Monday, July 13, 2020

How to Write a Validation Protocol?

A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report and...

Assigning Manufacturing and Expiry Date

Objective: To lay down a procedure for assigning manufacturing and expiry date to the finished products being manufactured. Scope: This SOP is applicable for assigning manufacturing and...

Technology Transfer Sample Protocol in Pharmaceuticals

In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to...

VMP (Validation Master Plan) Preparation Guideline in Pharmaceuticals

Validation Master Plan VMP is a roadmap of validation activity like facility qualification and also define system and area to be validated. VMP justifies the...

SOP for Code to Code Transfer of Materials and Additional Testing of Materials /...

Objective To lay down a procedure for code transfer of same material from one code to another and to carry out additional testing of APIs,...