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Key responsibles

In big pharma, it's usually easy to separate the different responsibilities: you have a lot of people in big organization charts to show the authorities how you solve the basic requirements of EU GMP Chapter 2.

But can we come up with a minimal design? what is the smallest number of personnel that can drive a pharma company in a compliant way? Let's discover this fun fact together :)

First let's review Section 2.5 together to determine the key responsibles:

'Senior Management should appoint [...] the head of Production, the head of Quality Control, and if at least one of these persons is not responsible for the duties described in Article 51 of Directive 2001/83/EC1 , [...] one, Qualified Person(s) designated for the purpose. [...] The heads of Production and Quality Control must be independent from each other.'

So our magical number is: 2 persons can successfully drive a pharma company.

OK, but what about the second-check, double-check, review, verification, etc.? Wouldn't you need 1-1 additional person for each 'department': Production and Quality?

The answer lies in an FDA guideline on Data integrity, hidden in an Q&A (Section III/4):

'[...] in the rare instance that the same person is required to hold the system administrator role and to be responsible for the content of the records, FDA suggests having a second person review settings and content. If second-person review is not possible, the Agency recommends that the person recheck settings and his or her own work.'

So - at least theoretically - we can confirm that a 2-person company can keep up GMP.

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