Good manufacturing practice

quality output in pharmaceutical manufacturing


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. 


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: 

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.  


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.

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 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


  • 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

Frequently Asked Questions

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. 

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