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Managing Contract Partners: McKinsey & Co.: Tools for Meeting
http://www.pharmamanufacturing.com/articles/2012/141.html http://www.pharmamanufacturing.com/articles/2011/070.html
11 20
Delivering Patient Value in McKinsey & Co.: Four Steps to
24
by Hedley Rees) Additional Resources
Pharmaceutical manu-
facturers are outsourc-
ing more critical functions
to contract manufactur-
ing organizations. How
are they monitoring qual-
ity and performance, and
what are the best prac-
tices for communication
and knowledge transfer?
6000
5000
figure 1
Number of Recalls
4000
3000
1000
19 19 19 19 19 19 19 19 19 20 20 20 20 20 20 20 20 20
91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08
Year
100
figure 2
75
52%
45.5%
50 35.8%
30.9%
23.6% 22.8%
25 13%
0 Our QMS soft- We use risk We have a formal We closely define We integrate We transfer We monitor and
ware and relevant management framework in process validation our CAPA internal best train key CMO
IT are linked to tools internally place to transfer and change con- systems with practices to our partners and
those of critical and with sup- our best practices trol requirements those of key critical CMOs suppliers in areas
CMOs and sup- pliers to pre- internally for CMOs CMOs and suppliers where improve-
pliers vent issues ment is needed
gies. “Even though ICH Q9 was pub- opportunities. It should never be-
lished six years ago, drug manufac- come a hammer in search of a nail,
turers are just starting to find their and all systems must be evaluated
footing in the areas of risk manage- if it is to be robust.”
ment, quality by design and quality
systems,” said Long. Their progress, Managing contract manufacturers
he says, depends on how advanced requires asking two key questions,
they are in applying risk manage- according to Hedley Rees, consul-
ment tools and concepts. tant and founder of the U.K.-based
consultancy, Biotech PharmaFlow,
“If you do not have an adequate who established and chairs the Drug
quality system in place, with ade- Industry Modernization group on
quate controls, all the product and LinkedIn and whose extensive book
process development, and the pro- on optimizing pharmaceutical sup-
cess understanding in the world, ply chain management was published
may go to waste,” he told attendees two years ago6:
at PDA’s annual meeting earlier this
year in Phoenix. 1) D
o I understand the extent of my
obligations to manage my CMOs?
In addition, he says, some profes- 2) H ave I the right processes in place
sionals have fundamentally mis- to deliver on those obligations?
understood the concept of a ‘risk-
based approach,” Long says. “It is All manufacture and testing carried
not a gift card for reducing test- out at third parties must be treated as
ing and other precautions,” he said. if they were carried out by the drug
“Instead, it requires a balance be- manufacturer itself, Rees says, and the
tween identifiying and mitigating working supply chain must comply to
threats, while taking advantage of regulations at every stage. This means:
100
figure 3
75
48.7%
40.3% 42.9%
50 37.8%
26.1%
17.6% 17.6%
25
0 FMEA Risk MaPP, Six Sigma Process Capability Modeling and Quality by Design Process Analyti-
heat maps Analysis Simulation for projects that cal Technology
go from develop- (PAT)
mental to com-
mercial stages
When asked how closely they syn- As far as specific risk management
chronized their internal quality sys- tool kits and methods are concerned
tems with those of CMOs and suppli- (Figure 3), 49% of respondents said
ers (Figure 2), 64% of respondents they were using failure modes and
said they defined process validation effect analysis (FMEA), 43% are using
and change control requirements process capability analysis, 40% are
closely for their CMOs; 46% said they using Six Sigma, 38% say they use
used risk management tools inter- QbD, and 36% report using process
nally and with suppliers. analytical technology (PAT).
100
figure 5
75
57.5% 60.9%
57.5%
50
25 19.5%
9.2%
0
Senior quality staff We review relevant We hold meetings We have set up Other
members from our CMO/supplier manufac- with key CMOs dashboards to facilitate
company visit turing and process moni- and suppliers KPI monitoring
supplier sites regularly toring data regularly
view relevant manufacturing and pro- Among other issues respondents cited:
cess monitoring data regularly; and
20% have set up dashboards to moni- •A
lot of manufacturing and qual-
tor KPIs for contract partners. ity data for CMOs can only be seen
during on-site visits
When asked to define their biggest
challenges in managing CMOs, most •C
MOs need to prevent process
respondents (30%) cited knowledge drift and poor decisions by man-
transfer; 24%, process validation; and agement
an equal number, change control.
In addition, 23% said that risk man- • Insufficient knowledge of CMC issues
agement was their top challenge;
21% reported monitoring; 15%, CAPA •W
rote one respondent, “It can be
coordination; and 14% tech trans- difficult to ask informational ques-
fer. “Someone always seems to be tions from most of our suppliers.
asleep at the switch,” wrote one. An- They are reluctant to provide help-
other described high attrition rates at ful information for fear of incrimi-
smaller CMOs, with poor knowledge nating their own products.”
transfer the result.
Other respondents noted that, given
“If you don’t have a quality and tech- limited internal resources, it was be-
nical rep on site for each batch pro- coming more difficult to maintain close
duced at a CMO, there are items that and meaningful contact with suppliers.
don’t get documented at the same Said another, “review of documenta-
time, so resulting deviations aren’t al- tion alone does not provide a full pic-
ways documented efficiently.” ture of actual performance.”
Excerpted from Chapter 9 (pp 201-206), with the permission of J Wiley & Sons
2. T
he company believes that the
core competencies required could
be carried out more effectively by
an experienced third party. This is
typically called a make vs. buy de-
cision.
(877) 536-1538 or
www.fedequip.com
4 Risk management
Proactive risk assessment to predict potential risks and apply
appropriate risk management and mitigation techniques.
SOURCE: McKinsey
5 Supplier development
Processes for ongoing performance management and contin-
uous improvement of supplier capabilities.
with the right organization structure, tive supplier quality specialists have
the right ‘local’ presence (e.g., at a a combination of deep technical and
supplier site or in the supplier’s re- quality expertise and strong busi-
gion) and smart performance man- ness acumen in order to effectively
agement and incentives. Companies drive change in their suppliers’ oper-
need to move away from an over- ations and management practices.
emphasis on purchased cost and en-
sure that a holistic view of supplier Supplier quality management
performance is part of the agenda approach in action
for their COO or CPO. One large medical device company
applied many of the techniques out-
•S
upplier quality mindsets & capa- lined above to uncover and rectify
bilities: Focused communication ef- many of their supplier quality issues.
forts with suppliers are required to Along with organizational changes,
maintain attention on quality issues. the company followed a three-
But it is equally important to invest phased approach to improve supplier
in getting the right people with the quality performance.
right skills and expertise. Supplier
quality results are strongly corre- • Diagnostic phase: First, the com-
lated with the competence level of pany identified the sources of sup-
the organization. The most effec- plier quality risk by conducting a full
http://www.fedequip.com
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Current Deals & Liquidations
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FDA Quality Management System Guidance
http://www.fda.gov/downloads/Drugs/.../Guidances/UCM070337.pdf CLICK HERE
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