annualreview产品质量年度的度回顾英文版模板.docVIP

XXXXXXXX XXXXXXXX Quality SOP Annual Reviews SOP No.: M-050 Effective: Supersedes: Page PAGE 2 of 2 DBC: 6.17 Quality SOP Quality SOP Annual Reviews SOP No.: M-050 Effective: Supersedes: Page PAGE 1 of 2 DBC: 6.17 Principal Author Principal Author Approver/Date Approver/Date Approver/Date PURPOSE: To perform the annual review of 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. 2.0 SCOPE: All Customer complaints, recalls, returned or salvaged drug products, notification of rejection forms, out of specification result forms, critical system change control forms, investigation/deviation reports that occurred throughout the year will be reviewed on an annual basis. Applies to all products and the documents pertaining to their manufacture. 3.0 RESPONSIBILITY: 3.1 It is the responsibility of the Quality Control/Stability Systems Technician to prepare a separate annual report on each product that is marketed by Company. 3.2 The Quality Assurance Assistant Scientist and/or the QA Manager is responsible for reviewing the documentation from selected batches of every product. 3.3 The QA/QC Director and/or the QA Manager and/or QC Manager are responsible for: 3.3.1 Reviewing each products annual report. Perform review of recalls, returned or salvaged drug products, notification of rejection forms, out of specification result forms, critical system change control forms, investigation/deviation report forms. The Regulatory Affairs Paralegal is responsible for providing a summary annual review report of all complaints by product. The Regulatory Affairs Director is responsible for reviewing the summary annual complaint report. 3.6 The QA/QC Director is responsible for notifying the responsible officials of the company in writing if an investig