cGMP regulations, enforced by the FDA, require manufacturers to ensure their products are safe, pure, and effective, and that they are produced under controlled conditions. These regulations cover all aspects of pharmaceutical production from starting materials, facility and equipment to training of personnel and sanitation and hygiene, and are continuously updated to reflect current best practices and technological advancements to prevent errors, contamination, and deviations during manufacturing, packaging, and testing.

The EU's Annex 1 regulation focuses on the manufacture of sterile products, emphasizing contamination control strategies, risk management, and the implementation of barrier technologies to minimize human intervention and prevent contamination. The updated guidelines, effective August 2023, require a comprehensive Contamination Control Strategy (CCS) that covers all aspects of manufacturing, including facility design, equipment, personnel training, and cleaning/disinfection processes. Annex 1 aims to enhance product sterility, patient safety, and regulatory compliance within the pharmaceutical industry by promoting continuous monitoring and improvement.

OSHA standards aim to ensure safe and healthful working conditions for workers by setting and enforcing standards and by providing training, outreach, education, and assistance. These standards cover a wide range of workplace hazards, including exposure to hazardous chemicals, biological agents, and physical risks. OSHA regulations also mandate the use of personal protective equipment (PPE) when necessary to protect workers from these hazards. Compliance with OSHA standards is crucial for maintaining a safe work environment and preventing workplace injuries and illnesses, especially in industries that handle hazardous materials.