Brief explain process validation types…
Process validation is applicable when ever made changes in process, new process or validation batches, each test as BMR from Chang to end product, example : drying process as BMR lod test required after 4hrs drying, but in validation need to check lod of wet cake, 1hrs, 2hrs,… and also before drying and different points in drying…
Process Validation has mainly four types:
3.Concurrent Validation and
Even i agree with the answer of mr.ajay
Can you explain about this 4types for better understanding
Process Validation guidelines.pdf (74.0 KB)
It’s contains in detail…
Types of process validation
Depending on when it is performed in relation to production, validation can be prospective, concurrent,
retrospective and revalidation (repeated validation).
Prospective validation :
During the development stage by means of a risk analysis of the production process.
This method is effective only if the development stage has resulted in a proper understanding of the fundamentals of the process. The first three production-scale batches must be onitored as comprehensively as possible. The nature and specifications of subsequent in-process and final tests are based on the evaluation of the results of such monitoring.
Retrospective validation :
Retrospective validation is obviously not a quality assurance measure in itself, and should never be applied to new processes or products. It may be considered in special circumstances only, e.g. when validation requirements are first introduced in a company. Retrospective validation may then be useful in establishing the priorities for the validation program. If the results of a retrospective validation are positive, this indicates that the process is not in need of immediate attention and may be validated in accordance with the normal schedule.
Revalidation is needed to ensure that changes in the process and/or in the process environment, whether intentional or unintentional, do not adversely affect process characteristics and product quality.
Revalidation may be divided into two broad categories :
Revalidation after any change having a bearing on product quality. Periodic revalidation carried out at scheduled intervals.