Product Quality Review

 

Product Quality Review, to verify the consistency of existing process, to check the appropriateness of current specification for both starting material and finished product to highlight any trends and to identify the product and process improvements also to ensure that the review is consistent in line with technical agreement and dossier, where applicable.

 

Product quality review is an evaluation process conducted annually to give an organized and comprehensive summary of data of all production, analytical, stability, deviations, change controls, out of specifications, out of trends, customer data (complaints), and product recall, etc. which assess the quality standards of each drug products, drug substances with an objective of verifying the consistency of existing process, the appropriateness of current specifications to highlight any trends and to identify product and process improvements.

Product quality review (PQR) should be prepared annually, all the product batches manufactured in a calendar year of January to December shall be considered which should be completed before starting the financial year.

In case less than ten batches are manufactured in the year, Product Quality Review should be prepared considering data from cumulative batches of preceding three years. Minimum ten batches shall be considered for review. 

Product quality review should be considered Starting Materials and packaging Material,  review of starting material and primary packaging material used for the product, especially those form new source and in particular the review of supply chain traceability of active substance.Identify all the starting material, excipients and packaging material received in the review period and used in product manufacture. 

The review of manufacturer and or supplier who is supplying the primary packaging material shall be taken based on the approval and rejection record of the consignment received. Details of rejection and reason should be recorded. 

The review shall cover verification of changes in the specifications, vendor or starting materials and packaging materials used for the product, if any impact of such changes on the quality of the product.

Summary of in-process results of all the batches considered while preparing the PQR should be represented. The trends of the results shall be prepared and presented suitably. Conclusion and recommendations, if any shall be documented. 

Summary of Finished Product results of all the batches considered while preparing the PQR should be represented and trends of the results shall be prepared & same should be presented . Conclusion and recommendations, if any shall be documented. 

-          Tablet Finished Product: Description/identification, average weight of tablets, disintegration time, dissolution, related substances, impurities and assay or any other relevant test but not be restricted to these parameters only. 

-          Dry Powder for Oral Suspension: Description/identification, pH, weight per ml, related substance Assay etc. but not be restricted to these parameters only. 

Note: in case of qualitative test, data shall not be trended. However same shall be reviewed and any failure shall be recorded. 

PQR shall include the version number of BMR’s, BPR’s specification and STP’s which were used to manufactured / testing of product in the review period. Brief description or reason for change shall be mentioned in the PQR. Validation/Re validation status also should be review and same should be recorded.

All OOS/OOT should be reported during review periods i.e API,PM,FP etc.

All planned and unplanned deviations relevant to product during the review period shall be recorded and summarized. 

All related corrective and preventive action shall be included in the PQR. Similarities about the failures and CAPA’s taken to prevent re-occurrence shall be recorded, apartfrom that non-conformances observed for the product in the review period shall be recorded.  

All batches that failed to meet specification(s) and the related investigation should be captured in the PQR (along with reason for rejection) and a summary of number of batches / products, reason of failure, investigation of failure and CAPA should be included. 

It shall cover the study of all changes to the facilities, documentations, analytical procedure and process/ product etc. during the review period and its impact on quality of finished product; same shall be recorded in PQR. Any corrective action derived from these changes and effect of these changes on product quality shall be summarized. 

Marketing authorization should include a review of marketing authorization / dossier variation submitted / granted / refused, including those for third country (export only) dossiers during the review period. 

A review of results of stability programme and adverse trends shall be recorded in PQR, A summary of number of batches charged for stability with reason for selection (Validation, annual batch etc.) shall be recorded and status of the progress of stability studies (summary sheet) sheet be mentioned in the Product quality review. 

 A review of product complaints, adverse drug reaction, products returns or recalls and the investigation shall be performed and recorded. Nature of complaint, reason of recall or return along with investigation to prevent recurrence should be recorded in Product quality review.

 All such post marketing commitment should be  captured in product approval package, prepared by regulatory affairs and from this package data shall be captured in respective PQR, All post Marketing Commitment compliance shall be verified and captured in respective product quality review.

Statistical data interpretation

The data where quantifiable, shall be trended and analyzed to determine if the process is in control. Where the data allows, graphical representation shall be provided. Interpretation of data shall be done in the form of plotting control chart.

± 3 Sigma shall be calculated for each test as below:

+ 3 sigma = Average + (3 x standard deviation)

- 3 sigma = Average- 3 x standard deviation) 

The conclusion and recommendations drawn from the PQR shall be recorded