AN OVERVIEW ON CLINICAL TRIALS

Introduction:- Developers of drugs, biologicals, and medical devices must ensure product safety, demonstrate medical benefit in…

TESTING OF DISINFECTANTS

Disinfectants used in hospitals and laboratories must be tested periodically to ascertain its potency and efficacy.…

DEFINITIONS AS PER CGMP

Production/manufacturing:– All operations involved in obtaining a product from the receipt of materials through processing to…

MICROBIAL ENUMERATION TESTS

The tests described hereafter will allow quantitative enumeration of mesophilic bacteria and fungi that may grow…

QUALITY RISK MANAGEMENT

Quality Risk Management (QRM) gives the possibility of determining the impact of a deviation in a…

ANALYTICAL INSTRUMENT QUALIFICATION (AIQ)

AIQ is the collection of documented evidence that an instrument performs suitably for its intended purpose.…

HVAC SYSTEM VALIDATION TESTS

AIR FLOW PATTERN:- For determination of air flow pattern, a titanium tetrachloride stick is burnt and…

EVALUATION OF TABLETS

Size & Shape:It can be dimensionally described & controlled. The thickness of a tablet  is only variables.…

PHARMACEUTICAL WATER

A) Introduction Water is widely used as a raw material, ingredient, and solvent in the processing,…

SOP FOR DEPYROGENATION

1.0  OBJECTIVE : This procedure is laid down for depyrogenation of glass wares for Bacterial Endotoxin…