There has been a significant increase in regulatory oversight and pharmacopeia standards for medicinal products to include proper handling, storage and distribution as an extension of their manufacturing.
It is of key importance that medicinal products are not only made to a high quality in accordance with Good Manufacturing Practice (GMP), but that the quality and integrity of these medicinal products are maintained through the entire supply chain to the end-user.
This is where Good Distribution Practice (GDP) comes into play. Given the importance of the GDP regulatory requirements, the creation of a Master Shipping Validation Plan (MSVP) can provide a road map for designing and qualifying insulated packing for temperature-sensitive medicinal products and also serve as a guidance document to provide meaningful temperature profiles for medicinal products in distribution to support your current business practices. This article will discuss some of the GDP aspects of developing of this Master Shipping Validation Plan
Elements of the Master Shipping Validation Plan
Medicinal products are required to be transported in such a way that maintain and control the environmental conditions that may affect product quality and safety in the shipping and distribution system. To meet the current GDP regulatory requirements, transportation providers or containers or packaging configurations are required to be qualified.
Transportation procedures should also be qualified to ensure that appropriate conditions/temperatures are maintained under probable extremes of ambient temperature. In order to develop a Master Shipping Validation Plan (MSVP), the following elements of the Master Shipping Validation Plan should be included, but are not limited to:
- Introduction including background, purpose and the scope
- Description of Shipping Materials
- Glossary of Terms
- Risk Assessment and Qualification
- Responsibilities
- Shipping Validation Plan Design
- Shipping Process Description
- List of Equipment/Supplies
- Qualification of New Customer/Shipping Carrier
- Thermal Profile Study Design
- Thermal Profile Testing Data Assessment and Processing
- Thermal Testing Reporting
- Supporting QA Programs
Elements of Shipping Study Design
In order to develop a meaningful thermal profile for use in shipping performance qualification study, the following elements should be included are considered as follows, but are not limited to:
- Temperature conditions at origin (sending site) and destination point
- Geographic region of shipping lane chosen
- Transit temperature requirements of the products being shipped
- Total duration of transit
- Transport routes and modes (overnight air, ground, international, etc.)
- Product handling and logistics at various handlingstopover points along routes
- Estimate times of transport for each segment of the trip
- Estimated minimum and maximum ambient temperatures that may be encountered in each segment
- Minimum and maximum products loads
- Seasonal temperatures (winter vs. summer)
- Quantity and placement of refrigerants
- Conditioning of components (the process of bringing components such as shipping container and gel packs to a specific temperature before starting the packing process)
- Shipment container used
- Insulated shipping container interior packaging configuration
- Placement of temperature monitoring devices during shipping
Shipping Plan Matrix Design
The key element of the Master Shipping Validation Plan (MSVP) is to develop a shipping plan matrix for performing thermal profile study for use in shipping performance qualification study. Product impact should be assessed for shipping conditions during the storage, shipment, and distribution process. Multiple shipments using different size of the shipping packaging systems (e.g. small, medium and large) will be sent along those chosen shipping lanes (e.g. the longest transit time, different geographic regions and so forth) to determine each pre-defined packing configuration (e.g. 2 – 80C, 15 -300C and so forth) capabilities in maintaining target payload temperatures.
From a GDP perspective, each size shipping packaging system in each configuration should be sent to each destination in triplicate. Each of these shipments will be sent on separate days to ensure some variation in the challenges faced by each pre-defined shipping packaging system.
Many pharmaceutical companies are facing the challenge of managing transportation and delivery of temperature-controlled products through their own shipping and distribution system (which might include handing off to its specified wholesaler) to their customers.
To meet the current GDP regulatory requirements, shipping conditions should be monitored continuously through all shipping routes, unless it was validated under supply chain validation. The development of a Master Shipping Validation Plan (MSVP) can provide a road map for designing and qualifying insulated packing for temperature-sensitive medicinal products to meet the challenges of the current GDP regulatory requirements.
