NEW YORK, May 25 (GenomeWeb News) - Microarray service provider Expression Analysis said today that it has met all requirements for compliance with the Food and Drug Administration's good laboratory practice regulations.
The company said it took two years to develop and implement standard operating procedures, equipment and process validations, training, internal audits, and document control measures to meet the FDA's 21 CFR Part 58 guidelines for nonclinical laboratory studies.
According to Expression Analysis, it is now "the first company capable of providing Affymetrix GeneChip processes performed in compliance with GLP regulations."
Expression Analysis has already collaborated with the FDA as part of the agency's effort to standardize microarray data used in regulatory submissions. Steve McPhail, Expression Analysis' CEO, said in a statement that GLP compliance was "a logical next step" for the Durham, NC-based firm.