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Regulatory and Standards
FDA regulations
The FDA, the U.S. Food and Drug Administration, is an agency within the U.S. Department of Health and Human Services. The FDA assures the safety , effectiveness, and security of human and veterinary drugs, vaccines, blood and tissue products, biotechnology, medical devices, food, cosmetics, and other products by regulating the industries involved.
The FDA primary enforces the Federal Food, Drug, and Cosmetic Act (FD&C), however it also enforces other laws and regulations according to the Public Health Service Act. In addition to FD&C, the agency enforces regulations regarding electromagnetic radiation devices, lasers, cell phones, condoms, and disease control.
Products not only may have to be approved by the FDA before use, but they may also be subject to post-market safety surveillance. This ensures that any adverse reactions to drugs are reported in a timely manner.
EU regulations
EC
EDQM – European Directorate for the Quality of Medicines and HealthCare. The EDQM harmonizes the quality standards for safe medicines throughout the European continent and other countries who are members. Harmonized quality standards are referred to as Monographs.
The EDQM evaluates and certifies active ingredients and excipients in addition to manufacturing sites.
Ph. Eur. – The EDQM Reference Standards are published in the European Pharmacopoeia (Ph. Eur)
ISO Standards
ISO, the International Standards Organization, develops and publishes international standards that companies and governments utilize for technical, industrial, and commercial applications. In addition to ISO standards, they also publish technical reports, specifications, and guides.
165 countries are members of the international body that is ISO, with over 20,000 standards set to produce services and products that are safe and have good quality, minimizing errors and waste within encompassing businesses.
ISO works in conjunction with IEC, the International Electrotechnical Commission, to develop standards relating to information technology.
Good Laboratory Practice
Good Manufacturing Practice
Good Distribution Practice
Good Storage Practice