Overview 1.Fish bone diagram is a tool which is used to identify the root cause of the problem. The fish bone diagram is also called as Ishikawa diagram based on its pioneer Kaoru Ishikawa, a Japanese Engineering professor. He is noted for his quality management innovations and considered a key figure in the development of quality initiatives […]
Concept 1.The drug injections/infusions that are manufactured in the pharmaceuticals are tested for sterility for every lot/batch. Sterility testing is performed to check the drug injections/infusions that are released to the market as “STERILE” i.e., they are free from microorganisms. Any drug injections/infusions that reach the blood system should be sterile or else the contaminated […]
Rabbits were used for the pyrogen testing from 1940’s and were replaced with LAL testing from 1977. For LAL testing [Bacterial endotoxins], the blood of horse shoe crabs are used to till date. LAL testing continues to serve as an efficient and reliable safety test for human and animal injectable drugs. LAL test prevails in the pharmaceutical […]
What are residual solvents in a drug? Residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. The solvents are not completely removed by the manufacturing techniques. The content of solvents in such products should be evaluated and justified. Appropriate selection of […]
Like the holy books in every religion, the ALCOA principles should be the holy books in all pharmaceutical and medical device manufacturing facilities all over the world. All the data, the research work, clinical trial data, validation / qualification data, manufacturing batch record, monitoring records etc. are equally important and they form the foundation of […]
Harishchandra was a legendary Indian king. He gave away his kingdom, sold his family and agreed to be a slave to fulfill a promise he had made to the sage Vishwamitra. While employed in a cremation ground, Harishchandra told her wife that he would cremate his dead son only after getting the cremation fee. He was honest […]
Indicator An indicator is an observable characteristic that can be used to show changes toward achieving a specific outcome. Chemical indicator Chemical indicator undergoes an observable change when conditions change. This could be a color change, temperature change, or other measurable quality. Benefits of using chemical indicators for Sterilization These chemical indicators are used in sterilizers in […]
Who are they? Drug regulatory agencies or authorities are responsible in effective drug regulation to ensure the safety, efficacy and quality of drugs, as well as the accuracy and appropriateness of the drug information available to the public. The most highly regulated industries worldwide are Pharmaceuticals. These agencies or authorities ensure the compliances in legal […]