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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 FDA before legally getting introduced into the market. In...

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 criteria or not. Stability comes into focus when the...

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 devices to be periodically challenged with high levels of...

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 that no batch of medicinal product can be released...

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 before clinical trials and the main goals are to...

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 department designated as responsible for the certification of quality of...

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 to categorise it and facilitate its treatment. ICH Q9...

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 confidence in the validity of generated data. PHASES OF QUALIFICATION ...

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