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APR Objectives
Objective Determine appropriateness, or need to change, product specifications Same as above for starting materials Need to change manufacturing procedures Same as above for in-process controls Verify consistency of existing process Need for re-validation of processes Highlight trends Identify product / process improvements Identify corrective actions Consider previous reviews Grouping of products FDA 211.180(e) Required Not specified Required Required Not specified Not specified Expected Not specified Expected Expected Not allowed EU/PIC/s Required Required Not specified Not specified Required Required Required Required Required Required Allowed
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Example Objectives
1. Determine the need to make changes to manufacturing processes, process controls, in-process tests or product specifications 2. Verify compliance with marketing authorisations 3. Verify the consistency of manufacturing processes 4. Determine the need for re-validation of existing processes 5. Identify product or process improvements 6. Identify any adverse trends and the need to take corrective and preventive action 7. Determine the appropriateness of starting material and product specifications.
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APR
1. Scope and Objectives 2. Responsibilities for Reviews 3. Product Grouping Strategy 4. Product Related Reviews 5. Modular (non-product specific) Reviews 6. APR Summary Reports and Conclusions 7. Risk Assessment and Re-validation Programs
The APR should also include a comparison to the previous year(s) review report, to assess year to year consistency
Responsibilities
Team Based Reviews share the load ! Head of Quality: overall co-ordination, review scheduling and management:
Ensuring that the APR is completed on time. Overseeing the applicable processes listed in the SOP Organising contract manufacturing partners. Ensuring investigations when adverse trends observed. Reviewing and approving the APR Summary Report: raising a change record and agreeing the recommended changes. Ensuring commitments for changes and improvements are tracked and completed through the CAPA record.
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Production and QA
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APR Subsection/Element Reports that contain or reference all of the data and documented analysis for each element. Annual Product Review Summary that contains an integrated analysis of all the APR Subsection/Element Reports and the overall APR rating. Reference list of all CAPAs raised as result of the APR summary
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Analysis Product R
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