The biotech industry experiences constant change with progressive knowledge and research emerging in the field every year. Because of these advancements, people are able to receive clearer diagnoses and find more effective treatment options for their conditions. A certification in regulatory affairs will allow you to enter the biotech industry with knowledge on a wide range of regulations and standards, such as: Regulatory submissions Post-approval activities Regulatory compliance The Canadian Food and Drugs Act Global Regulatory Strategies Students in this program will earn a certification covering 10 different modules to prepare them for a career in regulatory affairs. With extensive.. READ MORE »
Cleaning procedures are essential for preventing the contamination of manufacturing products. Those procedures must be well-documented, approved, and consistently performed by professionals to ensure the quality and safety of a product. Cleaning validation ensures that the facility and equipment are designed, used, and maintained in a manner that will remove by-products, cleaning agent residues, or microorganisms from new products. In the pharmaceutical industry, regulators expect to see a validation program with documented evidence that a process will consistently lead to a product that meets quality standards. In other words, the compliance, quality, and safety of drug products depend upon a.. READ MORE »
The pharmaceutical world is bound by a number of rules and regulations designed to ensure both quality and safety when manufacturing new drugs. Natural health products (NHPs) are no exception. NHPs are defined as vitamins and minerals, herbal remedies, homeopathic medicines, probiotics, and other products like amino acids. Since NHPs don’t require a prescription for sale, they must be safe to use as over-the-counter remedies. This is where good manufacturing practices come into play. From quality and risk management to ongoing post-marketing activity, Good Manufacturing Practices (GMP) compliance is required at multiple stages of NHP production. This blog will explore.. READ MORE »
Regulatory affairs play a key role in ensuring the public’s safety and well-being, affecting the pharmaceutical and health industry in profound ways. Those interested in studying regulatory affairs are able to better understand regulatory systems, legislations, and practices that impact the development and quality of pharmaceutical goods. Here, students have the opportunity to explore regulatory labelling—which is essential across a wide range of industries, especially in the pharmaceutical world. With this background, students can better understand (and consequently meet) the labelling and product summaries requirements after completing the program. Equipped with this knowledge, students can become professionals who are ready.. READ MORE »
Pharmaceutical professionals have extensive knowledge to analyze the raw materials, processes, and finished products to determine the safety and efficacy of a new drug. Pharmaceutical quality assurance is a crucial practice in the manufacturing practice. This is where pharmacopeias come into play. Pharmacopeias are documents designed to provide public standards relating to the quality, safety, and efficacy of a drug. Today, pharmacopeias play a major role in the regulatory process and control of pharmaceutical ingredients. Analysts for pharmaceutical quality assurance will draw upon these standards in their methods of quality control. With the global expansion of drug manufacturing and standards,.. READ MORE »
All kinds of medications are used to help relieve pain, prevent illnesses, manage diseases to avoid further complications, and much more. These medications typically fall into two categories: prescription (Rx) drugs and over-the-counter (OTC) drugs. There are many important differences between these two broad categories, which are important to regulatory affairs. Continue reading to explore the differences between both categories while gaining a brief look into some of Canada’s regulatory measures regarding Rx and OTC drugs. A Basic Overview of Over-the-Counter Drugs As you get ready to take online pharmaceutical courses, what are some important things to know about OTC.. READ MORE »
With the inter-connectedness of the internet, professionals can now choose to up-skill and re-skill from the comfort of their homes. It’s possible to become educated in complex, interesting pharmaceutical subjects without needing to physically attend a class. This carries many benefits, including: Saving time on travel to and from school Attending class from a comfortable environment Constant access to course materials Flexibility of location However, online courses may present difficulties in terms of self-direction. Because it is ultimately up to the student whether they study, attend online lectures, and remain focused on the subject, it may be easier for some.. READ MORE »
Karl Fischer was a German chemist who discovered that the Bunsen Reaction between iodine and sulfur dioxide could be modified to help determine water content in a non-aqueous system. In 1935, he published this new method, which came to be known as Karl Fischer titration. To learn more, let’s take a look at a few interesting facts about this very important titration method! 1. It Has Several Applications Crossing Many Industries As a student of pharmaceutical quality assurance, you will soon learn about the Karl Fischer Titration method. This method is one of the most accurate procedures for determining the.. READ MORE »
When a manufacturer stamps a medication bottle with an expiration date, this date reflects the period of time the drug is known by the manufacturer to be stable. The stability refers to the length of time the drug should retain its quality, potency, and purity when stored in recommended conditions and in its original packaging. To understand more about how Health Canada works with drug manufacturers to regulate the expiration dates of medications in Canada, and shed some light on some new thinking on the accuracy of these dates, let’s examine the issue more closely. Drug Expiration as Governed Under.. READ MORE »
A professional working in regulatory affairs has the task of ensuring that all kinds of products from cosmetics to pharmaceuticals to human and veterinary medicines meet legislative requirements. When it comes to vaccines, this process means reviewing emerging vaccines for safety, efficacy, and quality. The development of vaccines under normal circumstances requires trials involving thousands of people, and can take many years to approve under a stringent review process. In the face of COVID-19, many vaccines are currently being developed at a much quicker rate, presenting complicated challenges for both the manufacturers of these new products as well as the.. READ MORE »
