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.
Outsourced Activities: How to Manage them
Outsourcing is a common practice in the pharmaceutical industry. It can offer many benefits, such as cost reduction, efficiency improvement, and access to specialized expertise. However, outsourcing can also pose challenges and increase risks if you select poorly or do not fully understand the activity you plan to outsource.
Customer Service Complaints in GDP
Complaints can indicate serious quality issues, regulatory breaches, or customer dissatisfaction. They are inevitable in any business, but they can be especially damaging for wholesalers and distributors of medicinal products. it is essential to have a robust and effective complaint handling system that complies with GDP.
Why Management Reviews are Important
An element of a pharmacovigilance system is the Management Review, which is a systematic evaluation of the performance, adequacy and effectiveness of the quality system. It’s the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects and other related problems.
Medicinal Product Recalls: What, Why and How
A medicinal product recall is a process of removing or correcting a defective or unsafe medicinal product from the market. Recalls may affect all or part of the supply chain, from manufacturer to end-user.
A recall may be initiated by the manufacturer, the distributor, the marketing authorisation holder (MAH).
Warehouse Cleaning to GDP Standards
Warehouse cleaning is an essential part of maintaining good distribution practice (GDP) standards for the storage and transportation of pharmaceutical products. Cleaning your Warehouse helps to prevent cross-contamination, degradation and damage to medicinal products from dust, particulates, careless disposal of waste, and early detection of pestilence ingress.
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...