The new EU GDP Guideline requires that a Responsible Person for GDP has been named. In Chapter 2.2 it is defined that: "The wholesale distributor must designate a person as Responsible Person. The Responsible Person should meet the qualifications and all conditions provided for by the legislation of the Member State concerned." However there is no detailed list of qualifications in the chapter. The Guide only defines that a degree in pharmacy is desirable and that training in GDP is required.
In the UK an organisation has published a "Gold Standard for a Responsible Person". The wording "Gold Standard" might sound a bit odd because Gold Standard is understood as the best available standard. For example there have been presentations in the past when the FDA called their oversight about GMP as well as their GMP regulation and guidelines (including 21 CFR 210/211 cGMP Guide) as the "GMP Gold Standard" worldwide. The now published document provides some information about what could be part of a job description for a RP on GDP. As a consequence these tasks, skills and responsibilities should be trained to make sure that the person in charge of that function will be qualified for the job.
Most of the duties mentioned in the document are taken from the EU GDP Guideline. However, some more details have been provided. For example the RP should have knowledge in the following operations:
- carry out due diligence checks and ensure that suppliers and customers are qualified
- ensure all necessary checks are carried out and that medicinal products are authorised for sale
- manage authorised activities to ensure operations do not compromise the quality of medicines and can demonstrate compliance with GDP
- demonstrate the application of activities and provisions in accordance with the wholesale distribution authorisation and of company processes and procedures
- ensure that any additional requirements imposed on certain products by national law are adhered to e.g. specials, unlicensed imports & Controlled Drugs
Other information is provided for skills in Quality Management, Personnel, Premises and Equipment Documentation, Complaints, returns, suspected falsified medicinal products and medicinal product recalls, Outsourced Activities, Self-Inspection, Transportation and Brokers.
In a section on "Compliance" the standard refers to the MHRA licensing of medicines which the person in charge of the RP function should know. Of course this only applies to persons located in the UK. In addition the RP should know the different EU Regulations for Medicinal Products such as the EU Wholesale Directive, the Falsified Medicines Directive and other EU/EMA Guidance and Regulations. In a section on Functional and Behavioural a number of skills are mentioned such as Management and Leadership, Personal Development, Communication etc.
It should be emphasized that the "Gold Standard" is an industry guidance document only which is used by some companies in the UK. It provides only an example on what the RP should know. However, it gives some more information in order to qualify and train a RP for GDP. The ECA Academy has also seen the need for training of RPs. On a regular basis a training course is therefore offered for Responsible Persons on Good Distribution Practices (GDP)