Pharmaceutical scientists started to recognize the importance of dissolution testing in the 1950s. During that decade, theories about the absorption of drugs like aspirin into the bloodstream were starting to be more widely understood. However, studies involving dissolution began as early as 1897 with Noyes and Whitney. Today, dissolution testing plays an integral role in the development and approval of pharmaceutical products, especially generic oral dosage form drugs. It is an indispensable analytical test for drug regulations, quality control, and quality assurance. Keep reading to learn more about how these tests work throughout the life cycle of pharmaceuticals… READ MORE »
According to Health Canada, fruits and vegetables are the best food sources of vitamin C. Things like red cabbage, strawberries, and citrus fruits have this vitamin, which helps the body absorb iron, heal wounds, and acts as an antioxidant. How else can people get vitamin C? This natural health product is also available in tablet form. Other Natural Health Products (NHPs) include: Herbal remedies Homeopathic medicines Probiotics Amino acids Much more NHPs are regulated by Health Canada to ensure that Canadians are getting safe, effective, and quality goods. How is the quality of NHPs assured and maintained? Keep reading to.. READ MORE »
Engaging the general public with what’s going on in the world of scientific research and quality assurance is important, if we are to raise awareness about issues in the science community. These issues can be difficult to communicate to the public, as often language is used that reaches past general knowledge and acts as a barrier to comprehension. Science communication helps to increase: public understanding; enthusiasm; and support Read on to learn more about why it’s so important! Quality Assurance Training Prepares You to Work with Different People If you’re looking forward to a career working in the sciences, you’ll.. READ MORE »
The Canada Food and Drugs Act is an important part of consumer safety in Canada. Whether hazards are accidental or caused by fraudulent behaviour, the statute protects people from these risks in food, drugs, medical devices, and cosmetics. The first version of the Food and Drugs Act came into effect in 1920, undergoing many revisions afterwards. This is important legislation, as it forms the basic core of food and drug safety laws in the country. In order to pursue a career involved in keeping standards high for these products, you should have an understanding of the act and its history… READ MORE »
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.