Key Tenents

When using a Plant Breeding Innovation (PBI), like genome editing, to develop new plant products it is important to have applicable management components in place designed to address quality, consistency, and integrity throughout the product lifecycle. A basic set of quality considerations helps coordinate and direct an organization’s activities by establishing routine and consistent output based on the implementation of internal processes. The activities outlined below are based on proven quality management principles that are applicable to any size or type of organization producing plant products.

 

A. Quality Management/Product Integrity

While approaches may vary for tracking, recordkeeping, and testing of material, key aspects of an effective quality management system (QMS) are summarized below: 

 

• Standard operating procedures (SOPs)

• Document management processes

• Properly trained personnel

• Practices to ensure plant product integrity is maintained

• Internal verification practices

• Practices for managing and correcting nonconformities  

 

This section provides guidance for the development and implementation of a QMS to maintain plant product integrity and support research, development, and commercial activities for plant products developed using PBIs. This includes plant products where PBI may only be used as a breeding tool/intermediary or activities where the intent is to develop and commercialize a product. The QMS should be designed and influenced by the organization’s objectives, operations, and products.

 

As part of their QMS, organizations must consider the design and implementation of systems and processes for maintaining plant product integrity including product identity and purity for relevant activities. For purposes of this program, plant product integrity means establishing and maintaining the specific identity of a plant/seed product and the purity of that product using appropriate quality management measures.

 

Requirements for QMS Implementation:

• Develop, define, and regularly evaluate your QMS as appropriate: Plan so that quality objectives are communicated throughout the organization, and monitored by management.

• Training: Develop training practices and provide the necessary training so that personnel have the required competencies to perform the activities to reach quality objectives.  Develop and implement measures to assess the efficacy of the training and improve as needed.

• Documentation: Determine and develop the needed documentation to enable the effective operation of the QMS. An effective QMS contains documented information that is relevant, readable, and version controlled to maintain integrity and consistency.  All QMS documents should be reviewed on a regular basis to ensure they are reflective of current practices and methods.

• Control and Measure: Regularly audit quality processes to assess effectiveness and conformance to requirements. Nonconformities are identified, corrected, and measures are implemented to prevent future reoccurrence.

• Review and Improve: Regularly evaluate the performance of the QMS; utilize resources such as employee feedback, process reviews, risk/opportunity reviews, and management team reviews. Clearly communicate the results of these reviews to appropriate personnel so improvement ideas can be implemented and executed.

 

 

B. Product Characterization[1]

All new plant products, regardless of how the specific combination of plant characteristics was achieved (i.e., what breeding methods and practices were used), will typically undergo several years of product selection and testing under geographically diverse, commercially relevant field/production conditions to confirm that the lines identified for commercial release will perform as expected. Well-designed, experience-based breeding and selection protocols deliver products with desired characteristics and help minimize the possibility of off-types or other undesirable characteristics.

 

Methods for targeted introduction of genetic variability (such as genome editing[2]) increase the specificity and efficiency of breeding by reducing the time and efforts needed to obtain desirable characteristics. There are different genome editing methods and this section is intended to apply across a wide range of the methods used to develop new plant products.

 

Guidance for Product Characterization:

Appropriate protocols should be in place for the following aspects at relevant stages of the product life cycle:

• Processes to ensure plant identity.

• Design criteria for genome editing components; (e.g. choice of the target and guide RNA design) to minimize the potential for unintended off-types or undesirable characteristics.

• Processes to verify/determine absence of vector-derived sequences if edits are generated using a vector-based delivery of editing components.

• Processes to confirm and describe the targeted DNA change(s) that were made.

• As with conventional breeding practices breeders select for plants with desired characteristics.

 

 

[1] For additional information please refer to ASTA’s Guide: Evaluation of Genome Edited Plants that has also been adopted by the ISF.

[2] Genome editing (also called gene editing) is a group of technologies that give scientists the ability to change an organism's DNA. These technologies allow genetic material to be added, removed, or altered in a site-specific manner in the genome.