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. Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
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. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2
Definition
Importance of APR
Basic contents of APR
Why do APR required
Benefits
Analytical and Inspection data
FDA inspections
Contents

3. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 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. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 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. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 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. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 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. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7
That include all required elements into APR
Identify and implement corrective/improvement actions
Assures that quality unit reviews (QA) &approves the APR

8. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 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. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 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)

10. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 10