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WHO GMP Audit in Thane
25,000 - 30,000 Per piece
GMP Certification Services A good manufacturing practice (gmp) is a production and testing practice that helps to ensure a quality product. many countries have legislated that pharmaceutical and medical device companies must follow gmp procedures, and have created their own gmp guidelines that correspond with their legislation. basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. in the u.s. a drug may be deemed adulterated if it has passed all of the specifications tests but is found to be manufactured in a condition which violates current good manufacturing guideline. therefore, complying with gmp is a mandatory aspect in pharmaceutical manufacturing. Applicable:- pharmaceutical medical equipment food industries The guiding principle of GMP is that quality is built into a product, and not just tested into a finished product. therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made. there are many ways this is controlled - controlling the quality of the facility and its systems, controlling the quality of the starting materials, controlling the quality of production at all stages, controlling the quality of the testing of the product, controlling the identity of materials by adequate labeling and segregation, controlling the quality of materials and product by adequate storage, etc. all of these controls must follow prescribed, formal, approved procedures, written as protocols, sops, or master formulae, describing all the tasks carried out in an entire manufacturing and control process. a 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. 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. good manufacturing practices (gmp) are production and testing practices that helps to ensure a quality product. many countries have legislated that pharmaceutical and medical device companies must follow gmp procedures, and have created their own gmp guidelines that correspond with their legislation. gmp guidelines are not prescriptive instructions on how to manufacture products. they are a series of general principles that must be observed during manufacturing. when a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill gmp requirements. it is the company's responsibility to determine the most effective and efficient quality process.
