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Number of product manufacturing facilities site inspections which occurred during the month

Dictionary: Number of OBP product manufacturing facilities site inspections which occurred during the month. OBP review staff participates in most pre-approval inspections and many surveillance inspections of manufacturing facilities. For complex products, such as therapeutic protein and monoclonal antibody products, it is important for OBP reviewers to participate in the assessment of the manufacturing process and controls at the facility.

These measures have been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

• FY 2010
• FY 2011
• FY 2012
• All

Number of pre-, post-, and during inspection meetings which occurred during the month

Dictionary: Number of pre-, post-, and during inspection meetings with ORA and CDER’s Office of Compliance (OC) Division of Manufacturing and Product Quality (DMPQ) which occurred during the month. For complex products, such as therapeutic protein and monoclonal antibody products, it is important for OBP reviewers to participate in the assessment of the manufacturing process and controls at the facility. This participation involves meetings. In addition, for facilities where OBP does not participate in the inspection, meetings convey issues to be considered during inspections.