POURED AND TAPPED BULK DENSITY
Introduction:- The poured and tapped bulk density techniques are used to characterize powder flow-ability. Poured bulk density is determined by pouring a sample of known…
IND, NDA AND ANDA DRUG EVOLUTION PROCESS
The Federal Food, Drug and Cosmetics act regulated through Title 21 of U.S Code of federal Regulations, requires a new drug to be approved by…
TESTING OF PHARMACEUTICAL PACKAGING MATERIALS
QUALITY CONTROL TESTS FOR GLASSES Chemical Resistance Of Glass Containers:- Powdered Glass Test:- It is done to estimate the amount of alkali leached from the…
STABILITY STUDIES IN DRUG DEVELOPMENT PROCESS 1
INTRODUCTION:- Stability study is a vital stake of the drug development process. Stability is the only way that assures whether the drug is within acceptance…
QUALIFICATION OF TUNNEL STERILIZING MACHINE
Depyrogenation devices, such as tunnels, are used in the pharmaceutical industry to prepare components for aseptic filling. To qualify such devices, various pharmacopoeias require depyrogenation…
POWDER FINENESS AND SIEVES
POWDERS: – The degree of coarseness or fineness of a powder is differentiated by the nominal aperture size of the mesh of the sieve through…
QUALIFIED PERSONS AS PER EUROPEAN PHARMACEUTICAL REGULATIONS
Qualified person (QP):- It is a technical term used in European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use). The regulations specify…
AN OVERVIEW ON CLINICAL TRIALS
Introduction:- Developers of drugs, biologicals, and medical devices must ensure product safety, demonstrate medical benefit in people, and mass produce the product. Preclinical development starts…
TESTING OF DISINFECTANTS
Disinfectants used in hospitals and laboratories must be tested periodically to ascertain its potency and efficacy. As certain disinfectants lose potency on standing and addition…
DEFINITIONS AS PER CGMP
Production/manufacturing:– All operations involved in obtaining a product from the receipt of materials through processing to packaging and labelling. Quality Control Unit:- It is the…
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