annual review Product quality annual review English templateXXXXXXXXXXXXX Principal Author ApproverDate ApproverDate ApproverDate Quality SOP Annual Reviews SOP No M-050 Effective Supersedes 11801 Pag

ting of any significant quality issues identified during the annual review. 4.0 PROCEDURE: 4.1 The Quality Control/Stability Systems Technician will prepare a separate annual report for each product that is marketed by the Company. The report will include a summary of all complaints, recalls, returned or salvaged drug products, notification of rejection forms, out of specification result forms, critical system change control forms, investigation/deviation report forms, product specifications, manufacturing and control procedures. 4.2 The Quality Assurance Assistant Scientist and/or the QA Manager will review the documentation from selected batches of each product to ensure compliance with product specifications, manufacturing and control procedures. 4.3 The QA/QC Director and/or the QA Manager and/or QC Manager will review each product's annual report and perform a review of all complaints, recalls, returned or salvaged drug products, notification of rejection forms, out of specification result forms, critical system change control forms, investigation/deviation report forms. 4.4 The Regulatory Affairs Paralegal will provide a summary annual review report of all complaints by product. 4.5 The Regulatory Affairs Director will review the summary annual complaint report. 4.6 The QA/QC Director will notify the responsible officials of the company in writing of any significant quality issues identified during the annual review. 5.0 REFERENCES: Quality SOP Annual Reviews SOP No.: M-050 Quality SOP Complaint Handling SOP No.: M-051 Quality SOP Stability Testing SOP No.: M-052 Quality SOP Deviations and Investigations SOP No.: M-053 Quality SOP Change Control SOP No.: M-054 Quality SOP Batch Record Review SOP No.: M-055 6.0 ATTACHMENTS: Non