quality and stability of drugs and medicines

• To learn various factors affecting stability of drugs and medicines and importance of quality assurance in safeguarding against risks • To understand nature of degradation of API and how stabilisers and storage conditions help minimise some of the concerns • To introduce likely instability issues with protein/peptide drugs • To learn how shelf-life of a drug is estimated and why it would differ by climate zones

what is the stability of Drugs

Understanding various factors affecting the stability of drugs and medicines, and the importance of quality assurance in mitigating risks.

Degradation of API

Exploring the nature of degradation of Active Pharmaceutical Ingredients (API) and how stabilizers and storage conditions help minimize concerns.

what is quality assurance

a wide range concept covering all matters that influence the quality of a product

what is good manufacturing

practice ensures that products are produced and controlled to meet appropriate quality standards

what is quality control

a process dedicated to sample, test and specify materials at each level of manufacturing, determining if they met the requirements

what is Protein/Peptide Drugs Instability

instability issues associated with protein/peptide drugs.

what is shelf-life Estimation

Learning how the shelf-life of a drug is estimated and why it varies across different climate zones.

what is documentation in quality assurance important

Importance of maintaining extensive documentation as a critical part of quality assurance to trace the complete history of a batch.

Standard Quality Requirements

Key requirements including identity, purity, strength, uniformity, bioavailability, and stability of pharmaceutical products.

Pre-formulation Assessment

Evaluating factors like susceptibility to degradation reactions, drug-excipient interactions, reaction mechanisms, and shelf-life through accelerated stability testing.

Definition shelf life

The length of time a pharmaceutical product remains stable and fit for its intended purpose.

Causes of Chemical Instability

Understanding factors like hydrolysis, oxidation, dimerization, polymerization, isomeric changes, and photodegradation affecting drug stability.