The document discusses the Annual Product Review (APR) process in pharmaceutical quality assurance, highlighting its definition, importance, basic contents, and benefits. APRs are essential for verifying drug product quality, detecting defects, and ensuring consistency in manufacturing processes. The summary suggests that conducting an APR can lead to improved product specifications, cost reductions, and better preparation for FDA inspections.

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