SHELF LIFE EXTENSION OF EXISTING COMMERCIALIZED PRODUCTS
PURPOSE:
To define a procedure for shelf life extension of existing commercialized products.
SCOPE:
This procedure shall be applicable for shelf life extension of existing commercialized products which comprises volumes of Domestic market.
RESPONSIBILITY:
Site Quality Assurance
To provide stability study data for review/evaluation.
To provide stability sample/control sample as per requirement for testing at outside lab.
To test stability sample/control sample/market sample as applicable.
Logistic Department/ Depot Person:
To provide sample (near expiry/expired) as per requirement for testing at respective manufacturing site /outside lab.
Corporate Quality & Compliance:
To arrange required stability data from respective manufacturing site.
To evaluate stability study data of ongoing/ existing products.
To review analytical results of tested sample (expiry/near expiry/control) as applicable.
To recommend shelf life extension of existing commercialized products.
To convey the extended shelf life to BOP-Business Development and Planning BOP to update the shelf-life in material master after receipt of product with
extended shelf-life at depot.
Corporate Quality & Compliance Head:
To approve/reject shelf life extension proposal of products.
To ensure implementation and compliance to this Standard Operation Procedure.
DEFINITIONS:
Shelf life: Shelf life is the period, from the date of manufacture, that a finish product is expected to remain within its approved specification limit, provided that it is stored under the conditions defined on the container label.
PROCEDURE:
Procedure for plant stability study evaluation for shelf life extension:
Site QA shall provide updated stability study (accelerated/ real time/ long-term data) for evaluation.
At least three batches of stability study data shall be provided by respective manufacturing site of current ongoing formulation. CQC shall evaluate provided data.
Site QA shall update to CQC if any recent changes being carried out in formulation/MFG process/quality attributes.
Procedure for collection of sample from manufacturing site for analysis:
CQC person should inform to site QA to provide the samples of selected products for assessment.
Site QA shall provide current age stability sample for testing purpose at outside Laboratory (if available near expiry), In case of un-availability of stability sample, near expiry or expired batches sample shall be provided by manufacturing site for outside laboratory for testing/ analysis and detail of samples shall be shared with CQC.
On getting required samples, CQC shall advise to plant QA-QC/outside lab to perform testing of same samples (batches) and co-ordinate with the outside lab/site QA/QC for obtaining analytical results.
Procedure for collection of expired or near expiry batches from depot for analysis:
CQC shall arrange the detail of near expiry/expired samples from the SAP (availability of sample at depot/market) as per requirement.
After getting adequate detail of samples from the SAP, CQC shall select minimum two batches of each product (near expiry/expired/expired+6 month’s samples) as per criteria of worst case.
CQC shall share the detail of selected product/batches (near expiry/expired/expired+6 month’s samples) with depot person/logistic department to confirm the availability of required samples at depot/market.
After confirmation, required quantity of samples shall be dispatched from the depot to outside lab & respective manufacturing site along with sample details and same shall be shared with CQC.
After receiving of sample at respective location, CQC person shall advise/co-ordinate with outside lab/ respective manufacturing site for the testing of samples.
After completion of testing of samples, the location QC (manufacturing site/outside lab) shall share the results/test report of samples with CQC person for evaluation purpose.
Shelf life extension procedure of shifted/ technology transferred products:
For shifted/ technology transferred products shelf life at transfer site shall be same as applicable for transferring site.
In case, if one product is transferred from one site to another and there is a requirement for shelf life extension of Product at mother site (transferring site) then it can be extended based on required assessment, further shelf life at transferred site cannot be extended until unless 03 batches data will be available as per requirement.
A production activity shall be hold at TT receiving site after manufacturing of 03 batches on existing shelf life and stability shall be monitored. Accordingly, shelf life extension of technology transferred products can be done by transferring site only on the basis of ongoing stability study and near expiry/expired/expired+06-month sample.
Shelf life extension procedure of products with respect to concurrent stability approval
For product which are being approved based on concurrent stability study, respective manufacturing sites will share stability study after every 6-month test frequency and the same shall be reviewed by CQC.
Shelf life extension of such products can be done only on the basis of concurrent stability study and market/control/stability sample analytical test results of outside lab and respective manufacturing site as per criteria define.
Procedure for shelf life assessment/extension of products with respect to change control:
If a product is being manufactured by a respective manufacturing site and on the basis of required data shelf life is being extended and post extension of shelf life if any change carried out in product, same shall be re-evaluated w.r.t impact on quality attributes.
For running/existing product, if any change is being carried out at respective manufacturing site w.r.t formulation, pharmacopoeia change, process, vendor change, material (major excipients) etc. and trial is being conducted for the same then shelf life of products shall be re-assessed based on the criticality/impact of change on product quality attributes. Shelf
life shall be recommended for such circumstances based on current assessment instead of existing shelf life.
Shelf life extension of existing products.
Supporting stability data: Commercial three batches manufactured at commercial scale met the approved stability specifications.
Stability conditions: Long term (12M/15M) and accelerated (6M) conditions stability study data with no significant changes.
Analysis of current age stability sample/control sample (expiry+06 month)/marketed sample (marketed sample of 15 to 20 month age) shall be carried out at outside laboratories as well as manufacturing site.
If 6 months expired market sample / current age stability sample not available, then other available batches / near expiry or expired control sample (having same formulation) can be tested at both locations (outside lab and manufacturing site).
Based on successful review of stability study data and analytical results of outside laboratories conclusion can be summarized for extension of shelf life from 12/15 months to 18 months or 24 months or 36 months (as applicable)..
Note: For shelf Life extension assessment following criteria for stability data evaluation to be followed:
• Stability study data shall be considered for evaluation for only current ongoing formulation/of 03 batches (batches taken in PV) along with 02 batches annual study.
• For any out-of-trend stability results, investigation required.
• For out-of-specification stability results ‘investigation required.
• No Formulation changes have been made for the applicable product.
• No critical changes to the manufacturing process.
• No final product market container-closure system changes.
• Apart from ongoing formulation assurance, need to check that no recent changes carried out in PPM, API vendor, Grade etc.
