good distribution practice (GDP) requirements for Wholesalers Offer a Superior Service That is Legally Compliant With National & EU Regulations Earn Respect For Your Company By Operating With Ethical Integrity Be Consistently Efficient with Effective Management Systems In Place Get Started Good Distribution Practice (GDP) OVERVIEW Good Distribution Practice (GDP) outlines the minimum standards that a wholesale distributor must follow to guarantee the quality and integrity of pharmaceutical products are maintained throughout the supply chain. When your company – regardless of its size – is compliant with GDP regulations, you ensure that medicines in the medical supply chain are authorised in accordance with European Union (EU) legislation and that storage and transportation are handled in a way that limits contamination by or of other products, amongst other advantages. BENEFITS OF Good Distribution Practice (GDP) GDP compliance is a legal obligation which carries a variety of benefits, both for your business and your stakeholders. These are a few of the inherent compliance benefits you may expect: Avoid Cross-Contamination To avoid the risk of cross-contamination, Good Distribution Practice (GDP) employs an inter-connecting quality system which ensures that products are appropriately stored and handled at all times. Learn More Quality, Efficacy and Safety Good Distribution Practice (GDP) conformity reassures patients that they may depend on the quality, efficacy and safety of all the products provided. Learn More Improve Medicine Management Being compliant with Good Distribution Practice (GDP) means that medical products always maintain the right level of temperature and humidity, and are properly handled throughout the medical supply chain. Learn More Pass Your Audits External audits may occur at any time. However, if your organisation has met all of its compliance regulations, you will always be prepared for an audit and will ensure that it passes smoothly. Learn More MDRP Certified Expert Being a Medical Device Registered Person (MDRP) with the Medicines Authority, Luke specialises in the compliance for medical devices. Combining his expertise in management systems with his knowledge of medical device regulations, Luke has never failed to help his clients achieve compliance. He holds over 12 years of experience in the implementation of standard management systems, and has worked on both Medical device regulations and in-vitro diagnostic regulations since before their launch in May 2021 and 2022 respectively. Get in touch RECEIVE FUNDING FOR YOUR JOURNEY TOWARD REGULATORY COMPLIANCE As a Malta Enterprise approved advisor, Luke can help his clients reap the full benefits of currently available funding. Applicable to any business based in Malta, the Government of Malta’s current funding schemes have never been better. The precise amount depending on your company’s size and ownership structure. For more information, simply get in touch for a free consultation session! Luke will help you to make the most of the best available funding incentives applicable to your business. Get in touch RECEIVE FUNDING FOR YOUR JOURNEY TOWARD REGULATORY COMPLIANCE Luke’s approval as a Malta Enterprise approved advisor means that his clients can reap the full benefits of currently available funding schemes. Find out whether you are eligible for funding, by getting in touch with Luke! Get in touch Funding Opportunities For pioneering companies, getting ISO 9001 certification is a crucial milestone. Recognizing the importance of working towards this standard, there are various funding opportunities to be found in Malta. These include:50% Tax Credits by the Government of Malta.cash grants by Malta Enterprise, JobsPlus, & other entities. Enquire A Closer Look at Good Distribution Practice Regulations Why is a GDP certification required? Unlike ISO certification, Good Distribution Practice (GDP) is not a choice but a legal requirement for companies involved in the wholesale or distribution of pharmaceutical products. With the new publication of medical device regulation, for Malta and all other EU Members, this has become even more crucial. Achieving GDP CERTIFICATION What does compliance guarantee Companies involved in the pharmaceutical supply chain continue to comply with EU legislation. Medical products are maintained at the correct temperature and humidity levels throughout their life cycle, whilst proper handling methods are used. The medical products are not subject to contamination. Products entrusted to approved wholesalers are not stored for prolonged periods of time, and are therefore consumed well within their expiry date. The right products reach their clients in a timely manner Good Distribution Practice Articles February 16, 2023 Avoid these 10 Pitfalls when Implementing an ISO Management System Read More February 8, 2023 How-To: Clause 8 Management System Options in ISO 17025 Read More January 20, 2023 Why you Need to get Certified – ISO 9001 Question and Answer (Part 1) Read More January 2, 2023 The Striking Differences Between ISO 15189 and ISO 17025 Read More December 18, 2022 Secure Success with ISO 15189 Accreditation for Medical Laboratories! Read More September 26, 2022 Useful Tips for Measurement and Uncertainty in ISO 17025 Read More September 19, 2022 ISO 17025 Laboratory Sampling Requirements – Fit the Bill! Read More September 14, 2022 How-to: Process Requirements of Clause 7 in ISO 17025 Read More September 14, 2022 Requirements of ISO 9001 as a Quality Management System – The Road to Continuous Improvement Read More Frequently Asked Questions What is Good Distribution Practice? Good Distribution Practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain. Who will verify compliance? The Medicines Authority verifies compliance in Malta.