What is Good Distribution Practice (GDP)?
Good Distribution Practice Training is a requirement for all personnel involved in the wholesale distribution of medicinal products.
Good Distribution Practice is defined as: “Dealings with the guidelines for the proper distribution of medicinal products for human use. Good Distribution Practice is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption”.
How do we implement GDP within our company procedures?
Good Distribution Practice is outlined in the EU Guidelines (2013/C 343/01) which includes 11 chapters of guidance, each covering a different area(s) of operations. These chapters are designed to ensure safe practices across your company, safe handling of medicinal products and patient safety, as well as helping you to maintain quality standards within your business.
Good Distribution Practice training on the guidelines is essential in making sure you know how to implement GDP effectively into your procedures. If you are new to wholesaling and are thinking of starting your own company, researching the guidelines will ensure you know what the process will involve and the work that you will need to put in.
The guidelines are used by the MHRA to cross reference your operations/documents during inspections. They should be followed throughout the company to not only ensure that you maintain a WDA and your licences but, more importantly, for the safety of the patients that will be using the products. If the integrity of the product is compromised or falsified medicines enter the supply chain (due to deviations/failings) it could put the patients at risk.
Below is the list of the 11 Chapters of the EU Guidelines (2013/C 343/01):
- Quality Management
- Personnel
- Premises & Equipment
- Documentation
- Operations
- Complaints, Returns, Falsified Medicinal Products, Product Recalls
- Outsourced Activities
- Self-Inspections
- Transportation
- Provisions for Brokers
- Final Provisions
Initial and continuous Good Distribution Practice training is a requirement for anyone involved in ANY wholesale distribution activities.
If you require initial/refresher Good Distribution Practice training, which will be needed if you are not up to date with the EU Guidelines (2013/C 343/01), we can provide this for you. Take a look at our training calendar to find out when our next sessions are, or if there is a large group that needs training we can arrange to come to you. Our face-to-face courses run over two days and cover the 10 workable chapters in the EU Guidelines, with each one being broken down into multiple slides, as well as including the expectations of the MHRA in regards to GDP compliance. We like to use some practical sessions to further aid your understanding of Good Distribution Practice.
Evidence-based Training
If you’ve recently had Good Distribution Practice training, how do we know that you are competent in the subject you have been trained on? The MHRA are looking for competency based training so you must be able to provide evidence that the training actually happened and that you are competent in the subject matter, e.g. have something that shows you passed the course. (See our blog “The Inspector Has Asked” in LinkedIn).
This can be done with a certificate and/or proof of a test (paper or online), which is something that we give out when you successfully complete a course. In our courses you will complete pre and post training tests to show improvements in your knowledge from the training.
Further Assistance and Support
Knowledge on Good Distribution Practice should be continuously updated with refresher training for anyone who is involved in any activities that relate to wholesale distribution. Staff members should have further relevant training before taking on any new roles or tasks, particularly if they will require new specialist skills/knowledge. You must keep a record of all training courses taken by every employee.
Your company should be continuously compliant and audit/inspection ready.
Our online training courses allow you to choose from a range of topics, including courses aimed at specific job roles, to find which one is most suited to your needs. Click on the “Visit GDP Training Courses” button below.
Need help? Give our dedicated team a call on – 0330 1330 920 or email us using the contact form below with your details and your query.
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Related Courses
GDP for RPs and Management
GDP for RPs and Management covers topics that will help you with GDP compliance, such as Falsified Medicines, Deviations and Documentation. It gives more detail on what is included in the EU Guidelines 2013/C 343/01.
Falsified Medicines
Detecting Falsified Medicines could be said to be an "art" all in itself. Most are very convincing and extremely difficult to spot. The Falsified Medicine course will show you what to look for in order to positively identify a Falsified Medicine, and what the correct procedures are in order to correct deal with them.
Introduction to Auditing
Discover the elements and requirements of Auditing. This programme aims to focus on the critical elements of the auditing process, showing you what to look for and to identify problems in the QMS or GDP of a licensed premises.
