SOP on Annual Product Review of Drug Product Quality

SOP on Annual Product Review of Drug Product Quality

  • 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 for distribution and apprise upper management of any changes needed.
  • RESPONSIBILITY :
  • Officer – Quality Assurance to compile the data for Annual Review and to prepare the annual review report
  • Head – Quality Assurance Department to approve the Annual Review Report and to  ensure compliance
  • PROCEDURE :
  • All batches shall be included in the evaluation. Batches in which manufacturing processes were changed during the year shall be evaluated separately.
  • 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 following analytical results shall be evaluated for all batches :  
  • Finished Product analytical data :
  • Assay.
  • Content Uniformity (high, low, average and relative standard deviation)
  • Dissolution rate (high, low, average)
  • Impurity Profile ( % of maximum individual impurity and % of total impurities)
  • Record the above details in format ” Evaluation of Finished Product Analytical data”(Annexure -1)
  • Inprocess Analytical data:
  • Blend Assay.
  • Average weight (Low, high and average)
  • Weight variation (Low, high , average and RSD)
  • Physical parameters where applicable such as thickness (low, high, average and RSD), Hardness (low, high, average and RSD).
  • Record the above details in ‘ Evaluation of In -Process Analytical data ‘ – Annexure – 2
  • Yield:
  • 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 in ‘Evaluation of  yield data’ (annexure – 3)
  • Prepare statistical graphs  for analytical data and yield  wherever applicable.
  • Current values  obtained and previous year values shall be compared to determine the variation in patterns that could indicate tendencies or changes in process.
  • 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 heads for investigation.
  • All the individual results shall be within the approved specifications.
  • General Data:
  • The annual Quality review report shall also include the following :
  • Stability data of batches which are kept on stability.
  • The reserve sample inspection reports wherever applicable.
  • Investigation reports of market complaints and product recalls.
  • Summary of deviations and non-conforming events.
  • Water   system   evaluation : The  purified water  USP system  shall  be evaluated in a  yearly basis. The evaluation shall be performed  by evaluating microbiological  and  chemical  data  compiled.  The  report  shall   include changes that occurred during the year.
  • The Annual Product Review Report  shall be approved by Head – Quality Assurance .
  • Head – Quality Assurance shall forward the summary of the behaviour of  the product during the review period to Head -Production, Head – R&D, Head -QC and Division Head.
  • The data shall be presented as follows :
  • Section 1 (Cover sheet )
  • Product name,  Product code, and ANDA numbers.
  • Section 2
  • Manufacturing history to include:
  • Batch number, Batch size, Expiry date, packaging type and units per pack, total number of batches, released or  rejected or underhold. Compile the information in the format “Evaluation of batch data”.   (Annexure -4)
  • Section 3 :
  • Trend analysis to include:
  • Assay, dissolution, content uniformity, weight variation, average weight, hardness, thickness, yields, analysis.
  • Section 4
  • Exceptions to include:
  • Investigation reports of deviations and non conforming events, OOS results from laboratory and production.
  • Section 5
  • Stability to include:
  • A summary of the stability data and  analysis of problems or possible problems.
  • Section 6
  • Complaints to include:
  • A summary of market complaints, both medical and quality.
  • Section 7
  • Recalls, field alerts,  and field corrections.
  • Forms and Records (Annexures)
  • Specimen format of “Evaluation of Finished Product Analytical Data” – Annexure – 1
  • Specimen format of “Evaluation of Inprocess Analytical  data ” – Annexure – 2
  • Specimen format of “Evaluation of Yield data” – Annexure- 3.
  • Specimen format of “Batch data” – Annexure – 4.
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control.engineering
  • History
    Date Revision Number Reason for Revision
    00 New SOP

Annexure – 1

Specimen format of “Evaluation of Finished Product Analytical Data” 

ANNUAL REVIEW OF DRUG PRODUCT QUALITY

 EVALUATION OF  FINISHED PRODUCT ANALYTICAL DATA

QUALITY ASSURANCE
Product : Review period :
Batch No.

 

Assay

 

 

 

Dissolution

 

Content Uniformity      Impurity Profile  

Others

(specify)

 

Low

 

 

High

 

 

Stage Low

 

 

High

 

 

Average

 

 

RSD

 

 

Total

impurities

 

Maximum

Individual

impurity

 

 

 

 

Annexure – 2

Specimen format of “Evaluation of Inprocess Analytical  data ” 

ANNUAL REVIEW OF DRUG PRODUCT’S QUALITY

EVALUATION OF INPROCESS ANALYTICAL DATA

QUALITY ASSURANCE
Product : Review Period :
S No

 

Batch

No.

Blend

assay

Average weight

 

Weight variation

 

Hardness

 

Disintegration

 

Thickness

 

%Weight build-up
High low average High low average High Low Average High Low Average High Low Average during coating

Annexure- 3.

Specimen format of “Evaluation of Yield data”

ANNEXURE – 3
ANNUAL REVIEW OF DRUG PRODUCT QUALITY

YIELD DATA

 Product:
Review Period :            From:                       To:
S.No.

 

 

Batch No.

 

 

Batch Size

 

 

        % of Theoritical Yield
Blend

 

Core tablets/

Filled capsules

Coated

tablets

Packed

Product

Total Batch

 

Annexure – 4 

 Specimen format of “Batch data”

ANNEXURE – 4
ANNUAL REVIEW OF DRUG PRODUCT QUALITY

EVALUATION OF BATCH DATA

Product Name:
Reveiw Period :   From :                     To :
No.of Batches Manufactured:
Batch No.

 

Batch Size

 

Expiry date

 

Packaging Batch Status
Type Units/Pack Released Underhold Rejected

 

For More Pharma Updates Visit –https://pharmaguidances.com

 

error: Content is protected !!