Q. When is it necessary to perform in-use stability studies on solid oral dosage forms such as tablets and capsules in multi-dose containers? Ans. Data on the in-use stability of such products should be generated through a dedicated in-use stability study under long-term conditions when there is an indication from stability and/or stress studies that…
Q. What is dissolution testing, and why is it important? Dissolution testing is a critical quality control measure in pharmaceutical manufacturing that evaluates how quickly an active pharmaceutical ingredient (API) releases from its dosage form. It ensures product efficacy, consistency, and patient safety. Q. What are the stages of dissolution testing? Dissolution testing occurs in…
Q: What is the bracketing approach in stability testing? A: The bracketing approach involves testing only samples at the extremes of specific factors, such as strength, container size, or fill volume. The assumption is that intermediate samples behave similarly to these extremes. Q: When is bracketing most effective? A: It works best when there is…
Q: What is the purpose of the weight variation test in pharmaceuticals? The weight variation test is an in-process check to ensure that the finished pharmaceutical product remains within the acceptable weight range. Q: How is the weight variation test conducted? The test involves weighing 20 tablets individually and calculating the average weight. The test…
Q. What is USP Apparatus 1? USP Apparatus 1 refers to baskets, which were the first standardized apparatus added to the USP. Q. How common is the use of baskets in dissolution testing? Baskets are the second most common apparatus used in methods today due to their versatility for various dosage forms. Q. When should…
Measuring the melting point of a substance is a critical quality control (QC) test in pharmaceuticals, as it helps to identify the substance and determine its purity. Here’s how melting point is typically measured in QC: Methods for Measuring Melting Point Equipment Used Procedure Calculations Reporting Results Regulatory Requirements Read also: Resource Person: Dhruv Jayswal
Q. Do we need to initiate an OOS investigation if OOS results are found during API Method Transfer? Ans: Yes, if it happens at the originating lab. If it happens at the receiving lab, handle it through a lab incident or deviation to identify the root cause as per in-house SOP; no OOS is needed….
A list of common interview questions and answers on stability testing of pharmaceutical products are given below: Q. What is stability in pharmaceuticals? Stability in pharmaceuticals refers to the ability of a drug product to maintain its physical, chemical, and microbiological properties within a specified range over a given period of time under the influence…
Quality control is a core department in a pharmaceutical industry, which act to ensure product quality through following GLP. Here we mentioned a list of questions and answers commonly asked during interview: Q. What is GLP? GLP means Good Laboratory Practice. It is a framework or pattern under which research work are planned, performed, monitored,…