美国FDA原料药查厂重点经验分享.ppt

Confidential 美國FDA原料藥查廠重點經驗分享 Processes Covered During API Inspections Abroad ICH Quality Topics Checklist Six Systems QUALITY SYSTEM(FDA Compliance Reference Program Guidance) Evaluation of whether The Quality Unit (QA) is reviewing and approving all SOPs related to production, QC, and QA. Seek assurance that the SOPs are adequate for their intended use. This also includes a review of the associated record keeping as well. QUALITY SYSTEM(FDA Compliance Reference Program Guidance) The FDA considers the following SOPs to be critical and will want to review them to see if they are written, and if they are being followed as written where there use is required. Annual Product review Complaint Reviews Discrepancy and Failure Investigations related to both the manufacturing and testing. “ documented, evaluated, investigated in a timely manner; includes corrective action where appropriate.” QUALITY SYSTEM(FDA Compliance Reference Program Guidance) Change Control: “documented; evaluated; approved; and need for revalidation assessed.” Validation: status of required validation/ revalidation for computer uses, manufacturing process, and laboratory methods. Training/qualifications of employees in the quality (QA) unit. QUALITY SYSTEM(FDA Compliance Reference Program Guidance) SOPs for: Review and approval by QA of all production and process control procedures and all laboratory control mechanisms, specifications, standards, sampling plans, test procedures. Adequate review and approval by QA of production and control records for each batch before release and distribution. Adequate annual product review procedure and for reviews being performed including OOS and DIR reviews. QUALITY SYSTEM(Change Control Procedure) FACILITIES AND EQUIPMENT SYSTEMS(FDA Compliance Reference Program Guidance) Description and layout of any specialized air-handling systems including IQ/OQ and records of maintenance and filter changes if applicable. IQ/OQ for all major manufacturing equ