GMP is the license for exploitation in pharmaceutical manufacturing and is a fundamental requirement worldwide. However, rules and interpretations differ from country to country and change frequently. Therefore, it is very important to have fully trained experts to help implement these regulations. The FDA inspects pharmaceutical manufacturing facilities around the world, including facilities that manufacture active ingredients and the finished product. Inspections follow a standard approach and are performed by highly qualified FDA personnel. The FDA also relies on reports of potentially defective drugs from the public and industry. The FDA will often use these reports to identify sites that require inspection or investigation. Most of the companies inspected are fully compliant with CGMP regulations. The GMP version of the World Health Organization (WHO) is used by pharmaceutical regulators and the pharmaceutical industry in more than 100 countries around the world, mainly in developing countries. [3] The European Union`s GMP (EU-GMP) applies similar requirements to the WHO GMP, as well as the US version of the FDA. Similar GMPs are used in other countries, with Australia, Canada, Japan, Saudi Arabia, Singapore, Philippines], Vietnam and other highly developed/demanding GMP requirements. [17] In the United Kingdom, the Medicines Act (1968) covers most aspects of GMP in what is commonly referred to as “The Orange Guide”, so called because of the colour of its envelope; it is officially known as rules and guidelines for manufacturers and distributors of pharmaceutical products. [18] If a company does not comply with the CGMP regulations, any drug it manufactures is considered “falsified” by law.

This type of adulteration means that the drug was not manufactured under GMP equivalent conditions. This does not mean that there is necessarily something wrong with the drug. The last cGMP was published in 2016, the Q7 Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients. This 58-page document included excellent previous GMP updates for the industry, but also raised more questions than it answered in the eyes of many pharmaceutical companies. The FDA followed up in 2018 with a question-and-answer session to clarify some of the most common questions about the latest guidelines. Some of these questions are answered here with insights from experts in the pharmaceutical industry. Good Manufacturing Practices (GMP) are the practices required to comply with guidelines recommended by authorities that control the approval and licensing of the manufacture and sale of food and beverages[1], cosmetics[2], pharmaceuticals[3], food supplements[4] and medical devices. [5] These guidelines set out minimum requirements that a manufacturer must meet to ensure that their products are of consistently high quality from batch to batch for their intended use. The rules that apply to each industry can vary considerably; However, the main goal of GMP is still to prevent damage to the end user.

[2] Other principles include ensuring that the final product is free of contaminants, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been tested for quality more than in the final phase. [2] GMP is generally ensured through the effective use of a quality management system (QMS). [1]: “The basis of GMP”, [2] It is important to note that the minimum GMP requirements are. Many pharmaceutical manufacturers already implement comprehensive and modern quality systems and risk management approaches that go beyond these minimum standards. Regular inspections should be conducted to verify that GMP is being implemented and complied with. Document areas that require more work and propose corrective actions for continuous improvement. Quality audits are carried out to evaluate the quality systems implemented by the manufacturing company. GMP audit checklists can help companies comply with GMP guidelines established by regulatory authorities. By performing visual step-by-step procedures on site and performing manufacturing assessments, you can identify non-compliant processes and take immediate action to resolve issues that need improvement.

In the United States, for example, GMPs are enforced by the U.S. FDA through current Good Manufacturing Practices (GMPCs), which cover a wider range of industries such as cosmetics, food, medical devices, and prescription drugs. The FDA conducts factory inspections to assess whether a manufacturing company is complying with CGMP regulations. If serious violations are detected during the inspection, the FDA recalls all products, which is problematic for manufacturers in terms of profits and business operations. When GMP is tracked, companies can avoid many of the most common causes of quality failure that compromise patient safety, such as. B contamination of medicinal products, discrepancies or confusions. The FDA recognizes that cGMP is designed for flexibility to create a universal framework for the entire pharmaceutical industry. In addition, the guidelines are not a checklist. This is a set of “minimum requirements” for total quality management. Discover expert perspectives on the overlapping worlds of pharmaceuticals and engineering. From the FDA`s perspective, very few drugs pose no risk to patient safety. Risks can take many forms, including: The FDA currently offers 34 different definitive guides for GMP in the pharmaceutical industry that include requirements for process validation, data integrity, quality measurements, and countless other topics.

If you`ve been in the pharmaceutical industry for a decade or more, you`ll realize that “design on inspection” is a relatively new principle within cGMP. .