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