True or False: CGMP applies only to sterile product manufacturing.

The statement is false because Current Good Manufacturing Practices (CGMP) apply to all aspects of pharmaceutical manufacturing, not just to sterile products. CGMP ensures that products are consistently produced and controlled according to quality standards, and it encompasses a wide range of practices applicable across various types of manufacturing environments, including non-sterile formulations, devices, and biologics.

These regulations are designed to prevent contamination, mix-ups, and errors to ensure the safety, quality, and efficacy of drugs and biologics. Therefore, CGMP regulations are important for all pharmaceutical manufacturing operations, regardless of whether the products are sterile or non-sterile, large-scale or small-scale, and encompass more than just biological products. This comprehensive approach is crucial for maintaining the integrity of drug production and ultimately protects public health.