HOT POST

50/recent/ticker-posts

Header Ads Widget

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 Company Name. 

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; 

      - 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



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 below link

Attachment - III

PEOPLE ALSO READ: SOP for Data Integrity

Post a Comment

0 Comments

close