APQR Annual product quality review

Please I need a template of Annual product quality review not sop or guidelines? Thanks . Our factory is dare in need of it. So that from it I can easily slot in our own data we generated. Thanks and thanks again

You can use any format to write observations of APPROVAL of the final products. Please consider following aspects while performing APQR,

  • Analytical results of the product as per specification
  • Details of any process deviations
  • OOS results and outcome of investigation
  • OOT observations
  • Details of market complaints related to that product
  • Details of Changes made in process, process parameters
  • Final product yields
  • Returned or recall of batches of that product
  • Stability studies outcome
  • Changes made in packaging materials
  • Process validation results, if any
  • Any other unusual observations
    Finally, a summary report of APQR should be written in brief to reflect entire APQR of that product.
    Please prepare tables to write the results, observations of all the batches manufactured in that year.
    Also prepare graphical presentation of all the Quality parameters for easy understanding the trend.
    Perform Trend Analysis.
    Based on the APQR summary, suggest the remedial actions, if required, such as Reformulation of the product or changestate in container, closure system or storage conditions with the help of Rs & D team.
    The summary of APQR report is then forwarded to the top management for their knowledge.

Dear Mr. Sunil,

If we found any below trends as sifting towards higher or lower side of any product/batch:

  1. physical parameters, Let-LOD, Hardness, thickness, ph, Visosity, density----What shall be done.
  2. Chemical analytical test results, Let Disso, assay, RS—What shall be done.
  3. Microbiological test results-------Let, Bioburden level, MLTWhat shall be done…

What action and recommendation shall be concluded?


reference guideline?

Thanks @sunilrbudhkar, I appreciate your response

These are all indications of out of trend situations and must be investigated thoroughly to know the root causes. It could be due to poor stabilit of product, a weak formulation or Inadequate packaging configuration used or manufacturing deviations.The matter needs to be referred to R & D formulations.

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