SOP For released for marketing for finished product is described in this post which you can follow in the section of the Quality Assurance Department.
OBJECTIVE
This procedure has been established to provide guidelines to be followed for Finished Product to release for sale.
SCOPE
This procedure is applicable to the Quality Assurance Department.
RESPONSIBILTY
Quality Assurance Manager
PROCEDURE
Finished Product release is the process of reviewing each individual document of a licensed product before giving approval for its release onto the market.
The release involves the review of production data and quality control test results by the responsible authority.
The requirements for testing can depend on the legal requirements, the type of product, the manufacturer, the production and control history of the product.
QAM is responsible for ensuring the completion of all records in accordance with the specifications mentioned in the analytical report (Final Product) given in BMR and also the relevant SAP-P of the product to be released for sale.
QAM also check and verify MO, PO, dispensing tags, QC releases, graphs, overprinting, additional issue report, additional return report and FGRN. These documents must be duly completed and signed.
QAM thoroughly check reconciliation and yield of the product and it must be within the prescribed limits of the product to be released. QAM also check and verify the following finished product specifications;
Description of the product,
Printing record which includes Batch No, Mfg. Date, Exp Date, and M.R.P. PRs.,
Pack size which includes both for sale and P/S.
Other packaging components such as leaflets, water for injection, lidocaine 1% solution, inner packing etc.
These above mentioned points must be in the analytical report (Final Product) of BMR.
Beside these also check and verify SAP-P of the product to be released.
If all the actions are meeting the in -house and regulatory requirements, the QAM will release the batch. No product will be released until it meets the required specifications of the product.
QAM will produce two RELEASED labels (FINISHED STOCK), sign and send one copy to Finished Goods Store and other will attach with BMR. The RELEASED label (FINISHED STOCK) includes;
Product name
Pack size
Batch no
Quantity (to be transferred)
Date (of transference)
Remarks
Audit by (BMR)
QAM (sign)
For any unsuccessful inspection or non-conformance QAM will hold the Batch before the non-conformance is investigated and the assignable cause will be determined.
For any critical or serious defect or non-conformance QAM will reject the batch by stamping a red “REJECTED” stamp on the BMR. Appropriate number of REJECTED labels will be produced, signed and send to Finished Goods Store /Production to stick those on to the rejected pallets.
If a batch is reworked, ensure the following things;
Reworked data should be filled out by Production and sent with relevant Batch Manufacturing Record and the calculation of reconciliation is according to the reworking added.
For urgency or to meet the request of partial release by Marketing Department BMR will be reviewed accordingly. Partial release will be given only for packed and transferred units to Finished Goods Store only with QAM sign on RELEASED label (FINISHED STOCK) with remarks PARTIAL RELEASE.
Tags:
QA SOP