Gmp Registration Service

"Good manufacturing practice" or "GMP" is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines, and in some countries such as the USA regulations, that outline the aspects of production and testing that can impact the quality of a 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 principles of GMP
A. Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
A. Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
A. Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices).
A. Operators are trained to carry out and document procedures.
A. Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected.
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