Resources, guidance and updates from the GDP community.
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...
Guidance
How to be a Broker in Good Distribution Practice If you are interested in becoming a broker in the pharmaceutical industry, you need to be aware of the legal and quality requirements that apply to your activities. Brokers are intermediaries who...
Guidance
Management Reviews are important in Pharmacovigilance One of the key elements of a robust pharmacovigilance system is the Management Review, which is a periodic and systematic evaluation of the performance, adequacy and effectiveness of the system...
Guidance
‘Quarantine’ in Good Distribution Practice Quarantine is a term that is often used in the context of public health, but it also has a specific meaning in the pharmaceutical industry. According to the EU Guidelines on Good Distribution Practice of...
Guidance
Your Outsourced Third-Party Services and ProvidersOutsourced Activities is a common practice in the pharmaceutical industry, where companies may delegate some of their activities to third-party service providers. These activities may include...
Guidance
It’s not a comforting site, is it? It’s a very hot day, everyone wishes they were already there, and the snaking line of glass and metal winds its way off into the distance. You're transporting medicine, but it’s going to be quite a while yet…
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