VERIFICATION AND TESTING OF FINISHED GOODS
PURPOSE:
To provide the procedure for testing of finished Goods at outside laboratory and physical verification to ensure that product is complies with specification criteria.
SCOPE:
This Procedure is applicable for finished product testing at outside lab and receive at depot.
Procedure for Physical verification of finished product is applicable for new product, shifted product and pack size revision, product manufactured for Indian market and ROW market.
RESPONSIBILITY:
Designated Person- Corporate Quality & Compliance:
To track the new products and existing products from SAP, batches applicable for analysis.
To send a list of selected batches of finish goods, to depot, accordingly depot personal will send the samples to External Testing Lab.
To prepare the test request for analysis.
To review the test results or report which is received from External Lab.
To circulate the releasing mail to respective departments for first batch of new product.
To circulate the daily releasing letter/Status of routine products.
To execute for Physical and organoleptic evaluation of all new product shifted product product with revised pack size.
Section Head -Corporate Quality Compliance:
To review the COA received from External Lab/GTL Lab.
To coordinate with plant, if any failure or non-compliance observed in results of finished goods or in case of joint analysis is require.
To review the tracking record of External Lab testing.
To review and approve executed for Physical and organoleptic evaluation of all new product/shifted product/ product with revised pack size.
Designated Person-Mother Depot:
To withdraw the require quantity of finish goods, identified by CQG designated person, from SAP.
To prepare the FG Issue Note and dispatch it along with the samples to external testing lab/GTL Lab & copy of FOG Issue Note shall be sent to CQC.
Business development :
To propose the product detail for physical and organoleptic evaluation of all new product shifted product/ product with revised pack size.
To provide the Information of Export product which shall be tested at External testing lab from manufacturer/ Depot.
PROCEDURE:
Pre-requisite for testing of product at External laboratories :
A technical agreement shall be available between Company and external testing laboratory,
The samples shall be sent to the external lab after signing of technical agreement &/or audit as decided by the CQC Head. The designated -CQC person or if required section head shall visit the external testing lab as and when require to ensure that the lab is following the prescribed standards or parameters of testing as per the agreement or to attend any outstanding issue .
Product Selection for testing for Domestic Market :
Lab test Hold report is generated by SAP on daily basis as per logic build in SAP. CQC person receive the mail on daily basis for Hold batches detail.
SAP generated report shall be referred for batches applicable for testing at external lab.
For New Product or shifted product, first three batches shall be locked by SAP (based on the applied logic) & same shall be sent for testing to External testing lab/CTL Lab.
After completion of three batches, After completion of three batches, SAP Logic shall be updated to track every 5th batch till 50 batches.
After completion of 50 batches of routine products, logic shall be revised as periodic random product testing preferably every 10th batch.
Testing of products supplied for Domestic Market :
Product Request shall be prepared by designated CQC person & same shall be provided to the designated depot person for sample collection.
Depot person shall dispatch the sample for testing purpose at External Testing Lab/GTL Lab as per received information in request for product testing.
Depot person shall prepare the FOG Issue Note.
The depot person shall dispatch the samples and FOG Issue Note to External Testing lab.
Depot person shall provide the details of sent sample in excel format to designated- QQC person for Information.
Designated GQG person shall prepare the test request and same shall be shared with external lab along with STP, Specification and WS/Placebo/ impurity/Others for testing of Finish
Goods, if require.
New and shifted product Information should be highlighted in test request.
Meanwhile CQC person shall update the External lab sample testing tracking record. This tracking record shall be updated time to time based on the status of sample testing. Soft copy shall be maintained by CQC person and this folder shall be secured and access controlled to restricted persons.
The designated CQC person shall get the sample receiving status from the external testing lab and convey the priorities, if any.
The designated CQC person shall take Follow-Ups via mail or telephone from external testing lab regarding, if require.
On receipt of scan copy of COAs from the external testing lab the designated CQC person shall review the COA’s for adequacy and analysis results.
In case of any discrepancy observed, the CQC designated person shall communicate the discrepancy to the External testing Lab, under intimation to the Section Head CQC.
On receipt of corrected COAs from the External test Lab, the designated CQC person shall review the COAs and accordingly information shall be updated in tracker.
Note: CQC personnel can arrange required analytical data from out lab where testing is being performed as per requirement basis.
In case of any questionable results observed, same shall be informed to respective site. Joint analysis shall be arranged, if requested by manufacturing site. Joint analysis shall be arranged at lab where failure result observed.
If joint analysis results found satisfactory, batch shall be released further. If batch results not complying with the specifications then the batch shall be returned to the manufacturing unit to investigate the root cause and implemented CAPA for further batches.
The CQC person shall transfer the restricted stock to unrestricted stock in SAP for further distribution if results found satisfactory from outside laboratory.
The designated -CQC person shall prepare the release letter and circulate to the mother depot & other concerned department at HO for Release letter.
In case of new product, the designated -CQC person shall circulate the results to all the concerned members at Mother Depot and HO, for New product Release status.
Upon completion of all the relevant information’s in the External lab sample testing tracking record the section, section head shall verify all the entries.
Testing of Products Supplied for Export Market :
Every batch for the Export market shall be sent for analysis or as Information received from the Business Development team (Export).
The BO team (Export) shall provide standard Test Procedures and the Working Standards/Impurities for each product.
The designated CQC person shall enter all the details of the product, in the tracking record of products for Export.
CQC person shall send the Information of batch release to the International business and concerned person along with a scanned copy of the COA The designated -CQC person shall send an original copy of COAs to the International Business and other copies of the same shall be kept at CQC for record purpose.
Testing of Trial batch sample :
Trial batch samples shall be provided to CQC personnel from the BO team.
Appropriate quantity of the sample along with its Specification, STP, working standard & Impurity (As applicable) shall be provided to the CQC personnel from the BO team, If required.
The designated CQC person shall enter all the details in the External Testing Lab Tracking record (internal) for the trial product.
The designated CQC person shall prepare a test request for the given product. Test request along with the sample, STP & WS shall be sent to the External Lab for analysis.
The designated CQC person shall take follow-ups, via mail &/ or telephone from the testing lab for the testing status of the samples.
Upon receipt of the results, the designated CQC person shall review them and convey the same to the BD team and the CQC section head.
Physical and Organoleptic evaluation of products :
The first batch of new product/shifted product/ product with Pack size revision shall be considered for physical and organoleptic evaluation.
The first batch of new products shall be locked in SAP as per the logic built-in system.
The depot person shall send a sample of the first batch of new product/shifted product/ product with Pack size revision along with a FOC issue note to designate BD/CQC person.
CQC person shall execute for Physical and organoleptic evaluation. This Templet shall be modified based on
dosages form requirement.
The Section head, CQC shall approve the product for physical and organoleptic evaluation.
The CQC-designated person shall communicate the results visually & or organoleptically evaluated samples via mail to all the concerned persons at HO, Depot & the CQC Head.
Record Maintenance:
Note: All Annexures shall be used as a soft copy and Annexures shall be secured restricted controlled.
