Why Validation is Important!
; 26 August 2010
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!
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
; 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
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
; 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
; 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
; 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. Conclusion
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.
Rajkumar P. Patil
Sr. Production Officer
Mobile No. +919945642935
Mail ID. email@example.com
Critical Parameters Affecting Process Validation
; 27 September 2010
Validation is an integral part of quality assurance; it involves systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. Validation in itself does not improve processes but confirms that the processes have been properly developed and are under control. Adequate validation is beneficial to the manufacturer in many ways – It deepens the understanding of processes; decreases the risk of preventing problems, defect costs, regulatory non compliances and thus assures the smooth running of the process.