HOME
> INDUSTRY
SOLUTIONS > SOUTH KOREAN PRESCRIPTION DRUG
TRACKING
The
recent focus has been on regulations relating to
the South Korean the Ministry of Health and
Welfare notification 2011- 58 amending
"Controlling and indicating barcodes of
pharmaceutical products" sets the law relating
to drug traceability."
Under the law,
pharmaceutical barcode or RFID tag must be
adhered to primary, secondary and external
containers as well as packaging materials, per
items, and per packaging units. Likewise,
expiration date and lot number information is
mandated in bar codes for traceability of
specified drugs from 2012 and prescription drugs
from 2013, respectively.
Manufacturer
must adhere or indicate barcode or RFID tag to
distributed pharmaceuticals that are
domestically manufactured or imported (excluding
high pressure gas for medical use, drug
substances manufactured just for other
manufacturing process, herbal medicines, product
for clinical trials). However, pharmaceutical
barcode or RFID tag can be omitted for empty
capsules.
Pharmaceutical barcode or RFID
tag must be adhered to primary, secondary and
external containers as well as packaging
materials, per items, and per packaging units.
There are several very
specific requirements for manufacturers and
wholesalers that will be defined based on your
company procedures and business systems.
Projects have
delivered (1) strategy, (2) project roadmap and
plans, (3) User Requirement Specification (URS)
for (a) enterprise serialization, (b) packaging
systems, (c) warehouse/shipping (referred to as
EDGE), and (d) regulatory reporting such as
e-pedigree, (4) contract manufacturer and
logistics provider requirements and governance,
(5) compliance with global regulatory
requirements, (6) functional and design
specifications, (8) business system and
packaging designs and architectures, (9) pilot
planning and scenarios, (10) GAMP based
validation, and (11) vendor selection.
Projects have included solutions involving
serialization, track and trace, electronic
pedigree (e-Pedigree), country traceability
reporting (i.e., Turkish Ministry of Health,
China, etc.), radio frequency identification
(RFID), barcoding and scanning, GS1 electronic
product code information services (EPCIS),
supply chain, warehousing and Electronic Data
Interchange (EDI). Pharma Logic Solutions is a
longstanding Solution Provider for GS1 US
Healthcare.
Strategy, business and
user requirements, designs and implementations
have included solutions from SAP (ECC, SCM, Aii,
OER, Aie), JD Edwards, Oracle (OPSM, OPM),
Manhattan Associates, MAPICS, Acsis
(ProducTrak), Axway, rfXcel, Frequentz, Systech, Optel Vision (TrackSafe, Line
Master, PharmaProof), Cognex, Mettler Toledo,
Seidenader (Körber Medipak), Antares Vision
(Xyntek), Laetus, ROC-IT Solutions, TAKE
Solutions, Uhlmann, Nosco, Werum PAS-X,
Tracelink, Videojet and others.
Contact us to
discuss your needs and contrast the
Pharma Logic Solutions solutions against previous providers to
see why our approach is the
ideal solution. |
