Additional InformationHealthcare Packaging Regulations and Traceability Methods Vary Globally
Global pharmaceutical companies must deal with vast and complex legislations that may change
unexpectedly. Two of the largest regional healthcare packaging markets, North America and
Western Europe, are pursuing two different methods of accountability and traceability of healthcare
packaging throughout its supply chain.
The European healthcare packaging solution to traceability of pharmaceutical products is mainly
driven by unique serialisation of packaging. For example, packaging may contain a unique product
number, and/or a unique barcode, QR code etc. that can be checked off the manufacturer’s
databases for verification before dispensation by a healthcare professional. The US market tends
to more inclined towards verification at each step in a supply chain. Global Healthcare companies
must adapt their packaging lines to suit individual markets, adding expense, complexity and
potential errors to operations.
Accudial Pharmaceutical Inc.
Air Packaging Technologies Inc
Becton & Dickinson,
Berry Plastics Corporation
Cardinal Health Inc.
CWS Packaging Inc
Firstan Quality Packaging
Johnson and Johnson
Manufacturing Applications eXperts, Inc.
Ruby Macons Limited,
Schaefer Technologies, Inc.
Schott Pharmaceutical Packaging
West Pharmaceutical Services
Other Organisations Mentioned in This Report
Agência Nacional de Vigilância Sanitária (ANVISA) (The Brazilian National Health Surveillance Agency)
Australia New Zealand Therapeutic Products Authority (ANZTPA).
Australian Department for Health
China Food and Drug Administration (CFDA)
China Department of Drug Safety and Inspection
Communist Party of China
Food and Drug Administration (FDA)
National Health Service (NHS)
Therapeutic Goods Administration of Australia (TGA).
USA Centres for Disease Control and Prevention (CDC)
World Health Organisation
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