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Contact SupplierAccording to the WHO, the implementation of GMP guidelines is "an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals." The WHO recommended GMP guidelines are adopted in a number of countries, while a number have harmonised their guidelines including the European Union, the Association of South-East Asian Nations and the Pharmaceutical Inspection Convention. Pharmscience is a GMP based consultancy located in Melbourne, Australia. Pharmscience provides GMP services and products to pharmaceutical and veterinary companies in Australia and Asia. The Pharmscience Newsletter is well known to many manufacturers. The issue of WHO pre qualification has been one of the major challenges of the Nigerian local drug industries and is of great concern to government because money/resources are being lost by government for non WHO pre qualification of our local drug manufacturing companies.
GMP certification is granted to manufacturing or service systems of organisations to certify that they engage with good manufacturing practices in their manufacturing or service processes, according to a Standard Code of Practice related to their business. Good manufacturing practice (GMP) is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products and medical devices.
GMP Certification confirms the products identity, composition, quality, purity and strength which they represent in the market. Under it, there is a set of guidelines that offer a system of procedures and documentation by which the confirmation of the products are given. Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups; cross contamination/mix-ups and false labelling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. A Good Manufacturing Practices (GMP) certification scheme provides independent verification and certification that the basic manufacturing practices and prerequisites necessary for the implementation of an effective Hazard Analysis Critical Control Point (HACCP) food safety programme are being followed.