Which department is responsible for testing biopharmaceutical products for safety and potency?

The department responsible for testing biopharmaceutical products for safety and potency is Quality Control (QC). This division plays a crucial role in the biopharmaceutical industry by ensuring that products meet the required safety, efficacy, and quality standards before they are released for public use. QC is involved in conducting various tests and analyses throughout the production process and after the manufacturing is complete.

In the context of biopharmaceuticals, the potency of a product refers to its strength and efficacy, while safety refers to the absence of harmful side effects or contaminants. QC personnel utilize a range of analytical techniques, including chromatography, spectrophotometry, and microbiological testing, to assess the quality of the products.

Research and Development focuses on the creation and optimization of new drugs and therapies, and while they may identify methods of ensuring potency and safety, they are not primarily responsible for the formal testing process. Production is concerned with the manufacturing processes and ensuring that products are made at scale while adhering to established protocols. Regulatory Affairs oversees compliance with regulations and submission of documentation to health authorities, but they do not conduct the testing themselves. Therefore, Quality Control is uniquely positioned within the biopharmaceutical sector to handle the critical responsibility of product testing.