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What are the regulations governing pharmaceutical production?

Pharmaceutical manufacturing is a highly regulated industry, where compliance with strict standards and norms is essential to ensure product safety, efficacy and quality. These standards are established by various international and local authorities and organizations, and cover every aspect of production, from the design of plants and manufacturing processes to the final distribution of products. The main regulations governing pharmaceutical production include:

 

• Good Manufacturing Practices (GMP): Good Manufacturing Practices are the cornerstone of pharmaceutical production regulation. GMP is a set of guidelines describing the procedures, processes and conditions necessary to ensure that pharmaceutical products are manufactured and controlled consistently according to appropriate quality standards. The GMP covers a variety of aspects, including staff training, cleaning of facilities, quality control, documentation, equipment maintenance and risk management. GMP standards are adopted internationally, with specific versions in different countries, such as the European Union, the United States (regulated by the FDA), Japan and other jurisdictions; 
• Good Laboratory Practices (GLP) are another set of fundamental guidelines that govern the conduct of pre-clinical trials necessary for drug development. The GLP sets out requirements for study organization, personnel management, equipment maintenance, data collection and analysis, and documentation of results. Compliance with GLP is crucial to ensure that pre-clinical data are reliable and reproducible, and can be used to support new drug marketing applications; 
• European Medicines Agency (EMA) and Food and Drug Administration (FDA) regulations: in Europe, EMA is the regulatory body that oversees scientific evaluation, supervision and monitoring of drug safety. EMA sets out detailed guidelines that pharmaceutical companies must follow to obtain marketing authorisation for new drugs within the European Union. In the US, the FDA plays a similar role, with a series of regulations and guidelines covering the entire life cycle of pharmaceutical products, from research and development to production and marketing. Both agencies require compliance with GMP, GLP and other specific standards. 

Nemesis offers advanced pharmaceutical quality control and weighing solutions designed to meet the stringent regulatory standards required for pharmaceutical manufacturing. Nemesis checkweighers allow you to check the level of filling of the packages, ensuring that each product is within the established weight limits. These devices not only check the weight, but also help to ensure the integrity and completeness of the packaging, ensuring that no essential components are missing. Furthermore, Nemesis checkweighers are critical to ensuring product traceability, a critical aspect of the supply chain.

 

Nemesis also offers tailored solutions and combined machines that integrate checkweighers with metal detectors, allowing to detect and remove any contamination from metals. This combination ensures even more stringent quality control, maintaining the integrity and quality of products throughout the production chain. These technologies enable pharmaceutical companies to significantly improve their operational efficiency, reduce the risks associated with non-compliant products and ensure compliance with international regulations.