Pharmaceutical training in Computer System Validation (CSV) is essential for maintaining compliance with health authorities like Health Canada, the FDA, and the European Union. CSV ensures that computerized systems in healthcare, including pharma and medical devices, are validated for their intended use. This blog introduces CSV’s importance in pharma, the regulatory landscape, and key components. It also highlights a related workshop by AAPS to help professionals gain foundational knowledge. What Is Computer System Validation (CSV)? Pharmaceutical training teaches that Computer System Validation (CSV) ensures a computer system consistently performs as intended, complying with regulatory requirements. This process is vital in.. READ MORE »
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 »
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 »
When attaining an education in pharmaceutical quality training, you’ll become well-versed in the principles of quality control and quality assurance. These are principles that guide the pharmaceuticals industry in ensuring that all products are developed, manufactured, and sold in a safe and effective manner. Whether you work in a laboratory or reviewing documents, you’ll be part of a necessary system of making sure the drugs consumers use do not cause them harm. Good Manufacturing Practices, or GMP, is one part of quality assurance. Governing pharmaceutical as well as radiopharmaceutical, biological, and veterinary drugs, GMPs ensure that these substances are consistently.. 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 »
Ontario is often referred to as Canada’s economic powerhouse, and that’s certainly the case when it comes to its pharmaceutical presence. Numerous major producers and research companies—who represent major employers for local graduates—call Ontario home. In fact, whether you want to work at a small home-grown company or at the regional office of a major international player, there’s a good chance that your dream company could be located not too far away. Are you interested in establishing a career in Ontario’s pharmaceutical sector? Here’s a quick snapshot of Ontario’s pharmaceutical industry, and what new graduates can expect. Why Ontario Has.. READ MORE »
Among the many tricky problems faced by the pharmaceutical industry, the fact that each patient is unique creates a particularly difficult one to solve. For medication to be affordable, it often needs to be mass-produced, which means a “one size fits all” approach is taken, rather than the creation of medication made for maximum effectiveness for each individual. With qualities like size, age, gender, and many other factors contributing to the ways in which a drug might react with the body, this approach complicates dosing, leads to uncertainty about side effects, and presents a number of other difficulties for patients.. READ MORE »
Professionals working in pharmaceutical quality control play an important role testing and regulating drugs as they are manufactured for market. There are many different types of drugs and medications that come in a wide variety of forms. From tablets, liquids, and gels, to vials for injections and transdermal patches, each method of delivery has its own testing needs and standards. If you’re considering a career in pharmaceutical quality control, here’s a quick introduction to transdermal patches. Pros with Pharmaceutical Quality Control Careers Know How Transdermal Patches Work Transdermal patches are a vehicle for delivering medication through an adhesive patch placed.. READ MORE »
The process of developing modern medicines has been one of exploration, with numerous kinds of delivery mechanisms used for different forms of treatment. Today, people take medication that comes in a variety of forms—everything from injections into the bloodstream, to dermal patches, to capsules filled with powdered medication, and beyond. One less common delivery system that is nonetheless hugely important is aerosol delivery. An aerosol is a collection of solid or liquid particles mixed in with gas, and using this format to deliver medication can have a few advantages over other kinds. Here is a look at the two main.. READ MORE »
Many pharmaceutical companies will develop, test, trial, and manufacture their own drugs and products. However, performing all of these duties is extremely time consuming and requires a lot of resources. Researchers, laboratory equipment, manufacturing equipment, and quality assurance personnel all come at a premium. Because of these costs, many pharmaceutical and biopharm companies are now outsourcing their manufacturing processes. Companies that provide this outsourcing service are called contract manufacturing organizations. As a future quality control and assurance professional, here’s what you need to know about contract manufacturing organizations. Contract Manufacturing Organizations Are Hired to Fulfill Many Duties Contract manufacturing organizations.. READ MORE »
