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ENVIRONMENTAL FAILURE (STEPS TO BE TAKEN IN CASE) PURPOSE: To lay down a procedure for steps to be taken in case of environmental failure. SCOPE: This SOP is applicable for steps to be taken in case of environmental failure in Dry Powder Injection section. RESPONSIBILITY: Preparation of SOPs: Officer/ Executive of Production Departments Checking and … Read more

Design Qualification (DQ) Protocol Form Fill Seal Blow-Fill-Seal (BFS) technology is a manufacturing technique used to produce small, (0.1mL) and large volume, (500mL +) liquid-filled containers. The basic concept of BFS is that a container is formed, filled, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. … Read more

CHECKLIST FOR PREVENTIVE MAINTENANCE OF COMPRESSION MACHINE Equipment code: ___________________________ Frequency:  Quarterly Open and clean the panel internally and externally using vacuum cleaner/air blower. Visually check the tightness of cable termination at MCCB incoming and outgoing side and at outgoing MCB. Check the operation and setting of all machine interlocking. Check all terminations for overheating. … Read more

SOP FOR PROCEDURE FOR STABILITY STUDY OF FINISH PRODUCT PURPOSE: The purpose of this SOP is to describe a procedure for stability study of Finish products. SCOPE: This SOP is Applicable for stability study of Finish products. RESPONSIBILITY: QA personnel shall be responsible for the preparation of the SOP and stability protocol. QA personnel shall … Read more

SOP on Preparation, Approval, Review and Control of Operating Guidelines Objective : To lay down a procedure for the preparation, approval, review and control of Operating Guidelines. Scope : This Standard Operating Procedure is applicable for the preparation and implementation of all Operating Guidelines.  Responsibility :HODs of respective department shall be responsible for preparation of Operating … Read more