level: Level 1
Questions and Answers List
level questions: Level 1
| Question | Answer |
|---|---|
| A measure of how pharmaceutical products maintains its quality attribute over time | Drug Stability |
| Objective of Stability Testing | to provide evidence on how the quality of a drug substance or drug product VARIES WITH TIME under the influence of a variety of environmental factors such as TEMEPRATURE, HUMIDITY AND LIGHT, & enables recommended STORAGE CONDITIONS, RE-TEST PERIODS & SHELF LIVES to be established |
| Variable affecting stability | 1 Formulation 2 Packaging 3 Site and method of manufacture - API - Finished product 4 Batch size 5 Batch to batch variability - Process validation - Quality risk management 6 Container labelling 7 Changes to product |
| Adverse effects of instability of drugs | 1 Loss of active drug 2 Loss of vehicle 3 Loss of content uniformity 4 Loss of elegance 5 Reduction of bioavailability 6 Production of Potential toxic materials |
| TYPES OF STABILITY | 1 Microbiological Stability 2 Physical Stability 3 Toxicologic Stability 4 Chemical Stability 5 Therapeutical Stability |
| Each active ingredient retains its chemical integrity and labeled potency within the specified limit | Chemical Stability |
| Stability properties includes appearance, palatability, uniformity, dissolution, and suspendability are retained | Physical Stability |
| Sterility or resistance to microbial growth is retained according to specified requirement | Microbiological Stability |
| Therapeutic activity remains unchanged | Therapeutic Stability |
| No significant increase in toxicity occurs | Toxicologic |
| Characterise compatibility with common excipients Characterise stability profile API Characterise stability profile of early formulations | Development studies |
| Long term & accelerated studies on the product as it is to be registered | Confirmatory studies |