Documentation has long been an important aspect of quality assurance roles across the pharmaceutical industry. While good documentation practices can be especially helpful during audits, inspections, and investigations, their utility doesn’t stop there. Documentation is a mandatory aspect of production at all levels to ensure that the products and processes of the facility remain up to standards. With quality assurance training from the Academy of Applied Pharmaceutical Sciences, you will have the opportunity to work in a state-of-the-art laboratory that simulates working in a GMP environment. By practicing what you’ll be doing in your career down the line, you can.. READ MORE »
A fundamental requirement of the pharmaceutical industry is to ensure the safety and effectiveness of products. Pharmaceutical quality assurance is a vital step in this process and helps to keep all steps and processes in line with good manufacturing practices (GMP). When documentation and data are consistently accurate, then pharmaceutical companies are able to operate and perform as expected. Within pharmaceutical quality assurance roles, this tracking of data is where statistics comes into play. Statistical methods are essential to the operations of any pharmaceutical manufacturing facility, ensuring alignment with standards of quality. Especially considering advancements in technology, coupled with new.. READ MORE »
HPLC, short for high-performance liquid chromatography, is a method of separating a mixture of compounds. HPLC offers a unique advantage, producing highly accurate identification, quantification, and purification of a certain compound or analyte. This allows professionals to perform analysis and determine specific results from the sample’s components and identify the exact substances within a mixture. During the HPLC process, in the stationary phase, a mixture in mobile phase moves through a column at a velocity determined by the nature of the particular chemical, the mobile phase composition, and the type of column. The length of time it takes the components.. READ MORE »
Hazardous material exposure can lead to adverse effects on anyone, whether an unknowing patient or seasoned healthcare professional. Around 75,000 healthcare workers are occupationally exposed to hazardous drugs, from nursing staff to laboratory research workers, causing adverse health effects. The importance of workplace safety and proper hazardous drug handling is essential for anyone looking to complete training in Pharmaceutical Quality Assurance and Quality Control. Students who pursue careers as laboratory technicians, validation chemists, and more can find themselves in direct need of hazardous material handling training, so continue reading to learn 4 basic tips for these situations. 1. Understand the.. READ MORE »
In order to ensure the safety and consistency of the pharmaceutical products we consume, there must be procedures and standards in place that regulate their quality. If you’re considering a career in Quality Assurance, Pharmaceutical Analysis, or Regulatory Affairs, a significant component of your responsibilities will be ensuring that the processes you’re adhering to align with the defined standards. When it comes to understanding how the practices around the development of pharmaceutical products are maintained, the explanation starts with Chemistry, Manufacturing and Controls, or CMC. CMC is integral to the drug development process itself, defining how manufacturers operate throughout the.. READ MORE »
Are you considering a career in the Pharmaceutical Quality Control and Quality Assurance industry? With training in this field, you’ll be qualified to work in pharmaceutical laboratories, utilizing many strategies to ensure that manufactured products and treatments are consistently safe for use. By conducting testing, overseeing manufacturing equipment and utilizing your knowledge of regulatory compliance, you can determine whether pharmaceutical products possess their intended characteristics and identity. While Quality Control (QC) and Quality Assurance (QA) practices have been around for years within pharmaceutical laboratories, technology and other advancements have altered these processes significantly. Not only have labs evolved to improve.. 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 »
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 »
Probiotics are categorized as microorganisms most typically found in dairy products, and consumed for their proven health benefits. Research has linked the consumption of the live and active culture of probiotics with the alleviation of numerous gastrointestinal troubles, and with helping to ease the symptoms of lactose intolerance. While consumers are likely to be most familiar with probiotics packaged into well-known yogurts, yogurt drinks, and cheeses, probiotics can also be manufactured into pill or tablet format for consumption as a natural health product. Before any products containing the active bacteria are released to market in Canada, however, they must receive.. 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 »
