Annual Product Review in Pharmaceuticals

We rely on medicines to address a wide range of ailments and illnesses to ensure that we live long, healthy lives. With regular advances in pharmaceuticals, we are able to address disease and improve the quality of life for a growing number of conditions.

However, while we are moving forward, it is also important to ensure that we are monitoring and tracking the performance of the products that are on the market.

To protect consumers and examine any deficiencies or areas for improvements in the products that are commercially available, an annual product review in pharmaceuticals is required. This review examines the performance of each product, evaluates the reported effectiveness of the medicine and allows for exploration into areas for improvement or re-development.

With a focus on quality control and ensuring the best interests of the public are upheld, the regulations in place ensure that the companies in engaged in the manufacturing and production of these pharmaceuticals include processes within their organization to conduct this ongoing review.

Regulatory bodies such as the Food and Drug Administration in the U.S. are responsible for monitoring the operations of manufacturers and ensuring that they are completing these reviews.

Companies are required to have a written procedure for managing their annual product review in pharmaceuticals. What’s important to note is that the regulators are not only looking at the products that make it to store shelves, but also to collect information on the batches created by these manufacturers that are rejected in production. Why is this important? For new innovations in medicine, it is important to identify the deficiencies that caused products to be rejected and illustrates the work that the company has made to address the shortcomings of the pharmaceutical and produce consistent results with a product that is ready for market. These stability studies are important to communicate the safety of the products that are going to be offered to the public.

Some of the considerations that a company should consider when implementing an annual review in pharmaceuticals looks at all elements of production and should be observed as more than an exercise in demonstrating regulatory compliance. Ongoing quality control and evaluation promotes the organization’s commitment to quality and an established protocol reduces the time cycle for development of the annual report. Approaching the product review with an eye on customer satisfaction in this process may also identify areas for increased efficiencies internally and the potential for automation. The best way to instill confidence in the company’s practices both from regulators and the public is to implement full transparency in the process of evaluation and reporting.

By exercising and documenting in-process quality controls and on-going evaluation, the annual product review in pharmaceuticals becomes a simple exercise of compiling the documents which represent the company’s due diligence throughout the year and their commitment to releasing a quality product for the benefit of the long term health and wellness of its consumers. This review is just one of many processes in place to ensure the safety and quality of medicines in which we can put our trust to meet our needs.