Resources, guidance and updates from the GDP community.
Guidance
GDP Compliance in Documentation Documentation is an essential part of GDP, as it provides evidence of the actions taken by the distributor to demonstrate compliance with the applicable regulations and guidelines. Documentation also facilitates...
Guidance
Temperature Control: Why is it important? Storing and transporting medicinal products at the right temperature is essential for ensuring their quality, safety and efficacy. Medicinal products are sensitive to temperature changes and may lose their...
Guidance
A responsible person (RP) is a key figure in the pharmaceutical supply chain, who ensures that the quality and integrity of medicinal products are maintained throughout the distribution process. The RP is named on the wholesale distribution...
Guidance
The Importance of a Healthy and Compliant QMS A quality management system (QMS) is a set of policies, procedures and processes that aim to ensure that the quality and integrity of products and services are maintained throughout their lifecycle. A...
Guidance
What Can We Do about Counterfeit and Falsified Medicines?Counterfeit and falsified medicines are a global problem that poses serious risks to public health and safety. They are products that are deliberately and fraudulently mislabelled with respect...
Guidance
Risk Assessment within a Good Distribution Practice Environment. Good Distribution Practice (GDP) is the minimum standard that a wholesale distributor must meet to ensure that the quality and integrity of medicines are maintained throughout the...
Guidance
Customer Service Complaints in Good Distribution Practice Customer service complaints are inevitable in any business, but they can be especially damaging for wholesalers and distributors of medicinal products. Complaints can indicate serious quality...
Guidance
Cold Chain Storage of Medicinal Products in Wholesale Cold chain storage is the process of maintaining the quality and integrity of medicinal products that require lower than ambient temperatures throughout the supply chain. This includes the...
Guidance
Data Integrity -Compliance in GDP Data integrity is the degree to which data is complete, consistent, accurate, trustworthy and reliable, and that these characteristics of the data are maintained throughout the data lifecycle. Data integrity is...
Guidance
The Transportation of Medicines in Good Distribution Practice Medicines are essential for the health and well-being of millions of people in the UK. However, medicines are also sensitive products that require careful handling and storage throughout...
Guidance
Change Control in GDP (Good Distribution Practice): What You Need to Know.If you are involved in the distribution of medicinal products, you may have heard of the term “change control”. But what does it mean and why is it important for ensuring the...
Guidance
ISO 13485 and your Quality Management SystemThe European Union Medical Device Regulation (EU MDR) is a new set of rules that came into force on May 26, 2021, replacing the previous Medical Device Directive (MDD) and Active Implantable Medical Device...
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