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Pharmaceutical Certifications

Taking Pharma Courses? Discover the Importance of Cleaning Validation

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 »

Studying Regulatory Affairs? The Importance of GMPs for Natural Health Products

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 »

Earning an HPLC Certification? Here’s an Overview of Technological Transfer Protocols

A technology transfer is a common occurrence in the pharmaceutical industry. It happens when a company wants to switch their operations from an existing manufacturing site to a new manufacturing facility. In that event, the manufacturing process and analytical methods must also be transferred between units, for the sake of consistency.  Technology transfer between units is an essential process of the pharmaceutical industry when a new drug moves from the pilot batch to a large-scale commercial batch. These protocols are needed to promote successful progress between manufacturing stages: from drug discovery to product development to clinical trials to commercialization. For.. READ MORE »

How Drug Expiry Dates are Created, Explained for Students in Drug Safety Courses

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 »

Understanding Drug Bioavailability in Drug Safety Courses

Bioavailability is an important concept for those invested in drug safety and pharmacovigilance to be aware of. Verifying and regulating rates of bioavailability of a drug can ensure that clinically significant doses are being delivered to patients, or that toxic doses aren’t being accidentally delivered. For a drug with low bioavailability, a larger dose would be required to breach the threshold of minimum effective concentration.  Bioavailability is, in essence, the rate and fraction at which a drug reaches systemic circulation unaltered. Certain drugs, such as those administered topically, do not require systemic circulation. For these, bioavailability will be irrelevant. However,.. READ MORE »

Understanding Cannabis Pest Control and Prevention for Those in Cannabis Quality Assurance Courses

Like many other types of plants, cannabis crops can be vulnerable to destruction by insects when it comes time to harvest them. There are also many ways in which these pests can interfere with crops that are grown indoors and outdoors. Anyone hoping to find a career in cannabis quality assurance should understand how pests can derail the healthy growth of these plants, and how to prevent further damage. Since these types of insects can multiply rapidly, it is necessary to prevent pests and mitigate potential risks to plants in greenhouses or outdoors to maintain healthy crops, and the ability.. READ MORE »

In Quality Control Courses? Learn the Role of Dissolution in the Development of Pharmaceuticals

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 »

Know These Food Allergies and Intolerances if You’re Interested in Getting a Food Handling Certificate

In 2019, Food Allergy Canada launched the National Food Allergy Action Plan. This initiative is aimed at guiding policies that will improve quality of life for Canadians with food allergies. The current available estimate is that 1 in 13 Canadians self-report having an allergy, which amounts to approximately 2.5 million people who would benefit from such policies. How are these allergies dealt with in Canada? Canada has what are called “priority food allergens”. These refer to the list of foods associated with 90 percent of allergic reactions and there are labelling requirements for them. While many allergies may be familiar.. READ MORE »

What to Know About Package Inserts if You’re Considering a Regulatory Affairs Program

Package inserts give valuable information to patients regarding their medication. Usually, this includes prescribing information, also called professional information. Prescribing information includes: Brand and name of drug Potency and/or ingredients Standard of manufacture and manufacturer or sponsor Function of the drug Precautions or warnings Dosage and instructions for administering the drug Storage information Date prepared and preparations available Package inserts also help health care professionals, as they include things like special instructions for drugs that require specific dispensing like injection. In many cases, a separate document specifically for consumer or patient information is included, either separate from or as part.. READ MORE »

A History of How HPLC Became Common in Pharmaceutical Testing

High Performance Liquid Chromatography is used in many industries including in the pharmaceutical, food, cosmetic, and the environmental sectors. The history of HPLC begins with the invention of chromatography itself, just after the turn of the 20th century. It has since evolved to become the liquid chromatography we know and use today. If you’re hoping to work with testing in the pharmaceutical industry, you may be interested to know the history of how HPLC came to be. Interestingly, many of the developments along HPLC’s journey came from industry professionals and not from university researchers or professors. Read on to learn.. READ MORE »