The Food and Drug Administration (FDA)
The Medicines and Healthcare products Regulatory Agency (MHRA)
The European Medicines Agency (EMA)
Food and Drug Administration (FDA)
The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. The FDA are one of the United States federal executive departments, responsible for protecting and promoting public health. They regulate and supervise food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, bio-pharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA issue a Code of Federal Regulations which manufacturers supplying the United States must comply with. These include:
- FDA 21 CFR 210 & 211 (Pharmaceuticals)
- FDA 21 CFR Part 11 (Electronic Systems)
ZES have worked
with former FDA Inspectors to achieve inspection success.
Medicines and Healthcare products Regulatory Agency (MHRA)
The Medicines and Healthcare products Regulatory Agency (MHRA) was set up in April 2003 from a merger of the Medicines Control Agency and the Medical Devices Agency. The MHRA is the government agency, which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA is an executive agency of the Department of Health for the UK.
The MHRA regulate a wide range of materials from medicines and medical devices to blood and therapeutic products/services that are derived from tissue engineering.
- Directive 2011/62/EU (Falsified Medicines Directive)
- Directive 2001/83/EC (Medicinal products for human use)
- Directive 2003/94/EC (Good manufacturing practice for medicinal products for human use and investigational medicinal products for human use)
- EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use
The European Medicines Agency (EMA)
The European Medicines Agency (EMA) coordinates inspections to verify compliance to European Regulatory standards and plays a key role in harmonising GMP activities at European Union (EU) level. Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with EU GMP.
The Agency coordinates GMP inspections of manufacturing sites for medicines whose marketing authorisation in the EU is submitted through the centralised procedure or as part of a referral procedure.
The Agency also plays a key role in coordinating and harmonising GMP activities at an EU level. It is involved in:
- coordinating the preparation of new and revised guidance on GMP;
- ensuring common interpretation of EU GMP requirements and related technical issues;
- developing EU-wide procedures on GMP inspections and related activities;
- facilitating cooperation between Member States for inspections of manufacturers in third countries.
Three legal instruments lay down the principles and guidelines of GMP in the EU:
- Directive 2011/62/EU (Falsified Medicines Directive)
- Directive 2001/83/EC (Medicinal products for human use)
- Directive 2003/94/EC (Good manufacturing practice for medicinal products for human use and investigational medicinal products for human use)
- EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use
If you need help in achieving inspection success, ZES have EMA experience.
The World Health Organization
In response to the recent urgent need for the fast development of health products in the treatment of COVID-19, the World Health Organization (WHO) are in the process of developing a Good Manufacturing Practice (GMP) document. The GMP document will address the manufacturing of developmental batches, pilot batches and the sequential stability data. Data which is normally submitted as part of product applications (dossiers) for marketing authorization and the prequalification of medical products.
- stability
- process validation
- analytical method development and validation
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