design specifications. Now let me explain the specific importance of the validation – it is the concept detailed in quality guidelines of Product Lifecycle and with the help of which we can do the following:
  • Determine the process parameters and necessary controls.
  • To confirm the process design as capable of reproducible commercial manufacturing.
  • Risk/Worst Case assessment. What is Worst Case? It is a set of conditions encompassing upper and lower limits and circumstances, including those within standard operating procedures, which pose the greatest change of process or product failure when compared to the ideal conditions.
  • To provide ongoing assurance that the process remains in a state of control during routine production through quality procedures and continuous improvement initiatives.
  • Quantitatively determine the variability of a process and its control.
  • The variability within and between batches can be evaluated to determine the inner and intra-batch variability.
  • Greater scrutiny of the process performance for development and deployment of process controls.
  • Scientific study performed prior to implementing a change to a process can support the implementation of a change without revalidation.
  • Safeguard and process against sources of variation which may not have been identified during the original process development.
  • The most compelling reason to optimize and validate pharmaceutical productions and supporting processes and cost reduction.
  • Control point in the context of preventive maintenance.
  • Investigate deviations if any from established parameters.


Validation allows us to focus on our everyday business operations of making and selling quality products that also comply with regulatory requirements such as the FDA, Schedule M, etc. The industry which has adopted a lifecycle approach to the product development, validation and modern risk analysis tools can control critical process parameters. The companies can create a new standard of industry best practice by embracing the ability of validation practices which will lead in technological revolution.

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