Workshop on General Accident Prevention at The workplaces.pdf

Market Complaint.pdf

Good Documentation Practice (GDocP).pdf

GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Reference: WHO) In contrast, cGMP i.e. ‘c’ before the GMP is indicative of the constantly changing technologies and systems which are up-to-date in order to comply with the regulations. These the dynamic changes in Good Manufacturing Practice to make Pharmaceuticals manufacture foul proof; assuring a high level of confidence in the safety and efficacy of the product.

Current Good Manufacturing Practice (cGMP)

Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. The first generation of biological drugs, which have introduced many revolutionary treatments to life threatening and rare illnesses, is currently facing patent expiration. As a result, research-based and generics pharmaceutical companies alike are pursuing the opportunity to develop “generic” substitutes to original biologics, which are also known as biosimilars.

Bio-equivalence and Bio-similarity studies of Drugs

Good Clinical Practice and Pharmacovigilance

Stability study of Pharmaceutical Products and Regulatory Requirements

Post-marketing drug safety surveillance refers to the monitoring of drugs once they reach the market after clinical trials through a process which evaluates drugs taken by individuals under a wide range of circumstances over an extended period. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

Post Marketing Drug Safety & Pharmacovigilance

Drug Development and Clinical Studies

Electronic Common Technical Document (eCTD)

PRODUCT REGISTRATION IN THE GLOBAL MARKET WITH CTD

Pharmaceutical Quality by Design (QbD)

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Product Recall.pdf

Market Complaint.pdf

Good Documentation Practice (GDocP).pdf

Current Good Manufacturing Practice (cGMP)

Bio-equivalence and Bio-similarity studies of Drugs

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