SOP for Annual Product Review (APR)

OBJECTIVE 

To establish a procedure for the preparation, review, and approval of Annual product reviews to assure the consistent and acceptable quality of each product manufactured. 

SCOPE 

This SOP is applicable to annual product review of all finished product manufactured in a year at Pharmasky Ltd. 

RESPONSIBILITY 

QC Executive is responsible for maintaining trend analysis report. 
QC Manager shall be responsible for preparation of final annual report. 
QA Manager shall be accountable for implementation of this SOP. 

PROCEDURE 

• Annual product review will be prepared only for commercial batches. 
• The calendar year shall be from January to December. The final Annual Review Report shall be available with in sixty (60) days after the end of calendar year. 
• The analytical results shall be evaluated for all batches. 
• Record the details in Attachment-1 for Physical parameters, Dissolution and Assay. 
• For each batch compile the % theoretical yield obtained at critical stages like blending, compression / filling, coating, packaging etc.., and % of theoretical yield of the batch record in Attachment-II. 
• Calculate the analysis of variance (ANOVA) for minimum of ten batches in Attachment-1. 
• Prepare statistical graphs for analytical data and yield wherever applicable.  
• Values obtained should not differ significantly from previous year values. If a significant difference or an abnormal pattern is observed inform to the Production and R&D for investigation. 
• All the individual results shall be within the approved specifications. 
• Prepare the annual product review report as per Attachment-III. 
• Collect the following information for preparation of Annual Product Review; 

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      - Product Name 

      - Composition and Changes, if any 

      - Number of batches manufactured 

      - Quantity of finished products manufactured 

      - Quantity of Finished products released 

      - Any changes in manufacturing/packing/filling 

      - Any major modification of machines 

      - Any modification in area/environment 

      - Trends of analytical parameters 

      - Any deviation in analytical method 

      - Any OOS in laboratory results 

      - Brief summary of complaints 

      - Summary of stability results if any 

      - Any changes in packaging components 

      - Percentage yield of all batches with an average (finished product) 

      - Quantity of market returns, reprocessed & rejected 

ABBREVIATIONS 

SOP – Standard Operating Procedure 

QC – Quality Control 

QA – Quality Assurance 

ANOVA - Analysis of Variance 

ATTACHMENTS 

Attachments I: Annual Review of Drug Product Quality Annual Trend Report 

Attachments II: Annual Review of Drug Product Quality (Yield Data) 

Attachments III: Annual Product Review Report

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Attachment-I --- ANNUAL REVIEW OF DRUG PRODUCT QUALITY

Assay Results

Batch No.	Assay		Batch No.	Assay
						Min. :
						Max. :
						Average:
						SD:
						% RSD:
						Prepared By:
						Checked By:
						Limit:

Dissolution Results

Batch No.	Dissolution		Batch No.	Dissolution
					Min. :
					Max. :
					Average:
					SD:
					% RSD:
					Prepared By:
					Checked By:
					Limit:

Physical Parameters

Batch No.	Average Weight	Weight Variation		Hardness	Thickness	Friability	Disintegration
		+	-

Attachment-II --- ANNUAL REVIEW OF DRUG PRODUCT QUALITY (YIELD DATA)

Sr. No.	Batch No.	Batch Size (kg)	% of Theoretical Yield
			Blend	Tablet		Packed Product
				Core	Coated
1
2
3
4
5
6
7
8
9
10

Attachments III: Annual Product Review Report

Download from the below link

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