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
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.
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
Quality, Efficacy and Safety
Improve Medicine Management
Pass Your Audits
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.
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.
RECEIVE FUNDING FOR YOUR JOURNEY TOWARD REGULATORY COMPLIANCE
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.
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
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.