According to Indian GMP validation study is essential part of GMP. Those required to be done as per predetermined protocols. Prospective process validation1, 2 is carried out during the development stage by means of risk analysis of the production process which is broken down into individual steps. These are then evaluated on basis of past experience to determine whether they might lead to critical3,4 situation are identified, the risk is evaluated, the potential cause are
investigated and assessed for probability & extent, the teal plan are drawn up, & priorities are set The trial are then performed and evaluated & overall assessment is made. If at the end results5 are acceptable the process is satisfactory. Unsatisfactory processes must be modified & improved until a validation exercise proves them to be satisfactory this form of validation is essential in order to limit the risk of error occurring on the production scale. This present work deals with identification of critical stage and their consequent evaluation by challenging its upper and lower specifications.
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