ANNUAL PRODUCT REVIEW

In this slide contains definition, importance, benefits of annual product review.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).
RIPER, anantapur.

1. ANNUAL PRODUCT REVIEW Presented by Ravi Shankar babu .D.V . (20L81S0403) I-M pharmacy Quality Assurance Subject-Quality Management System Under the guidance of Dr. Nawaz M.Pharm , Ph. D. Associate Professor of Pharmaceutical Quality Assurance

2. 2 Definition Importance of APR Basic contents of APR Why do APR required Benefits Analytical and Inspection data FDA inspections Contents

3. 3 Evaluations conducted anually to verify the quality standard of drug product and consistency of the process To implement any changes if required Importance of APR : To verify the consistency of the process To detect the product quality and process defects To eiew qualiyt of raw materials and packaging material use for the product Definition :

4. 4 To detect process quality Basic contents of APR: To review -raw material and packaging material -change control process -results of stability monitoring programme and adverse events -product returns -qualification status of relevant equipment

5. 5 For the review of - returns and recalls - investigations - every batch Benefits: Can assess the required changes in -product specification -manufacturing/control procedures To detect product improvement & opportunity of cost reduction Provides a preparation tool for FDA inspection Why APR required

6. 6 They use to complie percentage yield at all stages FDA Inspections : They develop a standard/comprehensive SOP Follow up SOP If fails to follow receives concerns from investigators Review of yield:

7. 7 That include all required elements into APR Identify and implement corrective/improvement actions Assures that quality unit reviews (QA) &approves the APR

8. 8 Summary: For obtaining the better results regarding our prepared product (stability studies) and also to detect any change control of our process (consistency of process), APR is suitable in such a way that quality of products that had been manufactured during a year can be determined in a statistical way.

9. 9 Reference: Pharmaguideline , “Importance of Annual Product Quality Review”, http://www.pharmaguideline.com/2013/11/importanc e-of-annual-product-quality-review-apqr-aprpqr.html (Last accessed on 8/1/2015) Health Sciences Authority, “Guidance notes on Product Quality Review”, January 2013, http://www.hsa.gov.sg/content/dam/HSA/HPRG/Ma nufacturing -Importation-Distribution/Overview-Framework-Policies/GUIDE-MQA-024-004.pdf. [accessed on 8 January 2015] PharmaManufacturing.com, “Annual Product Reviews: How to Conduct an Effective Annual Product Quality Review”, February 2012, http://www.pharmamanufacturing.com/articles/2012/ 018/ (Last accessed on 9/1/2015)

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