Release of finished products

Release of finished products

OBJECTIVE:

To lay down the procedure for the release of finished products.

PROCEDURE :

Ensure that the Batch Manufacturing Record has been reviewed and audited by Production in all aspects. The reconciliation of the materials and product yield is carried out at the respective stages of the operation.

Ensure that the Production Manager has reviewed the completed BMR before it is submitted to Quality Assurance for final audit and release of the Finished Product for distribution.

QA personnel shall review & verify the following points before preparing the release order.

  • Review the Batch Manufacturing Record as per the respective SOP.
  • Verify that the product has been approved by Quality control with respect to its testing as per the Product release specification.
  • Finished product COA is attached with the BMR.

Verify the Quantity being released from quantity transferred to Finished Goods Store on ‘Product Transfer Note’ and attached with the BMR.

After verification QA personnel shall prepare a ‘RELEASE ORDER’ in duplicate, giving the details of Product Name, Batch details, Analytical Reference Number, Break-up of packed quantity, and total quantity released for sale on basis of the Batch manufacturing.

A serial no. shall allocate to the release order and the signature with the date shall be done by QA personnel.

The signed Release order along with the Batch Manufacturing Records shall submit to the QA Head or his designee for the final release of the Finished Product.

QA Head shall final review the BMR & put his sign with the date on BMR and release order.

QA Head shall forward BMR & release the order to QA personnel.

QA personnel shall send the Second copy of the ‘RELEASE ORDER’ (Green carbon copy) to the Finished Goods Store so that the dispatch of Finished Products shall be planned.

The First copy (Green copy) of the release order shall be attached to the batch manufacturing record and QA personnel shall finally archive the BMR in the documentation cell.

In case a batch has to be released partially, the BMR shall be completed up to that stage & reviewed by Production and QA.

After review of BMRs, if QA personnel shall found all the specifications of the product meeting with the finished product specification till stage then a ‘PARTIAL RELEASE NOTE’ shall be prepared for a partial quantity of batch by QA personnel and shall be approved by QA Head or his designee.

In cases of other than the bifurcated batch, the partial Release status shall be mentioned in BMR, while in case of the bifurcated batch, the final release status shall be mentioned in BMR.

If all bifurcated quantity is being released on the same date, then ‘RELEASE ORDER’ shall be prepared only, no need to prepare ‘PARTIAL RELEASE NOTE’.

For the tests, which take a longer time for completion e.g. Sterility test, Microbial limit test, and Suspension stability analysis, to save the time of transportation, a ‘PROVISIONAL RELEASE’ shall be given for dispatch of the products up to the Distributors.

Dispatched products through provisional release shall meet finished product specifications except e.g. Sterility test, Microbial limit test, and Suspension stability analysis, and further dispatch to market, the product shall be upon confirmation of product final release.

The final release for further sale shall be given only after completion of the above-referred tests e.g. Sterility test, Microbial limit test, and Suspension stability analysis, by preparing a ‘RELEASE ORDER’  in a green copy of the release order and forwarding to Finished Goods Store personnel and distributions for the final release.

QA allocates the release order number in the release of finished products, as given below:

FRN/XX/YYY

FRN    –       Finished Goods Release Number

XX      –       Last two digits of the running calendar year

YYY   –       Serial number (0001 to 9999)

The final release order shall attach with Batch manufacturing Records and hand over to the Documentation Officer/Executive.

Records the release of the finished product in the Logbook for batch release of finished products.