Compliance in Pharmaceuticals

The Pharmaceutical industry is one of the most heavily regulated industries in the world. Every country has some number of rules or regulations with regards to drugs and pharmaceuticals and although they are often similar, they are not necessarily the same.

This means that there are many laws and regulatory bodies that any global pharmaceutical company must track and understand. This usually requires that strict controls and processes be in place to make sure that the company is following the regulations correctly, from initial development of the drug to creating and labelling the packaging to transporting and delivering to the customer.

In the United States of America, for example, the Pharmaceutical industry is regulated by the FDA, the United States Food and Drug Administration, and the FDAs Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.

In the period between 1st Oct 2019 and 30th Sept 2020 there were 2788 483s issued. This means in that single year there were 2788 potential violations of regulations within the United States alone.

Add to that the complications of complying with the European counterpart, the European Medicines Agency, and many equivalents across the planet, such as the National Medical Products Administration (NMPA) of China or the Therapeutic Goods Administration of Australia and as you can imagine tracking and verifying that valid processes are being run correctly to ensure all regulations are followed is a monumental task.

That is why we at Maly IT Solutions have created Okuda. We saw how monumental the task is and decided to create a software tool that allows a user to build out their processes within it and to use the meta data we then track to observe and manage those processes or even perform an audit on them.

This not only has the benefit of visibility over the processes being run, it also shows where a process may be lacking or highlight areas, or steps of a process, that could be simplified or cut completely.

If this sounds like a solution to your compliance problems you can find more information or contact us at maly.co.uk

References:
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations

https://www.ema.europa.eu/en
https://www.nmpa.gov.cn/
https://www.tga.gov.au/
https://www.fda.gov/

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