The pharmaceutical industry is constantly evolving in the field of quality assurance and control. Within that area, professionals are seeking better ways of monitoring their products, through different stages of the supply chain to consumer homes. Safety and security are top priorities. With the emergence of counterfeit markets, authenticating pharmaceutical products is more important than ever. This is where RFID technology comes in. Capable of capturing and relaying data, RFID technology has become a solution for companies looking to ensure quality, improve patient safety, and secure their reputation in the pharmaceutical industry. For students working towards a career in pharmaceutical.. READ MORE »
Pharmacovigilance (or PV) is a major part of drug safety, dealing with the detection, assessment, and monitoring of drug effects on the human body. With updated regulations and technological advancements, the pharmaceutical industry is facing pressure to automate PV systems—optimizing spending costs while also improving risk management. By doing so, PV systems would be better suited to create personalized medicine. Automation would also help promote transparent data sharing between patients and healthcare providers as well as regulatory agencies. In this way, those pursuing pharmaceutical studies can expect automation to significantly change the pharmaceutical industry. Here’s a closer look at how.. READ MORE »
Big data is a term increasingly used by professionals in the pharmaceutical industry in recent years, as it is considered to be key to furthering pharmaceutical research and development (R&D). When used effectively, the information provided helps facilitate the discovery of a new drug product. The discovery of drugs becomes an easier process, as the data is used to predict how the drug will interact with the person consuming it. This data is also used to make research more efficient and to enhance clinical trials, as well as to facilitate technological innovation and improve client safety. With the use of.. 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 »
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are one of the most common medications used by many to treat mild to moderate pain. As some of them are considered over-the-counter drugs, they’ve become increasingly relied upon by the average consumer for quick pain relief. As such, understanding how NSAIDs work and what sets them apart from other medications can be extremely valuable for students interested in pharmacology. During your pharmaceutical or regulatory affairs program, you’ll be introduced to key regulatory systems, legislations, and practices that directly affect the development and quality of pharmaceutical products. Here’s a closer look at NSAIDs for those studying.. 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 »
Good Manufacturing Practices (GMPs) are essential to pharmaceutical quality assurance. These practices are systematic procedures developed to prove consistency, safety, and efficacy. GMPs are the part of quality assurance that ensures pharmaceutical products are produced and controlled consistently, in a way that meets quality standards. Failure investigations are an important part of GMPs. These investigative procedures are activated whenever an aspect of production deviates from the quality assurance practices in place. Read on to find out three facts about failure investigations. Failure Investigations Identify the Root Causes of Deviation These investigations attempt to get to the root cause of an.. READ MORE »
Dissolution testing is a process where pharmaceutical products such as oral drugs are tested for quality control purposes, to help determine how quickly the drug is released, and aid multiple other aspects of its development. Without this form of testing, a drug’s efficacy would be much harder to gauge. Knowing how to test solid oral dosage forms and evaluate their performance is a great skill to learn for anyone pursuing a career in food and pharmaceutical research and development. But how has this process come to be? And how do oral drug products such as capsules and tablets go through.. READ MORE »
Graduates of a research and development program can work in many different areas of the pharmaceutical industry. Whether working in a testing laboratory or for a pharmaceutical company, it’s important that any research you conduct adheres to the standards laid out by the Good Clinical Practice (GCP) guidelines. GCP guidelines are set out by the International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). These international quality standards govern the designing, conducting, and reporting of clinical trials that involve human subjects. With its roots in the Declaration of Helsinki and the Belmont Report, GCP guidelines have.. READ MORE »
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 »