About Us
Excellence Through Stewardship is the first industry-coordinated undertaking to meet today's product stewardship challenges and to provide a strong quality management program (QMP) for the full life cycle of biotech plants into the future. The program is intended to promote the responsible use of agricultural biotechnology, the continued global adoption of plant biotechnology and the enhanced value of biotech-derived plant products in the marketplace.
This new stewardship program continues the Biotechnology Industry Organization's (BIO's) efforts to promote consistently high quality standards across the agricultural biotechnology industry for product stewardship and quality management issues. Many companies already have quality management programs in place. The Excellence Through Stewardship program takes these programs to the next level by providing industry guidelines for the adoption of stewardship principles and third-party audits of quality management practices.
The Excellence Through Stewardship program is comprised of three major components:
- Stewardship Objectives, Principles and Management Practices
- Guide to Understanding and Implementing a Quality Management Program for Maintaining Plant Product Integrity (QMP Guide)
- Stewardship Audit Program
As a global stewardship program, Excellence Through Stewardship will be introduced in a three-phased approach. The biotech industry anticipates that the program will be rolled out in the United States over the next 18 months, and will subsequently be extended globally within three years.
Stewardship Objectives, Principles and Management Practices
The Excellence Through Stewardship program is intended to help companies achieve compliance with applicable regulatory requirements, plant product integrity, the flow of goods in commerce and the prevention of trade disruptions. Through the use of documented quality management programs, Excellence Through Stewardship encourages the implementation of stewardship programs during all phases of the product life cycle, including product integrity, conducting of field trials, product launch, incident response and product discontinuation.
QMP Guide
BIO is developing a QMP Guide, which provides detailed guidance on how to develop and implement an appropriate quality management system (from discovery through commercialization and post-market activities). While the QMP Guide is in a ready-to-use format, which makes it easy to adapt to specific activities and operations, it is a flexible program that companies can adapt to their own quality management practices and standard operating procedures.
Stewardship Audit Program
The Excellence Through Stewardship program calls for third-party audits of stewardship and quality management systems for all phases of the product life cycle. Independent third-party audits are designed to verify implementation of each company's stewardship and quality management systems to confirm that the systems comply with the Excellence Through Stewardship program.
Certified auditors will have participated in BIO training, or otherwise meet specific criteria, to help provide independence, accuracy and fairness. Audit focus areas include:
- Management support and commitment
- Measurable quality objectives and standards
- Resource planning focusing on product integrity
- Effective training and competency assessment practices
- Document control systems
- Material control and identification practices
- Compliance and verification practices
- Mechanism for continuous program improvements
- Clearly defined stewardship process
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