Common Deficiencies Observed by Various Regulatory Agencies
Abstract
Siddhi Shah, Dr. Jignesh Shah*
More than 50% of the total number of deficiencies related to the manufacturing sections of the Common Technical Document (CTD). Deficiencies related to API, Management of quality, Investigation of deviations, Corrective and preventive actions, Potential for contamination, Supplier and Contractor Audits, Design and Maintenance of equipment, Data integrity issues, Data manipulation, Manufacturing controls, etc., The number and pattern of deficiencies did not change over time. The most frequent critical deficiencies were related to the specific manufacturing process and the key materials used in particular the API starting materials, impact of the API impurity content.
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