Bremen

SOP FOR OPERATION AND CALIBRATION OF pH METER PURPOSE: To lay down a procedure for Operation and Calibration of pH… Read More

SOP FOR RESPONSIBILITY OF QA PERSON PURPOSE: To lay down the responsibilities of the Quality Assurance Department. SCOPE: This procedure… Read More

SOP FOR PROCEDURE FOR DESTRUCTION OF WASTE MATERIAL PURPOSE: To lay down a procedure to be followed for the Destruction… Read More

SOP ON IMPACT ASSESSMENT FOR EQUIPMENT /SYSTEM OBJECTIVE: To assess the impact of process variables on quality of product prior… Read More

SOP FOR HANDLING OF REPROCESSING AND REWORKING OBJECTIVE: To describe a procedure for reworking and reprocessing of the batch. SCOPE:… Read More

RISK ASSESSMENT PROTOCOL FOR DEPYROGENATION TUNNEL To establish documented evidence that the design of in–use “Vial Filling and rubber stoppering… Read More

Procedure-for-calibration-of-calculator-quality-assurance/Validation of digital Calculator Objective: The purpose of this SOP is to lay down a procedure for validation of digital calculator.… Read More

ENVIRONMENTAL MONITORING BY SETTLE PLATE METHOD OBJECTIVE: To lay down a procedure Environmental monitoring by settle plate method. SCOPE: This SOP is… Read More

ENVIRONMENTAL MONITORING BY AIR SAMPLING METHOD OBJECTIVE: To lay down a procedure Environmental monitoring by Air sampling method. SCOPE: This SOP is… Read More

Personal monitoring by contact plate method in sterility testing area. OBJECTIVE:  To lay down a standard operating procedure for personal monitoring… Read More