SOP ON IMPACT ASSESSMENT FOR EQUIPMENT /SYSTEM
SOP ON IMPACT ASSESSMENT FOR EQUIPMENT /SYSTEM OBJECTIVE: To assess the impact of process variables on quality of product prior…
SOP FOR HANDLING OF REPROCESSING AND REWORKING
SOP FOR HANDLING OF REPROCESSING AND REWORKING OBJECTIVE: To describe a procedure for reworking and reprocessing of the batch. SCOPE:…
RISK ASSESSMENT PROTOCOL FOR DEPYROGENATION TUNNEL
RISK ASSESSMENT PROTOCOL FOR DEPYROGENATION TUNNEL To establish documented evidence that the design of in–use “Vial Filling and rubber stoppering…
Procedure-for-calibration/Validation of digital Calculator
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…
ENVIRONMENTAL MONITORING BY SETTLE PLATE METHOD
ENVIRONMENTAL MONITORING BY SETTLE PLATE METHOD OBJECTIVE: To lay down a procedure Environmental monitoring by settle plate method. SCOPE: This…
ENVIRONMENTAL MONITORING BY AIR SAMPLING METHOD
ENVIRONMENTAL MONITORING BY AIR SAMPLING METHOD OBJECTIVE: To lay down a procedure Environmental monitoring by Air sampling method. SCOPE: This…
Personal monitoring by contact plate method in sterility testing area.
Personal monitoring by contact plate method in sterility testing area. OBJECTIVE: To lay down a standard operating procedure for personal…
SOP on container closure integrity for Dry powder for injection
SOP on container closure integrity for Dry powder for injection Objective : To lay down the procedure for container closure…
SOP on Handling of Returned Goods
SOP on Handling of Returned Goods Objective : To lay down the procedure for handling of returned goods from customer.…
SOP on Additional testing
SOP on Additional testing Objective: To lay down a procedure to carry out additional testing after necessary QA approval so…