Annual Product Quality Review (APQR) SOP

SOP for Annual Product Quality Review | APQR SOP in Pharmaceutical Industries |

  • APQR SOP covers below points:
    • Purpose of APQR
    • Selection of batches for APQR
    • Parameters to be included in the Annual Product Quality Review
    • APQR Format
  • To lay down a procedure for Annual Quality Product Review for the Products.
2.0 SCOPE :
  • This SOP is applicable to “Annual Product Quality Review” of the products, manufactured in each calendar year.
  • Q.A. officer and above
  • Q.A. Head

5.1 Product Quality Review is regular periodic reviews of all manufactured products, the review is conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product, investigation to highlight any trends and to identify product and process improvements.

5.2 Selection of batches for APQR

  • Check the number of batches manufactured in preceding calendar year. Take only those products for annual review whose minimum of 5 batches has been manufactured.
  • If product is having different brand names but generic name, strength, manufacturing procedure, formulation, primary packing, physical and chemical specifications is same then considers this as a one product.
  • Select the number of batches as per following criteria;
    • If 10 or less batches are manufactured take all batches for review,
    • If 10 to 20 batches are manufactured take alternate batch for review,
    • If 21 to 30 batches are manufactured take every 3rd batch for review,
    • If 31 to 40 batches are manufactured take every 4th batch for review and so on.

5.3 Include following in the Annual Product Quality Review:

  • Product details.
  • Recommendation made during previous product review period.
  • A review of yield of final (packed product) of all batches.
  • A review of critical in-process controls and finished product results:
    • Compilation(s) and review of in-process test results obtained from the total number of batches manufactured in that particular year, e.g., Average weight, Dissolution, Disintegration Time, Hardness, Friability, Assay etc. whichever is applicable for concerned product.
    • Compilation(s) and review of finished product test results such as Average weight, Dissolution, Assay whichever is applicable for concerned product.
  • A review of number of batches rejected and the reasons for the rejection and trend of last three years.
  • A review of all batches that failed to meet established specification(s) and their investigation trend of last three years.
    • Summary of the number of failed batches/products. The list will identify the batches that failed in specifications, (OOS) and the root cause for this failure, if identified.
  • Review of Batch Reworked, Recovered and Reprocessed:
    • Review of Batch reprocessing or reworking if done for any batch, or if any recovered batch is manufactured shall be included in product quality review
  • A review of all significant deviations or non-conformances, their related investigations, and the effectiveness of resultant corrective and preventive actions taken.
  • A review of all changes carried out to the facility, equipments, instruments, processes or analytical methods:
    • Summary of the changes, if any, made to the process, e.g., change of mixing time, process temperature, speed in compression / filling / primary packing etc.
    • Summary of the changes made to equipment like change in manufacturing equipment in process, change in any major change part etc.
    • Summary of the changes made to the analytical methods, e.g., change of solvents, buffers, reagents, pH, change in composition of mobile phase, change in HPLC method parameters, i.e., flow rate, temperature, wavelength, run time, and change of HPLC column etc.
    • Summary of the changes made to raw material / primary packing material vendor.
  • A review of the results of the stability monitoring programme and any adverse trends:
    • Summary of the number of batches included for stability studies during the review period and the reasons for their selection.
    • Summary of stability study report and results, i.e., out of specifications for each condition which might lead to product recall (Long term and accelerated studies), together with a review of the results obtained for stability indicating analytical tests shall be included in review.
  • Review of control samples for its physical defects during annual product quality (which might lead to product recall shall) be included in review.
  • A review of quality-related product returns, complaints and recalls and the investigations performed at the time:
    • Summary of batches returned due to potential quality defects, together with the reasons trend of last three years.
    • Summary of market complaints received in a year, together with the nature of complaints with trend of last three years.
    • Summary of market complaints in the respect of adverse reaction (if any) received in a year with trend of last three years.
    • Summary of batches recalled, together with the reasons with trend of last three years.
    • Compilation of investigation reports prepared following market complaints and the actions taken to prevent recurrence with trend of last three years.
  • If OOT results found during review (other than deviations), the same shall be evaluated as per Investigating and Handling of Out Of Trend (OOT) Test Results SOP
  • Annual product quality review shall be numbered as,
    • Where, QA  – Quality Assurance
    • APQR – Annual Product Quality Review
    • XXXX –  Product Name in abbreviated form
    • YYYY – Last four digit of current calendar year
  • Summary
  • Conclusion/comments
  • If the product quality review leads to the revalidation of the product/process the same shall be considered for revalidation with prior approval of QA Head.
  • The Annual Product Review shall have a conclusion statement which will clearly state whether the product under review consistently meets the quality standards, and if not, what actions need to be taken.
    • Follow up actions shall include the following :
      • Improvement in the product manufacturing process
      • Analytical method improvement
      • Review of product specifications
      • Revalidation
AbbreviationExpanded form
SOPStandard Operating Procedure
Q.A.Quality Assurance
Q.C.Quality Control
APQRAnnual Product Quality Review
HPLCHigh Performance Liquid Chromatography
OOTOut of Trend
OOSOut of Specification
e.g.For Example
Etc.Et cetera

Annexure No.Title
01Format for Annual Product Quality Review

  •  GMP Guidelines



Annex. No. 01 Format for Annual Product Quality Review