A few weeks ago, the European Union made some changes to it’s “Guidelines on Good Distribution Practice of medicinal products for human use.” We realized it had been a few months since we had updated our own knowledge of these practices, and instead of read through them, stomach the information, and file the regulations away, we decided to take some notes, organize said notes, and provide you with an informative blog post.
Below are 10 key takeaways from the EU’s 2013 Good Distribution Practices for Medicinal Products. Why 10? Well, there are 10 main chapters (Chapter 11 is simply “Final Provisions”) to the European Commission’s publication, so we outlined one point you should definitely know from each.
As always, these list of ours, while we feel great content, should not be used as a substitute for official regulations or your auditor’s recommendations.
Chapter 1: Quality Management
Takeaway: “The quality system should ensure that records are made contemporaneously.”
Don’t let “contemporaneously” trip you up. The EU simply wants to make sure you record what is happening in your quality system, while it is happening. Continuous environmental monitoring, documentation of the validation and verification processes, regularly updated safety policies help ensure your medicinal products are of the highest quality. Don’t wait to record a mistake later, record it now. Later, you’ll be glad you did.
Chapter 2: Personnel
Takeaway: “The Responsible Person.”
Chapter 2, Section 2, spends a great deal of words talking about a “responsible person.” Mundane name, anything but mundane duties. This person is essential to wholesale distributors of pharmaceutical and medicinal products. The EU lists their responsibilities on Page 3 of the Good Distribution Practices, and also talks about the desired qualifications of the responsible person. Namely, this person should:
- have a degree in pharmacy
- be continuously contractible
- delegate duties (not responsibilities)
- have defined authority
Chapter 3: Premises and Equipment
Takeaway: “Calibration of equipment should be traceable to a national or international measurement standard. Appropriate alarm systems should be in place to provide alerts when there are excursions from predefined storage conditions.”
Two annoying things, but two essential components of the distribution of medical products. How do you know data is accurate if you measuring instruments haven’t been calibrated? You don’t! And how do you know that early morning shipment was kept at the right environmental conditions if you don’t have alarms? Again, you don’t.
So be sure all of your equipment used for the distribution of medicinal products has been properly calibrated, and has all the necessary alarms. 2 A.M wake up calls aren't fun, but they are necessary.
Chapter 4: Documentation
Takeaway: “Documentation should be retained for the period stated in national legislation but at least five years.”
The processes you document (including: operations standards, daily shipments, environmental temperatures) should be retained for 5 years. While that may seem like a long time, the wonderful world of hard drives and cloud computing allows less file cabinet space to be used, and less worry about accidentally throwing away documentation about an antibiotic drug an auditor will want 2 years from now. Keep things safe, secure, and easily accessible. Those three pillars for security are hard to come by, so explore different options before committing to one or many means of storage.
Chapter 5: Operations
Takeaway: Qualify your customers
For many, the checking in and out of vendors who supply the medical supplies sold to customers is a daily process. When you sell a pharmaceutical product to a customer, you obviously ask for certain information, more than just their name and favorite color. This information helps qualify them as a customer. It works similarly to when you distribute to new and existing customers. Get signatures, constantly recheck customer authorization to buy medicinal products, and be sure to monitor all your transactions. You don’t want to sell something to somebody you shouldn't be selling to them.
Chapter 6: Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls
Takeaway: “Stolen products that have been recovered cannot be returned to saleable stock and sold to customers.”
Leaving returned stolen goods lying around your distribution center, waiting to be documented, and lurking for someone to accidentally put back on the shelf with the rest of the products equals bad news for your quality department. Mistakes happen, but these kind of mistakes can be avoided. If you receive a stolen medical product, document exactly what happened (preferably while it was happening) and then follow the procedure your local regulating authority has outlined for such instances.
Chapter 7: Outsourced Activities
Takeaway: “The contract acceptor must forward any information that can influence the quality of the products to the contractor . . .”
If you hire somebody on the outside, be sure the communication pipeline between you and them is effective. Besides asking for internal audit information, auditing them yourself, documenting every step of the way, and understanding exactly the limitations of this contract acceptor, the contract giver should receive any and all product quality information. That falls on both the distributor of medicinal products, and the person that they hire.
Here’s an example: Let’s say you're a large medical product distributor who stores and ships thousands of items that are sensitive to humidity. You are looking into buying a new warehouse in the European Union, but want to make sure that during the summer, the HVAC system in the warehouse can handle keeping humidity down, and if not, where low and high values of humidity occur. You hire somebody to map your warehouse for temperature and humidity. This outside contractor does a good job providing you with all required documentation, and the process comes to an end without a hiccup. The warehouse is “recommended.” You buy the warehouse, right? WRONG! A simple recommendation is not enough! That contractor needs to provide you with any and all information they gathered (which was hopefully a lot) about product quality in that prospective warehouse. Temperature fluctuations, humidity hot spots, and at risk mezzanines should all be included in a report given to you by them, and all data collected should be looked over and analyzed.
Chapter 8: Self-Inspections
Takeaway: “Self-inspections may be divided into several individual inspections of limited scope.”
When planning a self inspection, don’t try to take on the whole world at once. Splice it up. It will allow you more time for documentation, process adjustment, and thorough changes to company policy.
Chapter 9: Transportation
Takeaway: "It is the responsibility of the wholesale distributor to ensure that vehicles and equipment used to distribute, store or handle medicinal products are suitable for their use and appropriately equipped to prevent exposure of the products to conditions that could affect their quality and packaging integrity."
Demonstrate that your stage in the supply chain of medicinal products demonstrates a lack of exposure. That means both setting standards for controlling environmental conditions and then proving those standards were enforced.
Chapter 10: Specific Provisions for Brokers
Takeaway: “[Brokers] must notify the competent authority of any changes to [address, contact, registration] details without unnecessary delay.
Who are brokers? People who work in the medical distribution process without actually handling the product. They negotiate independently on behalf of another person. While regulations are a little less intense for them, they do have to follow Directive 2001/83/EC rules (other than rules pertaining to product contact).
Looking for different information on the EU? Visit their website for a more complete understanding on their Good Distribution Practices of medicinal products for human use. If you’d like us to write a post on something EU particular, leave a comment below!