International Standards of APi

Describe International standards used in Pharma Manufacturing and Packaging


8/26/20231 min read

Some of the international authorities that regulate the API manufacturing are:

The European Medicines Agency (EMA), which is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the European Union.

The United States Food and Drug Administration (FDA), which is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

The Therapeutic Goods Administration (TGA), which is part of the Australian Government Department of Health, and regulates the quality, safety and efficacy of medicines, medical devices, blood and tissues in Australia.

The Health Canada, which is the federal department responsible for helping Canadians maintain and improve their health, and regulates the safety, quality and effectiveness of drugs and health products in Canada.

The Japanese Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), which are responsible for ensuring the quality, efficacy and safety of pharmaceuticals and medical devices in Japan.

The World Health Organization (WHO), which is a specialized agency of the United Nations that is concerned with international public health, and provides guidance and standards for the quality assurance of medicines, including APIs.

These authorities have different functions and responsibilities for overseeing the API manufacturing process, such as:

Establishing and enforcing good manufacturing practice (GMP) guidelines for APIs

Conducting inspections and audits of API manufacturing facilities located in their own or other countries

Collaborating and sharing information with other authorities to improve the oversight of API manufacturing worldwide

Approving or rejecting APIs for use in their own or other countries based on their quality, safety and efficacy standards

Providing technical assistance and training to API manufacturers and regulators in developing countries

Prequalifying APIs for use in WHO procurement programmers or by other UN agency and its impact