In an ever changing and complex industry the role of the Responsible Person has developed and grown over the past 10 years as the focus of regulatory bodies have placed a higher level of scrutiny on how GDP principals are implemented and applied for Wholesale Distributors.
Initially the main areas of compliance for companies who distribute products through a wholesale licence were quite straight forward:
- Medicines in the supply chain are authorised in accordance with European Union (EU) legislation.
- Medicines are always stored in the right conditions, including during transportation.
- Contamination by or of other products is avoided.
- Adequate turnover of stored medicines takes place
Over the past decade with the change in business models that can include complex supply chains and products. The role of the RP has been expanded on numerous fronts. These include:
- Complex supply chains.
- Bona fide qualifications.
- Introduction of the Falsified Medicines Directive and Serialisation.
- Risk Management as per ICH Q9.
- Virtual Business
The main change is ensuring the product supply chains are assessed, reviewed, and qualified to ensure compliance with GDP and the specifications of the product. To complete this the RP needs to be aware of each step of the supply chain. Bona Fide checks are completed for all relevant parties which includes suppliers and customers. Also to be aware of changes to the supply chain and compliance checks of suppliers and customers.
The introduction of the Falsified Medicine Directive has been one of the biggest hurdles for RPs (Responsible persons). This involved completely re-examining their Quality Management systems to adapt to the requirements of serialisation and introduction of new software and hardware to allow for the physical processing of a product.
Since the introduction of ICH Q9 by the ICH, risk management has been a hot topic for GDP regulatory inspectors. How the company manages risk, implements risk strategies and risk mitigation factors through all the procedures and forms in their Quality management system and the supply chain are one of the first ports of call for inspectors.
One of the biggest challenges is the change over from the traditional wholesale model which involved a warehouse and office to the now more preferred approach of a virtual wholesale operation. This change has put more emphasis on the RP (Responsible person) to ensure that all sub-contractors used by the company are at the correct standard of GDP as the responsibility of the sub-contractors is with the RP.
Going forward the RP of the future will need to be well versed in many areas of the pharmaceutical industry to ensure they keep ahead of the changes in regulations and guidelines as you have to think local as well as global when implementing any changes to your system.
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