34th SQA Annual Meeting and Quality College

F-1  EPA Regulatory Update 

F-2  Quality assurance auditing of analytical data in support of GMO crops development and production 

Abstract:
A genetically modified organism (GMO) has been produced by genetic engineering techniques.  Its genetic material has been altered to express one or more genes for novelty traits.  A common application of GMOs is in the agriculture and food industry where transgenic crops may offer selective advantages, such as resistance to insects or pathogens, herbicide tolerance, higher yields and increased nutritional values.  GMO testing laboratories develop and validate specific methods to fit the purpose of measuring certain new characteristics in diverse and complex plant matrices.  From a quality perspective, data should meet the well-known requirements of integrity, reproducibility, repeatability, accuracy, specificity, and traceability.  Quality assurance faces the new challenge to define and implement procedures to ensure that the measured analytical attributes are representative of specific transgenic events.  Compared to an environmental residue analysis, a typical auditing process for analytical GMO studies requires management of an increased amount of data complexity and variability.  Quality assurance auditing needs to verify that a standardized data interpretation is applied, so that the data produced is a consistent indicator of the genetic novelty.  A reliable quality system should include performance checks and indicators to guarantee that the overall GMO crop development and production process does meet current quality standards.  This presentation reviews the key aspects of auditing data measuring attributes in genetically modified crops and underlines how data quality translates into product quality.

Category:
Bioanalytical

Level of Content:
Advanced