GDP responsibilities:

• Approving all suppliers based in a listed country for the purpose of imports and Spain supplies.
• Approving all customers local and international.
• Ensuring all suppliers and customers based in a listed country have signed an appropriate agreement prior to any procurement taking place.
• Ensuring that all medicinal products procured from a listed country have been appropriately QP certified within a listed country and have not been outside of the listed country supply chain.
• Approving the import before being released for further distribution.
• Ensuring all medicinal products are procured from approved suppliers who hold the required authorizations to supply medicinal products to Spain.
• Ensuring import documents are checked once made available.
• Ensuring that all GDP records relating to procurement from a listed country are stored for at least five years, including archived documents.
• Ensuring that all employees have a clear understanding of the principles of risk management surrounding imports from a listed country.
• Ensuring all employees are trained and competent in their roles in relation to import from a listed country.
• Ensuring all suppliers from a listed country are clearly marked on Xero.
• Ensuring all biological products procured from a listed country have the required independent batch release certificate.
• Ensuring relevant permits are received for the import of controlled drugs ("CDs") from a listed country.
• Ensuring that all suspected falsified medicines are reported to the relevant regulatory bodies and relevant national competent authority in the source country.
• Recording and reporting any side effects of medicines imported from a listed Country to the relevant authority.
• Ensuring all products have been decommissioned in the EU Hub prior to export from the listed country.
• Ensuring that a quality management system is implemented and maintained
• Focusing on the management of authorized activities and the accuracy and quality of records.
• Ensuring that initial and continuous training programs are implemented and maintained.
• Coordinating and promptly performing any recall operations for medicinal products.
• Ensuring that relevant customer complaints are dealt with effectively.
• Approving any subcontracted activities which may impact GDP.
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
• Keeping appropriate records of any delegated duties.
• Deciding on the final disposition of returned, rejected, recalled, or falsified products.
• Approving any returns to saleable stock.
• Ensuring that any additional requirements imposed on certain products by national law are adhered to.

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General responsibilities:

• Ensuring the conditions relating to 2.6 of the Wholesale Distribution Authorisation are met and that all medicinal products from a listed country are handled, received, stored, and transported under strict GDP conditions.
• Keeping appropriate records relating to the delegation of their own responsibilities.
• Providing leadership to the regulatory team, developing and implementing operational plans.
• Regularly reviewing procedures to ensure they are all up to date with the current regulations surrounding importing from a listed country.
• Having a clear understanding of the pharmaceutical business environment in which the company operates.
• Maintaining membership in a professional body with a published code of conduct.

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Qualifications:

Acceptable qualifications are a diploma, certificate, or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in:

• pharmacy
• chemistry
• medicine
• biology or
• a related life science

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Equivalent qualifications acceptable for RPi candidates include:

• Level 5 qualifications from the Chartered Institute of Logistics and Transport.
• A Quality Management System Lead Auditor or Pharmaceutical GMP Lead Auditor qualification awarded by Chartered Quality Institute.

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The RPI must provide evidence of EEA QP batch certification and evidence that it came in from, and remained within, one of the 27 states during and after manufacture, and shipping.

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