Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Process Validation: An Overview


Affiliations
1 Department of Pharmaceutical Sciences, Manav Bharti University, Solan (H.P.), India
     

   Subscribe/Renew Journal


Validation is an act of demonstrating a procedure, process, and activity which will consistently lead to the expected results. In pharmaceuticals there are wide varieties of procedures and processes which need to be validated. The validation process consists of identifying and testing all aspects of a process that could affect the final test or product. Prior to the testing of a process, the system must be properly qualified. A properly designed system will provide a high degree of assurance in order to evaluate every step, process and change before its implementation. In this paper, statistical issues, regulatory requirements required for process validation options in drug development are discussed.

Keywords

Process Validation, cGMPs, Pilot Scale-Up, Validation Options, Statistical Issues.
Subscription Login to verify subscription
User
Notifications
Font Size


Abstract Views: 264

PDF Views: 0




  • Process Validation: An Overview

Abstract Views: 264  |  PDF Views: 0

Authors

Deepak Prashar
Department of Pharmaceutical Sciences, Manav Bharti University, Solan (H.P.), India

Abstract


Validation is an act of demonstrating a procedure, process, and activity which will consistently lead to the expected results. In pharmaceuticals there are wide varieties of procedures and processes which need to be validated. The validation process consists of identifying and testing all aspects of a process that could affect the final test or product. Prior to the testing of a process, the system must be properly qualified. A properly designed system will provide a high degree of assurance in order to evaluate every step, process and change before its implementation. In this paper, statistical issues, regulatory requirements required for process validation options in drug development are discussed.

Keywords


Process Validation, cGMPs, Pilot Scale-Up, Validation Options, Statistical Issues.