SOP On Release of Finished Goods
Objective : To lay down a procedure for the release of finished goods for sale and distribution.
Scope : This standard operating procedure is applicable for the release or hold or reject of finished goods manufactured at all formulation plants.
Responsibility : Production personnel shall be responsible for transferring the product to Finished
Goods Stores with Quarantine status label.
Head Production or designee shall be responsible for raising the request of Under Quarantine Release for Depo.
Head Quality control or designee shall be responsible for verifying the Under
Quarantine Release request.
Officer/ Executive QA shall be responsible for final review of Batch manufacturing records.
Head, Quality Assurance or his/her designee shall be responsible for the release or hold or reject of finished goods for sale and distribution.
Abbreviations and Definitions
BMR : Batch Manufacturing Record; filled / unfilled regulated photocopy of Technical Directions along with other requisite forms/records, which reveals all the information of a batch of a product.
Procedure : Once the batch of a product is packed and “FINISHED GOODS TRANSFER SLIP” is signed by IPQC/IPQA, the same shall be transferred to Finished Goods Stores with Quarantine status by Production personnel.
For Products to be transferred to Central Warehouse Under Quarantine Release
After packaging, the Product list) shall be sent to central warehouse Depo Under Quarantine Release, after receiving the chemical analysis certificate (Excluding microbiological testing) from QC and final release of the product shall take place only after getting the “Certificate of Analysis” from QC including chemical and microbiological testing. “Certificate of Release” shall be issued after review of BMRs. “Under Quarantine Release” for Depo shall be requested by Head-Production, checked by Head-QC and finally approved by Head-QA.
After final approval on Release of product, a copy of the “Certificate of Release” shall be sent to Central Warehouse, Depo by QA personnel for further sale and distribution of the product.
After obtaining duly approved finished product “Certificate of Release” from QC, IPQA personnel shall send the complete BMR for final signatures on “Certificate of Release” to Officer/ Executive QA for final review.
Officer/ Executive, Quality Assurance shall review the complete BMR as per respective site SOP for review of BMRs.
After the complete review of BMR and analytical reports for accuracy and correctness, the complete set of documents shall be forward to Head QA/ designee for approval / decision on “Certificate of Release” for the following:
“Release of batch” for sale and distribution.
“Under Hold”, e.g. Results of chemical or microbiology are awaited from QC, Stability data is awaited from QC and likewise.
“Rejection of batch”, e.g. Product is not meeting the acceptance criteria.
After approval on Release or Under Hold or Rejection from Head QA, QA-personnel shall send a photocopy of “Certificate of Release” to store and IPQA personnel for information.
Note: In case the batch of the product is rejected, then the batch shall be destroyed as per SOP Titled- “Destruction of Finished Goods”.
After receiving the copy of “Certificate of Release” from QA, IPQA personnel shall change the finished goods status from Quarantine Finished Goods to Approved Finished Goods and after that based on marketing requirement further sale and distribution shall take place for finished products.
As per requirement of any marketing authorization or technical contract, the finished product is required to be finally released into a specified market through a qualified person e.g. for EU or a business partner, then the necessary documents like “Certificate of Release” or/and a copy of batch manufacturing record or/and any other specified document or samples shall be sent along with the consignment.
Export products shall be released for sale and distribution to destination country from Finished Goods Stores it self or as per any current procedure requirement by statutory compliance.
Note: In case; if a business partner demands certificate of analysis/ certificate of release, a copy of the same shall be provided to marketing collaborator.
For export consignments, requirements shall be complied as laid down in the in house operating procedure titled: “Handling of export goods for final dispatch”.