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 :
- 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
- 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.
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control.engineering
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
|Product :||Review period :|
|Content Uniformity||Impurity Profile||
Annexure – 2
Specimen format of “Evaluation of Inprocess Analytical data ”
|ANNUAL REVIEW OF DRUG PRODUCT’S QUALITY
EVALUATION OF INPROCESS ANALYTICAL DATA
|Product :||Review Period :|
Specimen format of “Evaluation of Yield data”
|ANNEXURE – 3|
|ANNUAL REVIEW OF DRUG PRODUCT QUALITY
|Review Period : From: To:|
|% of Theoritical Yield|
Annexure – 4
Specimen format of “Batch data”
|ANNEXURE – 4|
|ANNUAL REVIEW OF DRUG PRODUCT QUALITY
EVALUATION OF BATCH DATA
|Reveiw Period : From : To :|
|No.of Batches Manufactured:|
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