HPLC Calibration Procedure as per IP
Standard Operating Procedure (SOP) and format/Protocol of HPLC system calibration as per newly released Indian Pharmacopoeia (IP) recommendations. This Procedure… Read More
Analytical Method Validation (AMV) – ICH Q2R1 Guideline – SOP
Standard Operating Procedure and Guideline for Analytical Method Validation (AMV) for Oral solid dosage form as per ICH - Q2… Read More
Identification of Worst case in Cleaning Validation
Cleaning is a crucial step in the manufacturing of pharmaceutical products, and it is essential to validate that the equipment… Read More
Calibration of Instrument / Equipment Policy
Calibration Policy/SOP - Instrument calibration isĀ one of the primary processes used to maintain instrument accuracy. Calibration is the process of… Read More
Media Fill Validation Procedure & Guideline
A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of… Read More
Work Permit System (Safety)
Safety work permit is a written record that authorizes specific work, at a specific location, for a specific time period.… Read More
Monitoring of Ambient Air Quality and Stack
Standard Operating Procedure for Monitoring of Ambient Air Quality and Stack Monitoring or Stack sampling for evaluating the characteristics of… Read More
Top Loading Balance – Operation and Calibration SOP
Standard Operating Procedure for Operation and Calibration of Top Loading Balance used in the pharmaceutical industry, guideline, and formats of… Read More
Data Integrity Incident Handling Procedure
Standard Operating Procedure (SOP) for Handling of Data Integrity Incident Investigation and compliance in Pharmaceutical Drug Manufacturing Plant. Handling of… Read More
Transport Validation – Guideline & Protocol
Standard Operating Procedure (SOP) and Protocol for Transport Validation through temperature mapping during transit of drug products. Transport Validation Procedure… Read More