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Case Studies


 

 

Pfizer uses a guideline for contract manufacturing and research to monitor its outsourcing providers, thus helping to assure its revenue stream, guard against liabilities, and protect its brands.

 

 

 

"Pfizer EHS Colleagues are full partners in evaluating the suitability and performance capabilities of our contract manufacturers. Their contribution to the management of supplier relationships is required and essential to the overall success of our program."

Tom Lawlor
Senior Director, Global Contract Manufacturing
Pfizer Inc.

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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