The European Union's GDP (Good Distribution Practice) guidelines will pass into law on 8th September 2013. Are you prepared for the changes?
Whether you are operating within the EU or planning to transport products there, understanding the changes to the GDP regulations the EU are about to make will help your organization comply, and will also help to safeguard your supply chain from fraudulent and possibly harmful products.
The 4 changes to the guidelines that may impact your business are:
- The Quality System…
- The Responsible Person…
- Outsourced Activities…
- Self-Inspections…
The guidelines are intended to maintain the quality and integrity of medicinal products as they move along the distribution chain from manufacturer to patient. They aim to help ensure wholesaler distributors use the right procedures, which prevent falsified medicines from entering the legal supply chain.
According to Louise Handy, author of Whitehall Training’s online GDP training course:
“It is really helpful to have guidance documents from the regulators. They help interpret the regulations and explain the expectations so that those providing the services can implement the practicalities in an informed way.”
1. The Quality System…
Under the new guidelines, the management is responsible for setting up and maintaining a quality system. It must clearly define all distribution activities, setting out responsibilities, processes and risk management principles. Critical steps in the distribution processes should be highlighted and any significant changes justified and validated (where relevant).
To be effective, the quality system must encompass the whole organisational structure – it’s procedures, processes and resources. It also needs to cover the activities in place to ensure the delivered product retains its quality and integrity, as well as staying within the legal supply chain throughout its distribution and storage.
A quality risk management approach should be followed to ensure that the evaluation of risks to quality are based on scientific knowledge, experience with the process and ultimately links to the protection of the patient. The level of effort, formality and documentation of the process should be commensurate with the level of risk. Examples of the processes and applications of quality risk management can be found in guideline Q9 of the International Conference on Harmonisation.
The quality system should be fully documented, with all related activities defined. A quality manual or equivalent should be established. Good documentation is an essential part of the quality system as it should prevent errors from spoken communication and permits the tracking of relevant operations during the distribution process.
All parts of the quality system must be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. This is one of the reasons that management oversight is so important.
The quality system should include a change control process so it can be adapted to changes in the business and its procedures, such as changes in the size, structure and complexity of distributor’s activities.
The management should have a formal process for reviewing the quality system and its effectiveness on a periodic basis. They must appoint a Responsible Person with clearly specified authority and responsibility for ensuring that a quality system is implemented and maintained.
2. The Responsible Person…
Each EU state has legislation that defines the qualifications and competencies required by a Responsible person, for example a degree in pharmacy is usually desirable though not essential.
A Responsible Person must –
· have appropriate experience, knowledge and training in GDP
· be given a written job description defining their authority to take decisions related to their responsibilities
· possess sufficient authority, resources and responsibility to fulfil their duties
· fulfil their responsibilities personally and should be continuously contactable. They may delegate duties but not responsibilities
· carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.
3. Outsourced Activities…
The quality system should extend to the control and review of any outsourced activities related to the procurement, holding, supply or export of medicinal products. These processes should incorporate quality risk management.
The management should have a formal process for reviewing the quality system on a periodic basis. The outcome of each management review of the quality system should be documented in a timely manner and effectively communicated internally.
4. Self-Inspections…
A self-inspection programme should be implemented covering all aspects of GDP and compliance with the regulations, guidelines and procedures within a defined time frame. Self-inspections can be comprehensive or made up of several individual inspections of more limited scope.
Self-inspections should be both impartial and detailed. Whilst audits by independent external experts can be useful, they cannot substitute for self-inspection.
All self-inspections should be recorded, capturing all the observations made during the inspection. A copy of the report should be provided to the management and other relevant persons. Should irregularities or deficiencies be found, their cause should be determined and corrective and preventive actions should be documented and acted upon.
Louise Handy…
Louise’s background is in scientific research, originally qualifying as an immunologist. She was CEO of a successful independent clinical trials unit and has held other senior management positions and Directorships in publicly and privately funded pharmaceutical & healthcare-related organisations.
Louise is Director, Chair and Fellow of the Research Quality Association (RQA). She is a regular speaker at conferences and runs her own consultancy.
