Good Manufacturing Practice (GMP) regulations consist of a set of guidelines that ensure the consistent production of high-quality pharmaceuticals. These regulations cover all aspects of the manufacturing process, from the sourcing of raw materials to the packaging and labeling of the finished product. The purpose of GMP regulations is to:
- Ensure the safety, efficacy, and purity of pharmaceuticals.
- Minimize the risk of contamination and errors.
- Protect public health.
GMP regulations are enforced by Regulatory agencies around the world, such as the Food and Drug Administration (FDA) in the United States (US) and the European Medicines Agency (EMA) in Europe. They are based on a set of universal principles, which are:
- Quality assurance
- Risk management
- Process validation
- Continuous improvement
Pharmaceutical manufacturers worldwide must comply with GMP regulations, as non-compliance can lead to serious consequences, including product recalls, Regulatory fines, and even criminal charges. Thus, GMP regulations play a crucial role in the pharmaceutical industry, ensuring that the drugs placed on the market are safe, effective, and pure. To launch your pharmaceuticals in the market in compliance with GMP guidelines, contact Freyr's Regulatory experts now!