Quality assurance definition in pharmacy

It can be a challenge to maintain a company-wide dedication to quality assurance for therapeutics and pharmaceuticals. When you have a product that has the potential to drastically change lives, it’s hard not to do everything you can to get it to market quickly, and it can feel as though the quality assurance (QA) team is slowing down the process. However, it’s important that everyone in your company understands how crucial QA is for the success of your product and the safety of your customers. The pharmaceutical industry learned this hard lesson during the thalidomide disaster of the late 1950s. Thalidomide was given to pregnant mothers in the first trimester to help with morning sickness, a nd, as a result , 123,000 babies died in the womb, and over 24,000 children around the world were born with thalidomide-related disabilities. The US was spared from the worst of the disaster because FDA inspector Frances Kelsey was not satisfied that the drug was safe. She refused to approve it for use in the US and persisted in requesting additional clinical trial data and information. Thousands were devastated by thalidomide. Drug companies learned how important quality in manufacturing is, and Kelsey’s persistence laid the groundwork for more rigorous drug approval regulations worldwide. You can do your part to avoid poor outcomes by having a good understanding of the scope of . Ensure that your team understands your QA unit’s responsibilities and expectations and that they work we...

When In 2010, Johnson and Johnson found itself battling a firestorm after the FDA recommended a Class 2 recall of millions of bottles of OTC infant's pain relievers due to manufacturing quality problems. The headaches didn't end in 2010. Five years later, the company was still battling the FDA over how the recall was conducted. Six years later, lawyers were still offering Understanding the objectives of quality assurance and its benefits can help your company to put appropriate emphasis on and allocate sufficient resources to this crucial component of your business. 5 Objectives of Quality Assurance in the Pharmaceutical Industry Do you want to know the foundational principle that separates every industry-leading pharmaceutical company from the rest? It's that quality is an investment which leads to competitive advantage rather than an expense which is required to maintain regulatory compliance. Look at how Medtronic, one of the leading life sciences companies in the world, approaches quality: "We manufacture safe, high-quality products not only to further our Mission, but also to build trust, reduce reputational risk, and improve operational efficiency." So, certainly, there are other benefits to quality assurance in the pharmaceutical beyond just staying on the good side of regulatory bodies. Here are five of the most prominent. 1. Protect the Public Your number one goal is — and always should be — to protect the public. You are creating medications that can literally ch...

If you were to come to my office, you would find a binder I still keep on my shelf with materials from a Pharmacy Quality Alliance meeting that I attended more than a decade ago. Little did I know when I attended that meeting what impact it would have on my career. During this 2008 meeting, the conversation centered on how we define quality in health care around appropriate medication use. One of the notes I took during this meeting was “Quality is value divided by cost.” Mathematically it looks something like this: quality = value/cost. This little equation captured my imagination. As an amateur math nerd, I could see how quality could be improved by increasing value and/or decreasing costs. Immediately, strategies that we had used in the pharmacy took a whole new meaning. Products and services that were considered “value adds” now factored into this quality equation. If we used these services (and at the time, the “IF” was in capital letters) we were directly impacting quality. Believe it or not, even back then the conversation was around decreasing reimbursements, and I could also see how this action could impact the quality equation. When costs go down and the value remains the same, the quality would go up. Ralph Waldo Emerson said that “a mind, once stretched by a new idea, never returns to its original dimensions.” I can tell you that I have found that quote to be so true. My mind was blown as I began to consider this new dimension of pharmacy and how quality could ...