Posts

Interview Question and Answers for Quality Control in Pharma industry

Image
  Interview Question and Answers for Quality Control in Pharmaceutical Industry Are you looking for the job in pharmaceutical industry in quality control department? If yes then here is some frequently asked question and answers that may help you in your interview preparations. The quality control department of any pharmaceutical industry consists mainly of following subdivisions to check the quality of the product at each step of manufacturing. 1.        Raw material 2.       Packing material 3.       Process Validation 4.       Finished Product 5.       Stability Studies 6.       Microbiology Studies Raw material is the base of any product manufacturing. A good quality raw material will definitely can produce a good quality product. Hence it is necessary to check the quality of Active pharmaceutical ingredients and excipients used for production. This post includes some basics that one should know before appearing for the interview of raw material section. If you
Post a Comment
Read more

Methods of Impurities Calculation

Image
  Methods of Impurities Calculation According to ICH guidelines impurities can be broadly classified into three categories as   Organic Impurities, Inorganic Impurities and Residual Solvents.  Related substances are defined as impurities derived from the drug substance and therefore not including impurities from excipients. Related substances include degradation products, synthetic impurities of drug substance and manufacturing process impurities from the drug product. Various concepts are used for the quantitation of impurities which are elaborated in this article.   The following calculation approaches can be used: 1.       External standard approach against quantitative RS for impurities. In this method quantitation is performed against an external standard of impurity itself. An external standard also serves as positive impurity peak identification rather than relying on relative retention times which are subject to reliability. Quantitation of impurities using this method pr
Post a Comment
Read more