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…
Tag: Quality Assurance
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…
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…
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…
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…
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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