Product Quality Review, Purpose :
Product Quality Review, The objective of carrying out Product Quality Review (APR) 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 & primary packaging materials used, process validation & revalidation, analytical method validation, cleaning validation & revalidation, stability testing reports, yields, change controls, out of specification results, deviations, failure investigations, CAPAs, rework & 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, etc. done during the review period.
Scope :
[][]This procedure applies to all product manufactured XX Pharmaceuticals Limited (both General & Sterile Block) and is carried out for products manufactured for during calendar year e.g., January to December.
Definition/Abbreviation:
[][]SOP : Standard Operating Procedure
[][]CAPA : Corrective and Preventive Action
[][]PQR : Product Quality Review
Responsibilities:
[][]The roles and responsibility is as follows:
Executive, QA
[][]Responsible to carry out the periodic review of particular product and prepare a report.
Asst. Manager, QA
[][]Responsible to ensure that a formal review of Drug Product / API is undertaken and reported periodically and demonstrate control of the process and effectiveness of any corrective actions required.
Head of Concern Department
[][]To ensure implementation of suggested CAPA.
Head of Quality Assurance
[][]Approval the SOP
Procedure:
Selection of batches
[][]Select the all batches of a product manufactured in the review period.
[][]The batches which are reworked / reprocessed are used must be included in product quality review.
[][]Frequency
[][]Product quality reviews of Drug Products shall be conducted and documented annually.
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 production record number and 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 are duly adequately investigated, completed and approved.
[][]Record yields of all isolated stages of the product and the yield ranges for all the batches reviewed. Highlight reasons for out of specification yields if any as well as extremes, which are well within limits.
[][]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 in graphical presentation a part of PQR report.
[][]Review in-process control data for key process steps carried out during the manufacture and highlight critical deficiencies.
Review of Environmental Condition
[][]Record the observation for Assurance with environmental condition of manufacturing areas. Critical deviation, if any must be examined in detail to assure how the deviations were taken care of and record observations.
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 critical parameters like assay, dissolution, loss on drying/water content, related substances etc.
[][]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 the retention samples randomly for deterioration.
[][]Compile all the critical analytical data (e.g. assay, dissolution) in a graphical presentation as a part of PQR.
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 report the impact on the regulatory and or customer requirements.
[][]Review of Non-conformity and CAPAs
[][]Review the non-conformities and corrective & preventive actions (CAPA), if any, during the internal quality audits.
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 primary 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 (retention 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 retention sample register. A summary report to be prepared based on the visual inspection. The same report will go to the PQR.
Review of previous APR 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.
Report:
[][]An overall summary of the annual product review report shall be prepared by the person conducting the review.
[][]Any other 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 actions to be initiated for any deficiencies.
[][]Document Numbering:
[][]Annual Product Review report shall be numbered as follows:
=>PQR/XX/YYY
=>Where ‘PQR’ represents for Product Quality Review.
=>‘XX’ represents the last two digits of the year (e.g. XX for 20XX).
=>“YYY’ represents for serial number of the PQR report.
Annexure: Product Quality Review
N/A