3 Things Students in Quality Assurance Training Need to Know About the FDA’s Quality Testing StandardsMarch 27, 2018
The Food and Drug Administration (FDA) is an important US federal agency. It’s tasked with ensuring that the public health of the United States is not in any way adversely affected by food products, pharmaceuticals, prescription drugs, or cosmetics that producers wish to bring to market. As a regulator, it must apply strict quality criteria for both aspirant products and those already approved to be sold in the US market. Understanding how and why the FDA applies these standards is crucial for quality assurance professionals who work in any of the above sectors, and whose products are destined for the United States.
Grads of Quality Assurance Courses Deal With Testing Smoothly and Successfully
As it stands, the average new drug approval process under the FDA takes over 12 years. This means that the cost of bringing a new drug from initial concept to retail will often be in excess of CAD $400 million. This represents a major long-term investment for pharmaceutical and drug development companies. Only a tiny fraction of drugs make it through the entire process, with clinical testing whittling the number down over years of trials. The combination of this rigorous approval process, in addition to the rigorous work of quality assurance professionals, helps to ensure that only the safest products make it to consumers.
Professionals with Quality Assurance Training Know Testing Continues After Approval
Once a pharmaceutical product has been approved by the FDA, the quality assurance process does not rest. The agency is committed to ensuring the effectiveness of the drug—making sure that the product consistently delivers in its specific use, and does not emerge as a hazard to consumers. Quality control inspections are described as partially “event-driven” by the FDA, with certain products being put in line for quality testing should anything such as an adverse production facility event occur, or a pattern of consumer complaints regarding it emerges.
Other factors, including informed observations from qualified experts within and outside the FDA can also contribute to the triggering of a quality assurance examination. Aspects that the FDA will focus on include ingredient ranges, potency, effectiveness, and purity. Therefore, well-trained professionals with quality assurance training should seek to have QA/QC principals firmly established within the company in order to stand up to official scrutiny at any point in time.
QA Process for Drugs and Pharmaceuticals Utilizes High Standards
The FDA utilizes the guidelines and standards published by the US Pharmacopeia (USP) in order to assess the quality of drugs and pharmaceutical products under its purview. The monograph standards set by the USP provide a framework for quality, helping to ensure the right drug is contained in the packaging, how much of it is present, and if there are any production issues such as impurities present.
The FDA has a fall-back solution for any products that are not compatible with these USP standards, instead referring back to the initial framework that was set up during the product’s approval process. In this respect, company-employed graduates of quality assurance courses can observe these initially established standards, as they will be relied upon throughout the life cycle of any developed product.
Do you want to build a rewarding career ensuring the efficiency of much-needed medicines?
Contact AAPS today to learn the value of a quality assurance certificate in Canada’s expansive pharmaceutical industry.