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One of the few things we can all agree on is that the products offered to consumers must be of the specified quality. This general requirement becomes even more relevant when the products are pharmaceuticals, because if they are defective they could endanger the lives of consumers. To avoid this, GMP (Good Manufacturing Practices) or GMP (Good Manufacturing Practices), known internationally as GMP (Good Manufacturing Practices), emerged in the United States in the 1960s.<\/p>\n\n\n\n
In our training we reviewed all the critical aspects to be taken into account in order to be able to apply the regulations properly.<\/p>\n\n\n\n
The objective of GMP was to guide pharmaceutical laboratories by proposing an appropriate way of manufacturing to ensure the quality of the products. As this was a novelty, it was difficult both to agree on a text of “good practices” and to get the industry to follow them in general.<\/p>\n\n\n\n
The World Health Organization (WHO) supported this initiative from the outset, publishing good practice texts and encouraging their application in the pharmaceutical industry. WHO GMP\/GMP\/GMP are published as annexes in its Technical Report Series (TRS). The “good practice” texts have been updated over time and have also increased in length and complexity.<\/p>\n\n\n\n
For practical purposes, the GMP\/GMP\/GMP guide published in 1992 as Annex 1 of Report 32 (TRS 823) and consisting of three parts can be taken as a starting point:<\/p>\n\n\n\n
Part 1 – Quality management: philosophy and essential elements.<\/strong><\/p>\n\n\n\n Part 2 – Good Practices in Production and Quality Control<\/strong><\/p>\n\n\n\n Part 3 – Sterile Pharmaceuticals<\/strong><\/p>\n\n\n\n As stated above, this 1992 guide proposed a general framework for quality assurance in pharmaceutical laboratories.<\/p>\n\n\n\n Although so far in the 21st century the basic concepts described in these GMP have not changed, it has become necessary to clarify and develop some concepts. It has also been necessary to take into account the guidelines established by the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). Although the ICH does not itself modify GMP\/GMP\/GMP, it does introduce a new way of understanding them, a new “philosophy”, based on the application of scientific criteria, risk and knowledge management and the use of life cycle and supply chain approaches.<\/p>\n\n\n\n For this reason, Report 37 (Annex 4 of TRS 908) was published in 2003, in which parts 1 and 2 of Report 32 were revised. The GMP\/GMP specifically referring to sterile products were separated and have since been published as independent guidelines.<\/p>\n\n\n\n Subsequent to this date, WHO has published two further updates. In 2011 as Annex 3 to Report 45 (TRS 961) and in 2014 as Annex 2 to Report 48 (TRS 986).<\/p>\n\n\n\n With these revisions, WHO is keeping in line with the other \/GMP guidelines being published and thus ensuring that the homogeneity necessary for the pharmaceutical market to be global is maintained.<\/p>\n\n\n\n It is hoped that WHO’s collaboration with international organizations such as ICH and PIC\/S (Pharmaceutical Inspection Co-operation Scheme) will in the near future allow for a single GMP\/GMP guideline standardized on a global scale.<\/p>\n\n\n\n In our course Evolution of GMP: general forms, we will review in detail all these changes so that you can ensure that you are compliant in your work.<\/p>\n\n\n\nGMP Course: Adapting to WHO Report 37 (general forms)<\/h2>\n\n\n\n