Guest user Created: Mar 29, 2017 Last commented: Mar 29, 2017

QMS in pharmaceutical distribution company

My company intends to import its own branded drugs from India and distribute same. We are still at the regulatory stage. Current Good Distribution Practices Guideline cGDP recommends a quality management system to be implemented, and so i started the course on ISO 9001 foundation. I am trying to define the scope of the QMS that will be implemented but am still confused on the types of documentation that will be required cause what am seeing mostly from your list is for manufacturers.

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Strahinja Stojanovic Mar 29, 2017

Answer:

You are correct, the definition of the scope is one of the crucial steps in ISO 9001 implementation and the way you determine the scope will guide you through the next steps. Since you are only distributor of the pharmaceutical products and not a manufacturer, many of clauses of the standard will not be applicable to your QMS, Therefore you wont be needing as many documents as some production company.

You will be able to exclude design and development, production and many other processes and requirements so your system will be much smaller in therms of documentation. For more information, see: What clauses can be excluded in ISO 9001:2015? https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/

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Mar 29, 2017

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