Annual Product Review (APR)
The term APR most commonly heard in the pharma field but the people working in other departments not have much idea on this why because typically this can be done by Quality Assurance team.
Before going to explore the information about APR we should know the definition. Definition of Annual Product Review (APR): Annual product review is an Evaluation conducted Annually to access the quality standard of each product and also to verify the consistency of each drug manufacturing process. Why APR is required in drug manufacturing units?
I must say to determine the changes needed in drug process specifications or control procedures. This APR is used to determine the trend in order to improve the controlled procedures leads to revalidation. Retention Period in QA: Product Expiry + 1 Year = 6 Year Retention Period
This Annual Product Review and filing mostly annoying due to deep dive into the data review process but by developing automation methods in the manufacturing units will give automatic accurate reports surprisingly few MES systems integrated to file and generate the automatic APR reports through accessing the data. Lets look into the sequence of steps involving in this review.
Select the Product
Plan the review schedule
Content of APR
Review of materials used in the manufacturing and packing process.
Detailed description of any new source of raw and packaging materials.
Summary of deviations or rejections of batches.
Review of critical manufacturing process parameters.
Finished Product Analysis.
Review of yield.
Review of change controls.
Out of Specification test results analysis.
Review of complaints
Review of stability studies
Reprocessing/Reworkings of the product.
Review of return goods
Product recalls
Review of rejected batches
Review of validation batches Using control charts data should be interpreted and evaluated by the trends which gives you the summary and recommendations on the product states process is in control or not.
Before going to explore the information about APR we should know the definition. Definition of Annual Product Review (APR): Annual product review is an Evaluation conducted Annually to access the quality standard of each product and also to verify the consistency of each drug manufacturing process. Why APR is required in drug manufacturing units?
I must say to determine the changes needed in drug process specifications or control procedures. This APR is used to determine the trend in order to improve the controlled procedures leads to revalidation. Retention Period in QA: Product Expiry + 1 Year = 6 Year Retention Period
This Annual Product Review and filing mostly annoying due to deep dive into the data review process but by developing automation methods in the manufacturing units will give automatic accurate reports surprisingly few MES systems integrated to file and generate the automatic APR reports through accessing the data. Lets look into the sequence of steps involving in this review.
Select the Product
Plan the review schedule
Content of APR
Review of materials used in the manufacturing and packing process.
Detailed description of any new source of raw and packaging materials.
Summary of deviations or rejections of batches.
Review of critical manufacturing process parameters.
Finished Product Analysis.
Review of yield.
Review of change controls.
Out of Specification test results analysis.
Review of complaints
Review of stability studies
Reprocessing/Reworkings of the product.
Review of return goods
Product recalls
Review of rejected batches
Review of validation batches Using control charts data should be interpreted and evaluated by the trends which gives you the summary and recommendations on the product states process is in control or not.
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