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1.0 Introduction
2.0 Number of Intermediates and APIs batches produced
3.0 Review of output for all Isolated Intermediates and Finished Products
4.0 Review of Critical Quality attributes of In-process, Isolated Intermediates and Finished Products
5.0 Summary of changes made during the year with respect to equipment, Process, Specifications, and Methods, Raw materials and others.
6.0 List of Deviations and a brief description of deviations and action taken.
7.0 List of customer complaints; Return goods and Recalled goods along with description and actions taken
8.0 Number of Reprocessed and Reworks batches in all stages during the year2009
9.0 Review of Key starting materials and Primary packing materials and Rejections.
10.0 Review of Bio burden on product (for minimum of 3 batches)
11.0 Review on Stability studies and Summary
12.0 List of Out of specifications for Finished products
13.0 Review on Retained samples quality (Finished product)
14.0 Review on Validation packages (Process, Equipment, Procedure)
15.0 Status of Drug Master File (if any),Drug Master File new updates
16.0 Details of special training provided to employees in case of Deviations or Complaints received regarding a particular product
17.0 Summary Report
