28 BioPharm International Quality and Regulatory Sourcebook eBook March 2022 www.biopharminternational.com
• Standards/guidelines—In the
f ield of pharmaceutical GDP,
there are a lot of regulatory and
industry guidelines but precious
few independent standards with
the upshot that there is a variety
of different approaches and inter-
pretations. MMCS is investigat-
ing the creation of an overarching
generic standard (or standards)
covering pharma GDP processes
and behaviors from a strategic
perspective, and then underpin-
ning this umbrella prescript with
a series of technical standards as
necessary. The fundamental keys
being universality, repeatability,
and consistency.
• Shared audit platform—A sup-
pl y- c h a i n a u d it s c h e m e i s
expected to form an important
element of the MMCS program
with an important role in ensur-
ing GDP–compliancy to a rec-
ognized industry standard. The
MMCS team is currently assess-
ing the demand and potential for
a shared audit platform where the
industr y can mutually accept
independent audit results and
absolve the audited parties from
having to endure multiple assess-
ments from different principles.
Such a common resource means
that a successful audit would
confer an industry-recognized
compliancy status.
• Certif ication—Certif ication is
a frequent requirement of phar-
ma-logistics customers who need
their suppliers to demonstrate
that they have the appropri-
ate quality systems in place and
can meet pre-defined standards.
Such conformity verification has
an important role to play, and
third-party certification will be
another important element of the
MMCS program. The design of
the MMCS certification scheme
will fully reflect the need for true
program objectivity and 'real-
life' legitimacy of the process and
results.
• Training—GDP training is a
core pillar of the MMCS pro-
gram which is seeking to work
closely with established training
organizations and specialists to
develop the necessary agenda,
content, and formats for differ-
ing regions and markets. This
training component will be man-
aged by the well-established BSI
Training Academy, which has a
global reach and trains more than
200,000 people every year with an
unrivalled portfolio of courses.
• S u p p l y c h a i n q u a l i f i c a -
tion—According to the United
K i n g d o m's M e d i c i n e s a n d
Healthcare products Regulatory
Agency (MHRA) (7) , "this is
one of the highest risk areas of
Good Distribution Practice."
Yet despite this risk, end-to-end
management of supply chain
GDP is one of the weakest
areas of regulatory compliance.
Although it is the responsibility of
licensed MAH and WDA orga-
nizations to qualify and periodi-
cally re-qualify their end-to-end
supply chains in accordance with
GDP and written technical agree-
ments, it is extremely difficult,
Quality and Regulatory Sourcebook Regulations: Supply Chain
Figure 3. The interrelated constituent elements of the Multi-Mode
Compliance & Standards (MMCS) program.
Visit BioPharmInternational.com to read the following articles about the
biopharmaceutical supply chain:
• Finding Solutions to Cold Chain Supply
www.BioPharmInternational.com/view/finding-solutions-to-cold-
chain-supply
• Serialization and Aggregation from a Manufacturing Perspective
www.BioPharmInternational.com/view/serialization-and-
aggregation-from-a-manufacturing-perspective
• Track-and-Trace Progress Benefits Supply-Chain Security Efforts
www.BioPharmInternational.com/view/track-and-trace-progress-
benefits-supply-chain-security-efforts
—The Editors of BioPharm International
More on the Supply Chain
