Update to the EU Code of Practice for the Responsible Persons for GDP
The RP must play their role in ensuring patients receive medicines that have been distributed in accordance with predefined criteria and conditions. Once a product has been released by a Qualified Person (QP) on behalf of the manufacturer, the RP must ensure that the safety, quality and efficacy of the product is maintained within the wholesaling operation in-line with the EU Guide to Good Distribution Practice (2013/C 343/01).
The European GDP association set up a task force to support RPs in accordance with the guidance above to achieve the desired standards as well as promoting continued professional development (CPD) by developing a ‘Code of Practice The Responsible Person for GDP’. Version 2 of the Code of Practice, published in November 2018 (see link below), delivers greater detail in the recommendations provided to meet the responsibilities and duties for both permanent members of staff and contract RPs. The recommendations are applicable to RPs in both large and small organisations, which should be tailored depending on the business needs.
Information regarding important topics such as data integrity, which is an essential component of quality compliance1 and continues to be an issue in the pharmaceutical industry2, have been updated in Version 2 of the Code of Practice, as summarised below:
Responsibilities and Duties of the RP
This section is based on Chapter 2, article 2.2 of the EU GDP guidelines and provides recommendations based on each of the requirements of RPs, taking into consideration the factors which should be considered when appointing an RP, e.g. the size and complexity of the organization. The knowledge and experience that is required of an RP is also listed here, which may be beneficial when submitting information to regulatory authorities, including the approximate number of years’ experience required. Additions to this section include the requirement to understand current data integrity expectations, auditing requirements and auditing techniques, being familiar with the specific GDP operations of the licence holder and understanding the typical IT systems used in GDP activities.
Details of the information which should be incorporated into a job description for an RP is also provided in this section, along with a template, to assist employers and individuals to establish the role of the RP within an organisation and define their authority to take decisions. It is suggested that the number and type of licences associated with the company is now included in the RP job description. A useful matrix of ‘Designated Responsibilities’ defines the responsibilities of the RP which are juxtaposed with senior management and regulatory authority responsibilities.
The careful selection of the RP by the wholesale distributor and provision of adequate resources to ensure continued compliance with GDP guidance is discussed.
Recommendations of how the RP can fulfil his/her specific responsibilities have also been updated including reference to monitoring of corrective actions, attending appropriate training courses, performing and reporting mock recalls and using data from customer complaints to improve services. RPs are also reminded to perform regular due diligence checks on suppliers and customers in addition to ensuring sub-contractors are legally allowed to offer the services proposed.
Finally, in this section, any references to “controlled” medicines have been updated to include homeopathic and veterinary medicines.
External RP (Contract RP)
A Contract RP is expected to have the same level of experience, training, responsibility and authority as a permeant RP in the organisation and this is referred to throughout the code of practice.
To ensure this occurs, a technical agreement is required detailing the full name of the RP in addition to their required availability and expectations. The specific requirements of a contract RP and the licence holder with regard to the RP, is outlined in this section of the document.
Organisational Duties to be Established by the Company Employing the RP
The duties of the employer including involvement in the implementation and maintenance of the Quality Management System (QMS), putting a clear job description in place for the RP and providing access to all relevant documents and dossiers are all re-iterated here.
Educational Background of the RP
Although the GDP guideline states that a “a degree in pharmacy is desirable”, the code of practice notes that the degree subject is not critical provided that the competent authority does not have this specific requirement. The RP, however, must still have relevant training and experience detailed in the guidance/ code of practice.
Ongoing training / Professional Development of the RP
This section refers to the ongoing training requirements of an RP identifying the recommended number of training days which should be planned per year and the topics to be covered.
This guidance document is based on industry good practices and aims to provide a benchmark to assess skills, knowledge and experience of RPs across the sector. Version 2 of the Code of Practice for Responsible Persons can be found in the members area of the GDP Association website at the link below:
If you wish to discuss how PharmaLex can support your GDP requirements including the provision of a contract RP or the development of related activities, please connect with us at +353 1 846 4742 or email@example.com.
- PharmaLex Ireland. Understanding the Impact of Culture and Behaviours on Data Integrity Compliance. 28th November 2018. https://www.pharmalex.com/data-integrity-compliance/
- ECA Academy. Frequent GMP Deficiencies at API Manufacturers reflected in Warning Letters – Current Trends. https://www.gmp-compliance.org/gmp-news/frequent-gmp-deficiencies-at-api-manufacturers-reflected-in-warning-letters-current-trends