In your pharmaceutical quality assurance career, you may from time to time encounter issues that impact a drug’s quality and performance. Health Canada recognizes this reality, and has outlined steps that pharmaceutical companies must take to deal with these issues in its good manufacturing practices guide for drug products. However, delivering detailed investigation reports shortly after a deviation occurs is not an easy task. That’s why it’s important to fully understand these reports, so that you’re well-equipped to deal with manufacturing inconsistencies when they arise. Ready to get started? Read on to learn all about deviation investigation reports! What Is.. READ MORE »
Biotechnology has been a part of human life for centuries and also plays a major role in the pharmaceutical industry today. Typically referred to as biologics or biologic drugs, these products are developed, researched, and used by medical professionals all over the world. Similar to chemically developed drugs, biologics undergo strict regulation to make it to clinical trials and eventually to the market, or into medical facilities. Keep reading for more details about this important sector of the pharmaceutical industry. Biologics and Biotechnology Biotechnology companies exist in a range of industries, including food production, cleaning products, and the manufacture of.. 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 »
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 »
Interested in pharmaceutical quality assurance? Find out how the World Health Organization plays a key role in developing global quality assurance standards.
The world of pharmaceuticals is full of intense competition and exciting advances, but the balance sheets of the big industry players don’t always fully reflect that reality. It’s common for companies to coast along on the strength of past, lucrative accomplishments, with newer drugs and treatments accounting for a very small piece of their yearly earnings. Industry examiners, however, tend not to be as concerned with what companies once did. Instead, in the eternal effort to figure out who is doing the most that is new and exciting, they might turn to the “Freshness Index.” Curious about what this index.. READ MORE »
Are you considering returning to college after a long hiatus? Whether you want to upgrade your skillset to get promoted to your dream role, make a complete career switch, or modernize your knowledge in your field, it’s never too late to return to learning. Naturally, many adult learners are concerned about their study skills and ability to succeed in a learning environment after so much time away from the classroom. However, as an adult learner, you have a unique advantage. Your life experience and previous career and educational endeavors will be an asset in your ability to succeed. As for.. READ MORE »
It is estimated by the Alzheimer Society of Canada that about 564,000 Canadians will suffer from dementia in 2016. Medical professionals will diagnose an additional 25,000 cases every single year, and by 2031 it is believed the number of patients suffering from dementia will rise to 937,000. Dementia is a huge problem not only in Canada, but across the globe. Unfortunately, there haven’t been any significant scientific breakthroughs that could slow the progress of the disease—until now. If you’re a student enrolled in a pharmaceutical program, you may understand the groundbreaking impact this scientific breakthrough could bring to dementia patients… READ MORE »
In 2009, the swine flu pandemic swept across the world. Everybody panicked and once vaccines became available, people jumped at the opportunity to take them to inoculate themselves from contracting the virus. However, in the seven years since, it has come to light that declaring the swine flu a ‘pandemic’ was questionable at best. What was once considered a legitimate health threat, backed up by increasing death tolls that incited panic, is now considered a relatively ‘mild’ strain of the flu. Given how much the scare was amplified by the reactions of governing bodies as well as the population in.. READ MORE »
The pan-Canadian Pharmaceutical Alliance (pCPA) includes all 13 provinces and territories, as well as the Federal Government, and negotiates to decrease the price of both generic and brand name drugs for Canadians. According to the Canadian Institute for Health Information, Canadians spent $28.8 billion on prescription drugs in 2014, and this spending is actually down from the $33 billion Canadians spent in 2012. The CIHI also notes that the growth rate of Canadian pharmaceutical spending is quite low. This may all be due to effective negotiation measures taken by the pCPA. Read on to discover how the pCPA makes sure.. READ MORE »