Good manufacturing practice quality output in pharmaceutical manufacturing Offer a Superior Service That is Legally Compliant With National & EU Regulations Be Consistently Efficient with Effective Management Systems In Place Earn Respect For Your Company By Operating With Ethical Integrity Get Started GOOD MANUFACTURING PRACTICE OVERVIEW Good Manufacturing Practice (GMP) describes the minimum legal requirements that pharmaceutical manufacturers must comply with throughout their manufacturing processes. Outlining a system which ensures that products are consistently produced according to quality standards, complying with GMP regulations will also automatically prove your legal compliance and add to your company’s trustworthiness. BENEFITS OF GOOD MANUFACTURING PRACTICE GMP 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: Monitor High-risk Cases Good manufacturing practice will prioritise the inspections of medicine manufacturing sites for cases with higher risks. Learn More Quality, Efficacy and Safety This practice reassures patients that they can depend on the quality, efficacy and safety of all medicines. Learn More Eliminate Public Health Risk Good manufacturing and distribution practice will help identify and address problems at manufacturing sites in order to eliminate any public health risk. .Learn More Lower Administrative Costs Good manufacturing and distribution practice reduces the administrative costs and burdens that pharmaceutical manufacturers have to face. 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 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 manufacturing practice regulations Why is a GMP Certification required? Unlike ISO certification, Good Distribution Manufacturing Practice is not a choice but a legal requirement for companies involved in the manufacture 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 gmp 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 Manufacturing 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 Manufacturing Practice? Good Manufacturing Practice (GMP) describes the minimum standards that a pharmaceutical manufacturer must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.