MICROBIAL ENUMERATION TESTS
The tests described hereafter will allow quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions. If the product to be examined…
QUALITY RISK MANAGEMENT
Quality Risk Management (QRM) gives the possibility of determining the impact of a deviation in a process or product in an objective manner, in order…
ANALYTICAL INSTRUMENT QUALIFICATION (AIQ)
AIQ is the collection of documented evidence that an instrument performs suitably for its intended purpose. Use of a qualified instrument in analyses contributes to…
HVAC SYSTEM VALIDATION TESTS
AIR FLOW PATTERN:- For determination of air flow pattern, a titanium tetrachloride stick is burnt and placed in front of the AHU. The distribution of…
EVALUATION OF TABLETS
Size & Shape:It can be dimensionally described & controlled. The thickness of a tablet is only variables. Tablet thickness can be measured by micrometre or by…
PHARMACEUTICAL WATER
A) Introduction Water is widely used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients…
SOP FOR DEPYROGENATION
1.0 OBJECTIVE : This procedure is laid down for depyrogenation of glass wares for Bacterial Endotoxin test to make them free from any endotoxin and…
EXCIPIENTS USED IN TABLETS
Excipients are crucial to within the body. Generally, an excipient has no medicinal properties. Its standard purpose is to streamline the manufacture of the drug product…
ANALYTICAL INSTRUMENT QUALIFICATION (AIQ) 1
AIQ is the collection of documented evidence that an instrument performs suitably for its intended purpose. Use of a qualified instrument in analyses contributes to…
DRUG REGULATORY AFFAIRS AND ITS COMMON TERMINOLOGIES
Regulatory Affairs:- Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across…
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