SOP for Product Quality Review (PQR)

The objective of carrying out Product Quality Review (PQR) is to establish that the product is manufactured as per approved procedures and the trends of results of critical quality attributes are well within acceptable limits. PQR will also address the review of raw and primary packaging materials used, process validation & revalidation, analytical method validation, cleaning validation and revalidation, stability testing reports, yields, change controls, out of specification results, deviations, failure investigations, CAPAs, rework and reprocessing, market complaints report, trend analysis data, vendor addition/deletion, supplier performance review, retention sample review, batch documentation, drug authority (legal) notices, equipment/utility required, environmental monitoring, trend of water quality etc. done during the review period.

This procedure applies to all product manufactured at (Company Name) and is carried out for products manufactured for during calendar year e.g., January to December.

1. It is the responsibility of the Manager QA or his/her nominee of the location to ensure that PQR is carried out for all products manufactured at the site.

2. All concerned department heads have the responsibility to provide relevant data required for the review.

Executive Director- Quality

** Selection of batches

** Select the all batches of a product manufactured in the review period.

** The batches which are reworked / reprocessed must be included in annual product review.

** Where only 1(one) to 3(three) batches were produced during the year, the review period might be longer than 1(one) year. The Chosen review period for such cases should include at least 3(three) batches or should be performed after 2(two) years. If after 2(two) years less than 3(three) batches have been produced, a PQR should be established as soon as 3(three) batches have been produced.

** Schedules for Review

** A suitable schedule has to be drawn up by assigning products to person so that review of all products is completed for the stipulated period. The compilation data should preferably to be completed within one month after receiving all data of last batch of evaluation period.

** Review of Batch Manufacturing and Packing Records

** Review the batch production records for the following particulars:

** Review the batch production and packing records of all the batches selected for PQR and record the details like batch numbers, batch size, final yields etc.

** Review any batch rejections and reprocessing or reworking done during the review period. In such cases highlight the reason, and record the corrective action taken.

** Review the process deviation reports duly adequately investigated, completed and approved.

** Compile the yield data and prepare the trend charts. Analyze the trend charts, identify and investigate any discernible trends, which are within acceptable upper and lower specifications. Attach the trend charts as a part of PQR report.

** Review in-process control data for key process steps carried out during the manufacture and highlight critical deficiencies if any and corrective action(s) taken for containing such deficiencies.

** Review of Environmental Condition

** Review all deviations (if any) related to environmental conditions of manufacturing area.

** Review of Analytical Reports

** For all the batches under product quality review verify all the analytical reports for the following:

** Validity of analytical specifications and methods for the products, raw materials and primary packaging materials employed.

** Any out of specification analysis and re-testing carried out with explanations for the same.

** Review the analytical results for all critical attributes for all products of all dosage form.

** Compile the analytical results of the product quality parameters and prepare the trend charts. Analyze the trend charts, identify and investigate any discernible trends, which are within the acceptable upper and lower limits. Attach the trend charts as a part of PQR report.

** Review any specification changes and also any new analytical instruments added for the testing of the product and raw/primary packaging materials involved in manufacturing the batches for PQR.

** Review the calibration/qualification status of instruments used in the analysis of the batches under review.

** Review of Stability Study Program and Data

** Stability review data generated for the product during the review period must be verified and critical observations, if any, highlighted with corrective action recommended. On need basis, the review should be extended to previous years as well. Any recommendations for changes in shelf life must be examined. Record any changes to stability testing protocol and methods during the review period. Any stability failure during the period must be reviewed in detail.

** Review of Market Complaints, Returns and Recalls

** Market complaints received during the 12 months period of review should be verified for appropriate closure. The corrective & preventive actions taken subsequent to the complaint investigations should be reviewed in detail. Any recall during the period also must be reviewed in detail.

** Review of Regulatory Actions

** Any regulatory queries with respect to the product under review must be examined in detail. The corrective actions taken and company response to the queries must be examined.

** Review of Validation Status

** Any validation or revalidation exercises carried out for the process or equipment related to the product under review must be reviewed and findings to be highlighted. Corrective & preventive actions (CAPA) taken, if any, must also be reviewed. Analytical method validation and cleaning validation/revalidation performed during review period must be recorded.

** Review of Change Control Documents

** Review all the changes made to the system related to the product under review and reports the impact on the regulatory and or customer requirements.

** Review of Non-conformity and CAPAs

** Review the non-conformities and corrective & preventive actions (CAPA) related to the product directly or indirectly.

** Review of Critical Equipment & Utility performance

** Performance of the critical equipment & utilities used for manufacturing, packaging & testing of the product during the period to be reviewed.

** Review of Raw & Primary Packaging Materials

** All the batches/ lots of raw materials (active & excipients) and packaging materials used for manufacturing & packing of product during the review period to be reviewed.

** Review of Vendor Addition/Deletion and Supplier Performance Report

** Vendor addition/deletion and supplier performance reports of raw materials (active & excipients) and primary packaging materials to be reviewed.

** Review of Retain Sample

** Retain samples (control samples) of all the batches of the finished products to be reviewed every year by visual examination for any evidence of deterioration and observation shall be documented in respective control sample register. A summary report to be prepared based on the visual inspection. The same report will go to the PQR.

** Review of previous PQR Report

** Observations/recommendations of the previous Product Quality Review report to be reviewed.

** Review of Environmental Monitoring

** Annual review of environmental monitoring summary report to be reviewed and a copy of the summary to be affixed as an annexure with the PQR. Any result exceeds the action limit and the actions against the exceed results to be recorded in the review report.

** Review of Water Quality

** Water quality to be reviewed & any out of limit shall be documented in the summary report of water. The same report will be the part of PQR

** Report

** An overall summary of the product quality review report shall be prepared by the person authorized by the Quality Assurance. Any observations or improvements or recommendations for improvements (if any) shall be given in the report.

** The report should include trend charts for all relevant data supporting the review.

** The report should include a summary and recommendations for escalation of CAPAs against the deficiencies like out of trend; out of specification data etc.

** All Heads (or designees) of Production, Quality Control, Validation and Quality Assurance will check and review the report. Head of quality (or the designee) will approve the report.

** If any major deviations observed with respective system or process and quality, it is to be reported to Executive Director-Quality, Executive Director-Manufacturing, Head of Production and Head of R & D for evaluation and advice. If advised the revalidation shall be initiated immediately.

** The copy of Product Quality Review report can be provided to contract manufacturer through Regulatory and or Business Development as per requirement.

** Document Numbering:

The unique document identification number of Supplier Assessment Report shall be consisting of 13 characters broken down as follows –

( – – – ) ( / ) ( – – ) ( / ) ( – – – ) ( – ) ( – – )
Document Code Slash Year Slash Sequential No. Dash Revision No.

e.g. PQR/13/001-00

PQR is the Product Quality Review
/ is separator
13 is the year 2013
/ is again a separator
001 sequential number
– is the separator
00 is the revision level of the document. When new document is initiated the revision number shall be ’00’. The next revision would be ’01’ and so on.

** Retention

** The product quality review reports shall be retained in QA documentation area.

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