One aspect of pharmaceutical quality assurance that is very important, and that anyone working in the industry should be aware of, is technical writing. Technical writing is different from other kinds of writing, because it is focused first and foremost on clarity. Long sentences and descriptions might work well in an article or book, but not for a piece of technical writing. Whether you find yourself working with Standard Operation Procedures (SOPs), Master Batch Records (MBRs), or other pieces of writing, clarity and accuracy will be essential. With a few helpful hints, you’ll be on track to writing these documents.. READ MORE »
Wonder how change management fits into quality assurance courses and risk assessment? Learn more as you begin to prepare for a rewarding career in this field!
What is Quality by Design (QbD)? It’s an approach to pharmaceutical product development, where an objective is defined prior to starting the process and quality is instilled before manufacturing. Risk assessment and management are a priority and are used as the basis for process control. This can help to: Shorten development times Improve manufacturing quality Further assure safety and efficacy of pharmaceutical products While it takes more time at the beginning of a process, it allows for less stop-and-start along the rest of the development journey. Quality is implemented directly into the workflow, taking into account how the product’s characteristics.. READ MORE »
Continuous manufacturing is a method of mass production, where the materials involved flow continuously, without interruption. It enables manufacturing to be constant, operating 24/7 except for occasional maintenance shutdowns. In contrast, the industry standard prior to now has been batch manufacturing, which separates the process into different steps, executed individually. Quality control is an important part of the manufacturing process. Continuous manufacturing could affect it in a few ways—read on for more! 1. Continuous Manufacturing Needs Real Time Pharmaceutical Quality Control Differences in quality control for batch manufacturing vs. continuous manufacturing include the following: Since batch manufacturing allows for testing.. READ MORE »
Digitization is causing major changes in pharmaceutical quality assurance and quality control. Here are 3 changes pharmaceutical students should know about.
SUPAC is an important FDA guideline that students in quality assurance courses should know about. Check out why SUPAC matters to pharmaceutical manufacturing.
Interested in pharmaceutical quality assurance? Find out how the World Health Organization plays a key role in developing global quality assurance standards.
Students in pharmaceutical school take note: pill regimens and daily injections could soon be replaced with advanced medical implants that do the dosing for you.
A profession in the pharmaceutical sector means complying with responsibilities and guidelines that ensure the safety and effectiveness of drugs and medical devices. Since these guidelines aim at reducing and preventing errors, it is a process that demands diligence and integrity since professionals must consistently adhere to high standards. There are a number of guidelines and procedures that must be followed and monitored in order to strengthen both the manufacturing process and end-user delivery. Quality assurance professionals work at the heart of this, helping to ensure that standards are adhered to throughout facilities. They may even help train staff on.. READ MORE »
Aspirin is a popular medication used for a variety of conditions. Throughout its significant history, it has become a trusted option for the public to turn to when faced with ailments such as pain, migraines, and inflammation. As professionals working in the medical industry may know, nearly 100 billion tablets are ingested each year. With many benefits surrounding this common medication, Aspirin has a significant story behind its development. For students considering a career in the pharmaceutical industry, here is a summary of this impressive history. The Early History of Aspirin for Students in Pharmaceutical Courses Long before its approval.. READ MORE »