Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products.
GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself. An extremely important part of GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct.
GMP is designed to help assure the quality of drug products by ensuring several key attributes, including correctness and legibility of recorded manufacturing and control documentation. Data transfers must be performed in specific ways to avoid mistakes (e.g., writing down a reading on a balance and requiring a second person to also check the balance reading to assure accuracy). Methods have been developed to make this process easier (e.g., links between equipment and central data storage facilities for direct transfer of important data). Within the European Union, GMP inspections are performed by National Regulatory Agencies and in Sweden it is issued by the Medical Products Agency Läkemedelsverket).
Additionally, GMP requires that all (manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).The European Union's GMP (EU-GMP) enforces more compliance requirements than the WHO, GMP, as does the Food and Drug Administration's version in the US.
For Natumin Pharma the certificate means that we have a permission of primary packing in blister of natural drugs as well as jar/can packaging of natural drugs.
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