Compliance and pharmaceuticals have a long association, although the development of each of these has been at a different pace. Pharmaceuticals and other health care products came first and whilst there was a concern with both the safety of the patient and proving the efficacy of the medicine, this was erratic, in varying from drug-to-drug and from country-to-country, and was not codified.
In the wake of some appalling incidents which resulted in the deaths of many patients, which were discussed and debated in the mid-part of the twentieth century, two pioneering acts in the USA and the UK, both in the 1960s, led to the formation of what is now known as 'Good Manufacturing Practices' (GMP).
The collective body of GMP evolved through the 1970s to the 1990s, drawing in aspects of operations management, extending out to drug distribution, and improving upon cleanroom design and operations, to name but a few.
Whilst compliance aspects of pharmaceutical drug development and manufacture have been enshrined most notably in the FDA Code of Federal Regulations and with the European Union GMPs, there has always been the dimension of 'c' GMP (current Good Manufacturing Practices), a space within which Quality assurance personnel are required to occupy in order to understand and develop new technologies and ways of working which will enhance the quality of medicinal products. .
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