SUMMARY: Ensure the integrity of pharmaceutical products through meticulous planning and execution of temperature mapping studies, involving precise sensor placements and data analysis, complemented...
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SUMMARY: Shipping validation per FDA guidelines requires meticulous adherence to documented procedures and temperature control measures to maintain product integrity throughout transit. Companies...
Commissioning vs Qualification vs Validation: A Comprehensive Guide to Pharma Processes
SUMMARY: Commissioning, qualification, and validation are integral processes in the pharmaceutical industry, each bearing its unique role and importance. Commissioning sets up and checks the...
Understanding IQ, OQ, and PQ: A Comprehensive Guide to Quality Control
SUMMARY: In the quality control world, IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) are key components. IQ involves checks before product...
What is a Validation Master Plan: An In-Depth Guide for Organizational Success
SUMMARY: A Validation Master Plan is a document that outlines an organization's approach to validation, including its scope, roles, and responsibilities, processes, and timelines. To write one,...
How To Qualify a Refrigerator: A Complete Guide for Pharmaceuticals and Biotech Industries
SUMMARY: Refrigerator qualification, particularly in pharmaceutical and biotech fields, involves a rigorous process to meet industry-specific requirements. It begins with understanding the...