Author(s): Prakash Choudhary, Ramakant Sharma, Jeevan Patel, Shabnam Khan and Dr. Rakesh Patel

Abstract: To develop a process validation protocol for establishing documented evidence to ensure that process variables including the critical process parameters are under control and to demonstrate that the process consistently produces product meeting its predetermined specifications and quality attributes. To perform Concurrent process validation for Abiraterone Acetate Tablets USP 250 mg. The protocol describes the different process stages, control variables & measuring responses with justification, sampling plan, acceptance criteria the process of manufacturing of abiraterone acetate tablets up 250 mg as per manufacturing document, master card for batch no. abir01, abir02 and abir03 were validated and approved as per this validation report on the basis of statistical analysis of all critical process & mixing, compression and packing parameters, it is concluded that manufacturing process is robust and hence, stands validated.

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