Ensuring product quality and integrity is maintained throughout the end-to-end supply chain of medicinal products is imperative. The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities necessary to ensure confidence that the product delivered maintains its quality and integrity and remains within the legal supply chain during storage and transportation. This means that the legal owner of the product must have full oversight and traceability of the product at all times during distribution, ensuring that falsified and counterfeit medicines do not enter the product supply network. Below are three key points to consider when seeking to comply with Good Distribution Practice (GDP).
- Are GDP Self-Inspections being performed?
Performing self-inspections to ensure your company is maintaining compliance with the latest GDP requirements can be beneficial. Self-inspections can support identifying gaps and areas that are higher risk in your supply chain. An internal team assigned with the task of performing GDP self-inspections can:
- Critically review processes and procedures to check that the company is conducting supply chain activities in a GDP-compliant manner
- Review CAPAs and ensure that they are implemented and closed
- Examine records and agreements as well as procedures to ensure there are no deficiencies
Regular self-inspections can help foster a company culture of continuous improvement and compliance.
- Does your company perform Bona Fide Checks on Customers and Suppliers?
Bona fide checks, in simple terms, provide evidence that someone is who they say they are, or has the authority and experience they claim to have. Performing bona fide checks is an activity that can often be overlooked in the pharmaceutical industry but is essential for maintaining GDP compliance. Regulatory deficiencies may include:
- No bona fide checks carried out at all
- No verification that customers or suppliers are authorised to perform the operations that they are performing
- The address of the customer or supplier has not been verified, or the wrong address is provided
- Licences of the customers or suppliers not requested and reviewed. For example, a wholesaling partner who does not provide a copy of a Wholesale Distribution Authorisation (WDA) licence in the EU
Ensuring your company has a well defined procedure for performing bona fide checks and appropriately qualifying customers and suppliers can help ensure GDP compliance.
- Are company employees being effectively trained on GDP?
Personnel involved in the supply chain activities of medicinal products are required to receive training on GDP and how it pertains to the duties they perform. Deficiencies that may be observed during a regulatory audit include:
- Personnel conducting duties prior to being trained on the relevant procedures, guidelines, and legislation of GDP
- When a Responsible Person (RP) has been assigned, a role profile (job description) did not include all the required responsibilities as per Chapter 2 of the EU guidelines
- No evidence of maintaining competence through regular training/refresher training
- There was no company requirement for an assessment of the effectiveness of training to be conducted or it was not conducted adequately
Developing a training programme that is based around the guidelines and legislation will support safeguarding end users against potential hazards in the supply chain.
Contact us today for further information on ensuring GDP compliance. HiTech Health have a team of Qualified Persons (QPs) and Responsible Persons (RPs) available to support your product portfolio.
Find us on LinkedIn
EudraLex Directive 2013/C 343/01 Guidelines on Good Distribution Practice of Medicinal Products for Human Use
Health Products Regulatory Authority (HPRA) – Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances
HPRA GDP Information Day – May 2022 – http://www.hpra.ie/homepage/medicines/news-events/item?t=/gdp-and-gmp-conferences-registration-announcement&id=50581126-9782-6eee-9b55-ff00008c97d0