GXP

Compliance Case Study #17: Spots On Tablets – An Investigation

Equipment Cleaning and Visual Evaluation, Journal of GXP Compliance (JGXP), V13, #1, Winter, 2009. Questionable Equipment Qualification, JGXP, V14, #1, Winter, 2010. Manual Processes – Performance, Responsibilities, and Training, JGXP, V14, #1, Winter, 2010. Cleaning Validation Unknown HPLC Peaks, JGXP, V14, #1, Winter, 2010. Secondary Packages with Defective Glue Joints, JGXP, V14, #2, Spring, 2010. Identical Mixing Tanks, JGXP, V14, #3, Summer, 2010. Broken Punches, JGXP, V14, #3, Summer, 2010. White Spots on Tablets, JGXP, V14, #4, Autumn, 2010. Substandard Data and Documentation Practices,...

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