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From Parts 1, 2 and 3 of this post we have focused on the duties of the three key personnel named in EU GMP (the Head of Production, QC and the Qualified Person).  We have also highlighted that there is no formal requirement for an Engineering Manager (or Department) AND a Quality Assurance Manager (or Department) in GMP.  Most pharmaceutical manufacturing sites do actually have these people (and departments) and we have looked at the roles and responsibilities commonly performed by these in previous posts.  There is also a final “key personnel” not named in GMP, namely the Human Resources Manager.  Bearing in mind that in the manufacture and testing of medicines it is the employees themselves who have a massive impact on product quality and the quality system then the importance of the individual who looks after employees (usually the HR Manager) cannot be understated.

In a number of GMP courses that I have presented in the past we have looked at what the delegates think the Human Resources Manager’s role should be, bearing in mind the role is not formally defined in EU GMP.  Their findings are below:

The Human Resources Manager (suggested duties from previous delegates)

  • Management of the Training system
  • Management of the Recruitment system
  • Management of the Induction process
  • Management of the Discipline procedure
  • Establishment of objectives
  • Control of the Appraisal system
  • Control and approval of Organisation Charts, Job Descriptions and Training Records
  • Payroll and expenses
  • Organisation of training courses
  • Personnel development
  • Dealing with pertinent personal issues
  • Monitoring of trends in general personnel performance

These are roles commonly performed by Human Resources departments.  They are opinions from former GMP training course delegates, and should not be seen as a specific GMP requirement.  Please let us know what you think.  Are these similar to your own HR department?  Do let us know.

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