Japan: A new standard for the pharmaceutical industry aims to protect consumers by ensuring safety during transportation and storage of products.
Orally ingested food and drug products have the potential to negatively impact the health of consumers. To protect the population, strict quality control during the production process and transport of pharmaceuticals is required.
The TAPA Asia Pacific Japan chapter developed the Food and Drug Security Requirements (FDSR) eight years ago. Since then, they have assisted many food and drug organizations in meeting the requirements. This year, they have established a working group to assist with adherence to Good Distribution Practice (GDP) enforced by the EU for pharmaceuticals.
The World Health Organization (WHO) announced their distribution guidelines and EU commenced legal enforcement of the GDP requirements. While Japan has a number of laws, guidelines, and standards for the industry, the ratification of PIC/S-Pharmaceutical Inspection Convention, the Pharmaceutical Inspection Cooperation Scheme, and the global growth of the industry require conformance with GDP.
The quality of pharmaceuticals can deteriorate due to transport equipment or facilities, and a stable supply chain can be disrupted or diminished by counterfeiting, theft, and other issues. GDP is required as a general standard for transporting/storing facilities, transporters, vessels, transporting ways and indications to combat these issues. Incidents of counterfeit or stolen medication occur at a much lower rate in Japan than other countries. As a result, the Japanese initiative for managing distribution is focused on controlling temperature during transport and storage.
The guidelines for temperature management include:
- Maintaining suitable temperatures in storage areas
- Consistent temperature monitoring of suitable points in storage areas
- Utilization of alarm systems for detecting temperature irregularities
- Validation of computer systems
- Periodic adjustment of monitoring and alarm systems
The TAPA Asia Pacific Japan chapter plans to release a report detailing results of the working group’s study of equipment and systems concerning transportation security.
The Transported Asset Protection Association (TAPA), a non-profit organization, is a unique forum that unites global manufacturers, logistics providers, freight carriers, law enforcement agencies, and other stakeholders with the common aim of reducing losses from international supply chains. For further information visit https://www.tapa-global.org/
Mr. Derick Ding
TAPA Asia Pacific
Tel: +65 65149648