FDA Warning Letters for Cleaning Validation

FDA Warning Letters for Cleaning Validation

FDA Warning Letters for Cleaning Validation The FDA frequently issues Warning Letters to pharmaceutical manufacturers for deficiencies in cleaning validation programs, as inadequate cleaning can lead to cross-contamination, adulteration, and patient safety risks....
Quality Management System (QMS)

Quality Management System (QMS)

Quality Management System (QMS) 1. Definition A Quality Management System (QMS) is a structured framework of policies, procedures, processes, and resources that ensures pharmaceutical products consistently meet quality, safety, efficacy, and regulatory requirements.It...
Calibration of Friability Test Apparatus

Calibration of Friability Test Apparatus

Calibration of Friability Test Apparatus 1. Introduction The friability test determines the ability of uncoated tablets to resist mechanical stress during handling, packaging, and transportation. The friability test apparatus (e.g., Roche Fryolator) rotates tablets in...
UV Cabinet Calibration in Pharmaceuticals

UV Cabinet Calibration in Pharmaceuticals

UV Cabinet Calibration in Pharmaceuticals 1. Introduction A UV Cabinet (also called a UV viewing cabinet or UV inspection chamber) is used in pharmaceutical laboratories for visual inspection of materials—especially for thin-layer chromatography (TLC) plates,...
Calibration of Refractometer

Calibration of Refractometer

Calibration of Refractometer 1. Introduction A refractometer is used in pharmaceutical, food, and chemical industries to measure the refractive index (RI) of liquids, which is related to concentration or purity. Calibration ensures measurement accuracy and compliance...

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