martes, 30 de enero de 2024

Good Distribution Practices (GDP) & Good Manufacturing Practices (GMP)

 

Good distribution practices (GDP) and good manufacturing practices (GMP) are quality standards and guidelines that have the same objective, to ensure medical device and pharmaceutical products are safe, meet their intended use, and comply with regulations.

GMP focuses on manufacturing processes, while GDP covers distribution activities.

Good manufacturing practices involve consistently producing products that meet quality standards. This requires the implementation of a system where the aim is to minimize risks, from incorrect labelling of products to contamination to incorrect ingredients and everything in between. GMP cover all parts of the production process, from raw materials through to the production of the finished product.

Good distribution practices involve maintaining the quality and integrity of products through all stages of the supply chain. GDP applies to warehousing, storage, and transportation, and it covers everything from storing and transporting products under the right conditions and ensuring product integrity at the correct destination on time.

There are parts of GDP that are unique, so they don’t apply to GMP. Those unique parts of GDP include guidance on transportation covering aspects such as temperature control, vehicle controls, and conducting risk assessments on transport routes.