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 […]
Types of Testing for COVID 1.Diagnostic tests are of two categories – Molecular [RT-PCR] and rapid tests [Antigen test]. 2. Antibody tests [ELISA test]. About RT-PCR test RT PCR means Reverse-Transcriptase-Polymerase Chain Reaction. RT–PCR is one of the most widely used laboratory methods for detecting the COVID-19 virus.A virus has an outer molecular envelope like […]
Introduction: Steam Heat Sterilizer is an equipment used for sterilizing articles / products / aids / medical equipment for destroying viable microorganisms by moist sterilization. Bowie Dick test could assess inadequate vacuum, meaning inadequate air removal from the sterilizer chamber or a leaky door gasket that would also allow for residual air in the sterilizer […]
Invariably the instant answer would be a “Startled No” and immediately lot of butterflies would start flying in our belly. The reason being, we are not prepared and equipped to speak before an audience / public. I remember a joke, when a group of tourists visit the Niagara Falls and are accompanied by a guide. […]
Introduction Sounds easy and everyone would say-yes, I do have. We live in the very fast paced world and we do not have time to see both our professional and personal lives in a microscopic way. Parenting skills are like all other skills which we develop during the upbringing of our children but the question […]
Corona virus took the world like a Tsunami in 2020 before anyone could understand the devastation of lives and its far reaching impact in everyone’s life in this earth-the present and the future. Since the Virus is highly microscopic in nature, there are still doubts in the minds, whether there exists Corona Virus? or simply […]