INSIDER INSIGHT
SECTION TITLE
Good Distribution Practices
The EU Commission has revised the Guidelines on Good Distribution Practice (GDP), reflecting today’s more complex supply chains. The new GDP were published on March 7, 2013, requiring industry adherence within six months. The prior guidance was in place for 19 years and many of the requirements had been annexed and expanded throughout the years, making initial GDP requirements cumbersome to interpret.
The required storage conditions for medicinal products should be maintained during transportation within the defined limits as described by the manufacturers or on the outer packaging.
• If a deviation such as temperature excursion or product damage has occurred during transportation, this should be reported to the distributor and recipient of the affected medicinal products. A procedure should also be in place for investigating and handling temperature excursions.
• Risk assessment of delivery routes should be used to determine where temperature controls are required. Equipment used for temperature monitoring during transport within vehicles and/or containers, should be maintained and calibrated at regular intervals at least annually.
• Dedicated vehicles and equipment should be used, where possible, when handling medicinal products. Where non-dedicated vehicles and equipment are used procedures should be in place to ensure that the quality of the medicinal product will not be compromised.
• Where transportation is performed by a third party, the contract must encompass requirements of Chapter 7. Essentially, the wholesale distribution should make transporters of the relevant transport conditions applicable to the consignment. Where the transportation route includes unloading and reloading or transit storage at a transportation hub, particular attention should be paid to temperature monitoring, cleanliness and the security of any intermediate storage facilities.
• Provision should also be made to minimize the duration of temporary storage while awaiting the next stage of the transportation route. Containers should bear labels providing sufficient information on handling and storage requirements and precautions to ensure that the products are properly handled and secured at all times. The containers should enable identification of the contents of the containers and the source.
Serialization
While serialization - the global track and trace regulations to protect patient safety and ensure product integrity - will be a standard requirement for the global drug supply by the end of the decade, the serialization requirements themselves will be far from standard. Serial number formats vary widely from GS1 global standards to unique ver- sions in China and Brazil. In most countries, the manufacturer can create the serial numbers themselves but in China, they must request the numbers from a CFDA system. Packaging hierarchies requiring serialization range from solely unit level application to multi-tier
pharmoutsourcing.com | 33 | July/August 2016
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