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Pfizer Standard for Contract
Manufacturing and Research |
Pfizer, the world's largest pharmaceutical company,
outsources a portion of its manufacturing and research
activities, including active pharmaceutical ingredients, drug
products, and packaging. To assure its revenue stream, guard
against liabilities, and protect its brands, Pfizer emphasizes
close monitoring of its Contract Manufacturers and Researchers
(CMRs).
Since the mid-1990's, Pfizer has had a company standard for
managing its worldwide outsourcing partners, and since 1998
has systematically conducted EHS reviews of these partners to
assure that they are managing the EHS aspects of their
business. The experience gained from over one hundred on-site
reviews has been codified into a new internal performance
standard, released in 2001. Its objective is to safeguard
against undesirable consequences resulting from unacceptable
EHS performance at Pfizer's CMRs.
Pfizer's performance standard requires each operating group
to:
- Determine whether a new CMR is acceptable before
deciding to use it.
- Assure that CMRs receive all relevant EHS information on
its proprietary compounds and technology and update it as
warranted to assure they can manage EHS risks effectively.
- Devote resources to conducting periodic EHS reviews of
all CMRs.
- Develop and implement a management system for EHS
relationships with CMRs.
CMR reviews are conducted by the operating group EHS Staff,
collaborating with facility and in-country colleagues. Issues
covered as part of these reviews include:
- Adequacy of permits to operate
- Site conditions that may reflect environmental
sensitivity
- Emissions and waste management and pollution prevention
capabilities
- Occupational health and safety procedures, including
process safety
- Financial resources for EHS management
- Existing or potential EHS-related liabilities
- Regulatory compliance status, including violations.
These EHS reviews are conducted before contract
manufacturing begins and at least once every four years
thereafter. Review results fall into three categories -
approved, approved with qualifications, or not approved. If
not approved, the contract manufacturer is not used. If
approved with qualifications, Pfizer follows up to assure key
action items are completed.
In addition to addressing fundamental EHS requirements,
Pfizer's on-site visits to CMRs often result in constructive
suggestions regarding advanced EHS practices and opportunities
for improving their cost-effectiveness. In India, for example, Pfizer collaborated with 3M and a local consultant to conduct
a training workshop for Contract Manufacturers on the subject
of workplace hazards.
Rather than merely policing its business partners, Pfizer
hopes to stimulate EHS performance improvement. Recently,
Pfizer has joined with several other companies,
the U.S. EPA, and the National Institute of Standards and
Technology to form a pharmaceutical industry Green Suppliers Network. This
collaborative venture plans to work with all levels of the
manufacturing supply chain to achieve environmental and
economic benefits, including improved products and processes,
increased energy efficiency, cost savings, and waste
elimination.
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