The Responsible Person: What are the Key Elements which should be covered a Job Description?

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According to Chapter 2, article 2.2 of the EU-GDP Guidelines ("Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)"), "the wholesale distributor must designate a person as responsible person."  It further states: "The written job description of the responsible person should define their authority to take decisions with regard to their responsibilities. The wholesale distributor should give the responsible person the defined authority, resources and responsibility needed to fulfil their duties."

Elements which should be covered a job description

Chapter 2, article 2.2 of the EU-GDP Guidelines defines the requirements, responsibilities and duties of the RPs. The RP’s job description should list the responsibilities detailed in the GDP Guidance, plus any other company specific activities assigned to him/her. Thus, the following objectives and responsibilities should be part of the job description:

• The RP should ensure that a QMS is implemented and maintained.
• He/she should focus on the management of authorised activities and the accuracy and quality of records.
• The RP should ensure that initial and continuous training programmes are implemented and maintained.
• He/she should be responsible for coordinating and promptly performing any recall operations for medicinal products.
• The RP should ensure that relevant customer complaints are dealt with effectively.
• The RP should ensure that suppliers and customers are approved.
• The RP should approve any subcontracted activities which may impact GDP.
• The RP should ensure that self-inspections are performed at appropriate, regular intervals following a prearranged programme and necessary corrective measures are put in place;
• He/she should keep appropriate records of any delegated duties.
• The RP should decide on the final disposition of returned, rejected, recalled or falsified products.
• He/she should approve any returns to stock.
• The RP should ensure that any additional requirements imposed on certain products by national law are adhered to.

A copy of the company’s organisation chart should be added to the job description to show where the role fits within the management structure of the wholesale distributor.

Review of the job description

The job description should be reviewed and updated whenever the nature of the business, the site authorisation and/or the regulatory
requirements change.

Example of a job description

An example of a job description can be found in the Code of Practice for Code of Practice for Responsible Persons (RPs) which has been published by the European GDP Association. You can download the document in the members area. If you are not a member yet, you can apply for free membership.