To lay down the Procedure for preparation of Product Quality Review.
This procedure is applicable to provide the guidelines for preparation of Product Quality Review at
3.1 QA Department shall be responsible for follow the procedure mentioned in this SOP.
4.1 QA Head shall be accountable for compliance of this SOP.
5.0 ATTACHMENTS :
Product Quality Reviews report format Attachment – I
6.0 PROCEDURE :
6.1 Numbering of PQR report.
PQR Document number should be allotted as PQR/XX/YYY where,
PQR : represents document code (Product Quality Review)
XX : represents the year, when PQR is prepared.
YYY : represents sequential number.
Report of PQR should be prepared as per format mentioned in Attachment-I.
6.2 Summary of Product Quality Review
A brief summary of the PQR should be made for the batches after manufacturing of minimum 10 batches or as per party demand.
6.3 Batches manufactured
A review and number of all batches manufactured including failed batches / rejections during the review period for a specific product should be listed in the PQR. Gaps in batch numbering, e.g. due to validation lots pending approval or orders are cancelled before any production commenced, should be explained in detail.
6.4 Raw materials from new sources (e.g. API, excipients and packaging materials)
Raw materials (e.g. API, excipients and packaging materials) should be listed if purchased from new source for the manufacturing of the product concerned.
6.5 Analytical results (Critical in-process control result & critical analytical test results of finished products)
The comparison of the particular applicable specifications and initial analysis results of all or of representative number of batches that were produced during the defined review time frame should be included. These data should include all the critical quality parameters for a specific product and are to be reviewed.
Quality parameters examples for drug product are:
6.5.1 Critical In-process control result
Critical In-process control result should be collected from Batch manufacturing record and Batch packing record during the following stages of manufacturing as applicable.
- LOD, Blend Assay and Yield at different stages of manufacturing of the product..
- Average weight, Uniformity of weight, Hardness, Thickness, Disintegration Time, Friability
Dissolution ( if applicable ), Assay & Yield of compressed tablets or filled capsules.
- Average weight, Thickness, Disintegration Time, Dissolution, Assay and Yield of coated tablets.
- Related Substances
- Assay (Active, Preservatives)
- Microbial Counts (Total Bacterial; Total Fungal, Pathogens)
- Batch yield
6.5.2 Critical analytical test results of finished product
Critical analytical test results of finished product should be collected from Certificate of Quality as per product specification. This data may include as applicable.
- Description, Average weight, Uniformity of weight, , Hardness, Thickness, Disintegration Time,
Friability, Dissolution of finished products.
- Impurities (HPLC & GC)
- Content uniformity
- Microbial results
- Other critical parameters.
6.6 Deviations and Out of Specification:
A review of all investigations related to deviations and OOS should be performed including a review of adequacy of previous corrective actions.
6.7 Change controls (Change of specifications and process revisions):
All change controls raised should be listed in the PQR. This list should include details of changes were made in of specifications, manufacturing and/or packing process revisions.
6.8 Review of any changes of the equipment used during manufacturing and packing of the product.
All information regarding change of any equipment that was used during manufacturing or packaging process of the particular product should be included in the PQR.
6.9 Stability review:
A summary of stability data of all batches on stability (follow up stability program), which represents the manufactured batches for distribution. These data should be reviewed and compared with data from previous year review to assure that no negative trend has developed and no stability failures occurred, and that the expiry period is still appropriate.
6.10 Customer complaints
Any customer complaints received from the respective market during the time frame of the review should be listed in the PQR. The list should include following details:
- Product Name & Batch Number.
- Nature of complaint
- Root cause.
- Conclusion made as a result of the investigation
6.11 Market Withdrawals, Recalls, and Regulatory Alerts
Any batches withdrawn or recalled, or regulatory alerts made from the respective markets during the time frame of the PQR should be listed along with the reason for the recall or withdrawal.
6.12 Returned / Salvaged of drug products
A listing of any returned/salvaged drug products should be included. This should include the batch number and the reason for returning. If investigations were performed the result and the decision on the final use should also be listed.
Any returned products that are considered complaints should be evaluated as stated under point of customer complaints.
6.13 Review of annual visual examination of retain samples
Representative retention samples should be visually examined once in a year.
6.14 Qualification status of relevant equipment and utilities (HVAC system, Water system and Compressed air system)
Changes/ deviations to the qualification status of relevant equipment and utilities should be summarized.
6.15 Review of contractual arrangements
A review of contractual arrangements with contractors or suppliers should be included to confirm the agreements are up-to-date.
6.16 Trend analysis evaluation and graphical representation of analytical data
Statistical analysis should be performed to assess the batch uniformity and integrity of drug products. Since the process evaluation is performed, graphical representation of parameters (i.e. Control and Acceptance criteria, etc.) will be useful to study the historical behavior patterns of the process and aid in the visual evaluation of out-of-specification values and/or trends that may translate in abnormal variations. Individual trends shall be analyzed and conclusion shall be written.
6.17 Recommendations and conclusion
All data included in section 6.3 to 6.16 should be evaluated as a whole and these data should be summarized and recommendations for actions provided. The responsibility for coordination and supervision of follow-up measure is with the QA.
6.18 All batches manufactured in the calendar year or review period (January to December) should be included in the preparation of PQR.
6.19 All batches manufactured including rejected batches during the review period should be included in the PQR.
6.20 All PQRs should be conducted with the objective of verifying the consistency of process parameter and to highlight any trends.
6.21 The time line for completion should not be longer than 3 months past the end of this 12 month period.
Drug Cosmestic Act 1940 and Rule 1945.
QC – Quality Control
QA -Quality Assurance
RSD-Relative Standard Deviation
9.0 DISTRIBUTION LIST:
10.0 HISTORY OF REVISION:
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