ICH stability conditions application to marketed products could lead to compliance problems -- ex-Roche exec.
ICH STABILITY STANDARDS MAY POSE PROBLEMS FOR MARKETED PRODUCTS, ex-ROCHE Quality Control/Quality Assurance Director and industry consultant Judy Boehlert said at a Feb. 13 FDA training session on International Conference on Harmonization guidelines held in conjunction with industry and the University of Maryland-College Park. The training program reviewed seven quality guidelines covering stability (Q1A, Q1B, Q1C), impurities (Q3A, Q3B), and validation of analytical procedures (Q2A, Q2B).
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