Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Blog
Take a look through our free blogs that cover a number of different areas of Good Distribution Practice (GDP). Each blog addresses primary topics including training, inspections and procedures. If you need any more information or any assistance/training don’t hesitate to contact us by email or phone.
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. It Ensures the quality, safety, and efficacy of all medicinal products, all of your digital data, and all paper-based systems in all its forms. All data is to be stored for 5 years as a minimum, including generated software.
What is Quarantine in Good Distribution Practice?
According to the EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use, it’s “…the status of starting or intermediate materials, or packaging materials, or finished products, isolated physically or by other effective means whilst awaiting a decision on their release or rejection”.
GDP Transportation of Medicines
Medicines are highly sensitive products that require careful handling and storage throughout their supply chain, from the manufacturer through to the end user.
The transportation vehicle is considered to be an extension of the supplying warehouse and the driver has sole responsibility for the goods on board whilst in transit.
CEIV Pharma IATA
The IATA CEIV Pharma certification (or IATA Centre of Excellence for Independent Validators in Pharmaceutical Logistics) is provided by IATA, enabling those transportation providers to undergo a regulated audit programme, to ensure adherence to strict GDP compliance, quality management and handling controls when distributing pharmaceutical products and medical devices.
Temperature Control for Ambient Medicinal Product Storage
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 be compromised if exposed to extreme or inappropriate...
What are GDP Guidelines for Medicinal products?
Good Distribution Practice (GDP) guidelines for medicinal products are a set of rules and recommendations that aim to ensure the quality and integrity of medicinal products throughout the distribution chain. These guidelines cover all activities related to the procurement, holding, supply, or...
Self-inspections (First-Party Audits)
These guidelines aim to ensure that the quality and integrity of medicines are maintained throughout the supply chain, from the manufacturer to the end user. Conducting regular self-inspections and first-party audits of your own operations and processes, are important tools for GDP compliance and continuous improvement.
How to be a Broker in Good Distribution Practice
Brokers are intermediaries who arrange transactions between buyers and sellers of medicinal products, but do not take physical possession of the products or own them at any point. They can operate within the UK, within the EU, or between the UK and third countries, depending on the type of products and the market conditions.
What is a WDA (H) (Wholesale Distribution Authorisation)?
The purpose of the requirement to hold a WDA (H) is to ensure that the regulations and guidelines relating to the procurement, supply, holding and export of medicinal products are upheld, and that the quality and integrity of the medicines are maintained throughout the supply chain, from the manufacturer to the end user.
Why Good Distribution Practices Matter for Pharmaceutical Products
Good Distribution Practice means that from the manufacturer to the wholesaler, from the wholesaler to the retailer, and from the retailer to the patient, every step of the distribution process must ensure that the medicines are handled, stored, and transported under suitable conditions, as required by the marketing authorisation or product specification.