You are on page 1of 12

HERMES

STANDARD OPERATING PROCEDURE


TITLE: PROCEDURE FOR RELEASE OF FINISHED PRODUCT FOR DISPATCH TO MARKET.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/019
EFFECTIVE DATE : 06-May-2019 NEXT REVIEW : 05-May-2022
REVISION NO : 04 PAGE NO : Page 1 of 12

Prepared by Checked by Approved by


HERMES
STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR RELEASE OF FINISHED PRODUCT FOR DISPATCH TO MARKET.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/019
EFFECTIVE DATE : 06-May-2019 NEXT REVIEW : 05-May-2022
REVISION NO : 04 PAGE NO : Page 2 of 12

1. PURPOSE:

To lay down the procedure for releasing of finished product to market.

2. SCOPE:

This procedure is applicable for all finished products which are manufactured at Hermes Laboratories Pvt. Ltd.

3. RESPONSIBILITY:

Prepared by Checked by Approved by


HERMES
STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR RELEASE OF FINISHED PRODUCT FOR DISPATCH TO MARKET.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/019
EFFECTIVE DATE : 06-May-2019 NEXT REVIEW : 05-May-2022
REVISION NO : 04 PAGE NO : Page 3 of 12

The responsibility of releasing the finished product to market lies with the Head of Quality Assurance.

4. DEFINITIONS / OBSERVATIONS:

Nil.

5. PROCEDURE:

5.1 All the dispatches of finished products to market shall be inspected and cleared by Quality Assurance personnel.

5.2 Ensure that the Blending and Packing of concerned dispatch batches are reviewed by Quality assurance personnel for
correctness and approved batches have been used.

Prepared by Checked by Approved by


HERMES
STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR RELEASE OF FINISHED PRODUCT FOR DISPATCH TO MARKET.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/019
EFFECTIVE DATE : 06-May-2019 NEXT REVIEW : 05-May-2022
REVISION NO : 04 PAGE NO : Page 4 of 12

5.3 After receiving the certificate of analysis from Quality control, Quality Assurance personnel shall check whether the
specifications are meeting the customer requirements. If the specifications are as per In-House, check and confirm
that all specifications are same as per MOA. Also confirm that the results are within the limits.

5.4 Check the raw data in calculation registers, analytical reports, chromatograms of GC, of concerned dispatch batches
in QC against the COA.

5.5 Check and ensure that control samples of all the dispatch batches are retained by Quality Control department.

5.6 While checking the product labels inside and outside of the containers, ensure that the batch number, manufacturing

Prepared by Checked by Approved by


HERMES
STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR RELEASE OF FINISHED PRODUCT FOR DISPATCH TO MARKET.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/019
EFFECTIVE DATE : 06-May-2019 NEXT REVIEW : 05-May-2022
REVISION NO : 04 PAGE NO : Page 5 of 12

date, expiry / retest date on labels are same as mentioned in COA and blending advice. Ensure that the Net weight,
Tare weight and Gross weight are same as mentioned in the packing list and the labels are as per customer
requirement.

5.7 Check the weights of the containers randomly and ensure that the weights are same as mentioned in the packing list.

5.8 All the containers shall be sealed in presence of Quality assurance person.

5.9 The Quality assurance shall also ensure that the truck for delivery is clean and there exists no possibility for
contamination.

Prepared by Checked by Approved by


HERMES
STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR RELEASE OF FINISHED PRODUCT FOR DISPATCH TO MARKET.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/019
EFFECTIVE DATE : 06-May-2019 NEXT REVIEW : 05-May-2022
REVISION NO : 04 PAGE NO : Page 6 of 12

5.10 Quality assurance personnel shall write the description against each checkpoint in Dispatch Clearance Form.

5.11 The Quality assurance personnel shall sign in Dispatch Clearance Form and get approval of In-charge/Head– QA
and hand over duplicate copy of dispatch clearance form along with duplicate copies of product labels, original
copies of blending advice and packing list to the packing in-charge. The original copy of dispatch clearance form is
filed in Quality assurance.

5.12 Quality assurance personnel shall paste the QA released Labels to all containers after the approval of Dispatch

Prepared by Checked by Approved by


HERMES
STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR RELEASE OF FINISHED PRODUCT FOR DISPATCH TO MARKET.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/019
EFFECTIVE DATE : 06-May-2019 NEXT REVIEW : 05-May-2022
REVISION NO : 04 PAGE NO : Page 7 of 12

Clearance Form.

6. RELATED DOCUMENTS:

Nil.

7. ANNEXURES:

Prepared by Checked by Approved by


HERMES
STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR RELEASE OF FINISHED PRODUCT FOR DISPATCH TO MARKET.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/019
EFFECTIVE DATE : 06-May-2019 NEXT REVIEW : 05-May-2022
REVISION NO : 04 PAGE NO : Page 8 of 12

Annexure No. Annexure Title

Annexure-1 Dispatch Clearance Form

Prepared by Checked by Approved by


HERMES
STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR RELEASE OF FINISHED PRODUCT FOR DISPATCH TO MARKET.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/019
EFFECTIVE DATE : 06-May-2019 NEXT REVIEW : 05-May-2022
REVISION NO : 04 PAGE NO : Page 9 of 12

Prepared by Checked by Approved by


HERMES
STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR RELEASE OF FINISHED PRODUCT FOR DISPATCH TO MARKET.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/019
EFFECTIVE DATE : 06-May-2019 NEXT REVIEW : 05-May-2022
REVISION NO : 04 PAGE NO : Page 10 of 12

8. REVISION RECORD:

Revision No. Effective Date Details of Revision Remarks

00 06-May-2010 First issue --

01 25-Jun-2012 SOP changes to current requirements --

Prepared by Checked by Approved by


HERMES
STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR RELEASE OF FINISHED PRODUCT FOR DISPATCH TO MARKET.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/019
EFFECTIVE DATE : 06-May-2019 NEXT REVIEW : 05-May-2022
REVISION NO : 04 PAGE NO : Page 11 of 12

02 10-Jan-2013 Format changes in Annexure --

03 06-May-2013 Periodic Review --

Prepared by Checked by Approved by


HERMES
STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR RELEASE OF FINISHED PRODUCT FOR DISPATCH TO MARKET.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/019
EFFECTIVE DATE : 06-May-2019 NEXT REVIEW : 05-May-2022
REVISION NO : 04 PAGE NO : Page 12 of 12

No revision in document
because no changes in
03 06-May-2016 Periodic Review procedure.
Document sealed as
“Review found ok”

04 06-May-2019 Periodic Review --


3

Prepared by Checked by Approved by

You might also like