Good Manufacturing Practice (GMP) standards represent a set of concepts that identify essential aspects in the production of a drug and describe the good practice to be adopted to ensure that pharmaceutical products meet appropriate quality standards. Therefore, they represent the minimum standards a pharmaceutical company must adhere to in its production processes.
The code of regulations issued by the Executive and Federal Agencies of the United States of America, published in the Federal Register, has 50 titles, each addressing a differently regulated area. Precisely, 'Title 21' consists of the:
- Part 210: cGMP refers to drug manufacturing, processing, packaging, and storage activities.
- Part 211: cGMP refers to finished pharmaceutical products.
Good Manufacturing Practice has been implemented through European Directives 2001/83/EC and 2001/94/EC.
The application of GMP Guidelines is not voluntary but mandatory by law. The person responsible for production at a GMP site is the "Qualified Person" (QP and must ensure that the drugs
- are of high and consistent quality
- are appropriate for the intended use
- meet the requirements of the marketing authorisation or clinical trial.
In addition, GMP deals with risk management. The use of medicinal products involves a certain degree of risk, and the risk related to the quality of the product itself is only one component of the overall risk. A practical approach to risk management ensures high product quality by providing a proactive means of identifying and controlling potential quality issues that arise during drug development and production. In addition, applying Risk Assessment principles allows for better management of quality issues, facilitating more effective and informed decisions.
Competent authorities confirm GMP compliance. The European Medicines Agency (EMA) does this at the European level.
Good Manufacturing Practices (GMP) training provides the necessary know-how to ensure products are consistently developed and controlled according to quality standards.
The different courses within this category will help you minimise the risks of any pharmaceutical production, from quality management, procurement management, risk management and the time, cost and resources involved.