Navigating Regulatory Bodies in Life Sciences: The Importance of Compliance and Audit Readiness
Regulatory bodies, also known as regulatory agencies, are independent governmental bodies established to set standards for an industry and enforce those standards per legislative acts. In Life Sciences, these regulatory bodies oversee the process of production of new products such as drugs, biologics and medical devices, including regulating the research and testing process as well as the quality of the final product. These processes are divided into three main categories: GCPs (Good Clinical Practices), GLPs (Good Laboratory Practices), and GMPs (Good Manufacturing Practices).
There are multiple regulatory bodies across the globe, and it is important for organizations to familiarize themselves with the regulations of the regulatory bodies that govern their target market. For example, in the USA, the Food and Drug Administration (FDA) oversees regulatory compliance, while in the EU, the European Medicines Agency (EMA) is responsible for regulatory compliance. Other examples include Health Canada in Canada and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
Audits conducted are inevitable for all life sciences organizations. Failure to demonstrate regulatory compliance based on their target market can have major financial and organizational consequences. Given the importance of regulatory compliance, every life sciences organization should have a Regulatory Affairs department or its equivalent to always be audit ready and to:
Stay up to date with legislation concerning drug research, manufacturing, and marketing
Ensure effective internal communication to prepare/train staff and have an audit strategy ready
Ensure effective external communications with regulatory agencies to demonstrate organizational regulatory compliance Regulatory bodies strive to establish fair trade, protect the rights of humans involved in the process, and ensure the safety of consumers. Compliance with regulatory bodies and their regulations should be at the center of organizational goals in Life Sciences
In summary, regulatory compliance is essential for life sciences organizations to ensure safety, maintain fair trade, and avoid financial and organizational consequences. Regulatory bodies are responsible for enforcing these standards, and it is important for organizations to stay up-to-date with their regulations and ensure effective communication to demonstrate compliance. Reach out to Precision Life Sciences of Precision Talent Group.