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> INDUSTRY SOLUTIONS
> DRUG QUALITY AND SECURITY ACT OF 2013 (DQSA)
The recent
focus has been on regulations relating to the US
Federal
Drug Quality and Security Act of 2013
(DQSA) Title II
Drug Supply Chain Security Act
(DSCSA),
Chinese SFDA,
Brazilian ANVISA and
emerging requirements in Europe.
The
Drug Quality and Security Act of 2013
(DQSA), sometimes referred to as
H.R. 3204, and
more specifically its Title II, referred to as
the “Drug Supply Chain Security Act"(DSCSA) was
signed into law on November 27, 2013 as US
Public Law 113-54. The new law preempts US State
laws for serializing and tracing of prescription
controlled drug products and drives federal
requirements for tracking pharmaceutical and
biologic goods.
The new US law requires
new traceability documentation for stakeholders
in the supply chain, including transaction
information (TI), transaction statement (TS) and
transaction history (TH) under certain
circumstances prior to January 1, 2015.
The law also requires changes to several
business practices and procedures relating to
verifying the authenticity of goods and
licensing verification for those who receive
prescription drug products, such as authorized
distributor of record (ADR).
Pharma Logic
Solutions has developed strategy, User
Requirement Specification (URS) and designs to
help companies comply the DSCSA.
The law
further requires that saleable drug products and
their cases are uniquely serialized and that the
information is recorded and exchanged under
certain circumstances prior to November 27,
2017.
Pharma Logic Solutions has helped
over 2 dozen leading drug and biologic
manufacturers to select solutions, define
Standard Operating Procedure (SOP), prepare Risk
Evaluation and Mitigation Strategy (REMS) and
implement new enterprise, packaging and
warehouse solutions.
This experience and
the related lessons learned will help your
company avoid costly and time consuming
mistakes.
The law drives industry n the
US to a fully certified trade system often
referred to as an e-pedigree or pedigree prior
to November 27, 2023.
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) Good Automated
Manufacturing Practice (GAMP) based
validation, and (11) vendor selection/request
for proposal (RFP).
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), Werum PAS-X, Antares Vision
(Xyntek), Laetus, ROC-IT Solutions, TAKE
Solutions, Uhlmann, Nosco,
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. |
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