SOP ON BATCH RELEASE SYSTEM OF FINISHED PRODUCT
PURPOSE: To lay down a procedure for release of finished products for distribution.
SCOPE: This SOP is applicable for release of finished product manufactured.
RESPONSIBILITY: Preparation of SOP: Officer/ Sr. Officer.
Checking and Review of the SOP: Executive/Sr. Executive
Approval of SOP: Head of Department/ Assistant Manger
Authorization of SOP: Head QA/Designee
Production Head/Designee: For completeness, correctness of BMR, BPR.
QC Head/Designee: Analytical testing and Preparation of COA.
IPQA Personnel/Designee: To review batch manufacturing, Packaging and analytical records for batch release.
Head QA/Designee: Batch release.
ACCOUNTABILITY: The accountability of implementation and compliance of the SOP is Head QA.
PROCEDURE:
Definitions:
Finished Product: A Product in the marketable pack is classified as finished product. Practically a transportable pack, i.e. a shipper containing the salable pack (in retail) is considered the finished product.
Quality Review: Before a finished product is released for sale or distribution, the complete production and control records must be reviewed and assured satisfaction about the entire stage in the control process before the product moves out of the manufacturing premises.
Batch release document: All relevant paperwork for a particular batch, including samples of printed cartons, leaflet, shipper labels, Line Openings, Line Clearances records, etc. and collecting them together.
Finished products are packed into the final shippers as per the standard packing instruction present in Batch Packing Record.
Production officer and packing supervisor is responsible for packing of finished product as per the standard packing instructions.
In-Process Quality Assurance Personnel monitor and perform the different packing control tests and to ensure the fill value/standard coding details.
Production personnel prepare finished goods transfer Note (in Triplicate) after the completion of whole batch packing/part batch packing as per Format the FGTN no. Shall be given as G/XX-YYY.
Where G denotes General, XX denotes the last two digits of current year, next character is “-” and last three digits YYY are continuous serial number.
Production officer to compile all the attachments of the Batch Packing Records (BPRs) Viz., packing material dispensing tags, specimen sample of blister/carton/product label/shipper label as applicable along with compiled Batch Manufacturing Record (BMR) and its attachments and and submit to In-process Quality Assurance Personnel.
IPQA Personnel to attach the In Process Quality Assurance Report to BMR/BPR and verify the reconciliation rejected material destruction, recovery details, yield reconciliation, completion of Signature/ date and other investigation, if any incase of deviation.
The certification of finished product batch performed by a qualified person signifying that the batch is in compliance with GMP and the requirements of its marketing authorization. This represents the quality release of the batch.
IPQA personnel to check the packed shippers against the parameters mentioned in checklist.
All shippers should be checked for appearance, label details and in random should be opened to see the details/ fill value of the inner most container.
Sample for identification, if required shall be drawn from the packed finished product.
If satisfactory submit the duly signed Finished Product/ Goods Transfer Note, BMR/BPR along with all attachments to Executive-Quality Assurance for review.
Quality Assurance reviews the Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) and ensures all deficiencies (If any) corrected.
Verify all check point as per the “QA Release Check List.
Hand over the two copies of “Finished Good Transfer Note” to Production and Warehouse Personnel.
Production Personnel transfer the finished goods to stores along with approved copy of finished goods transfer note.
Finally qualified person ensures the completion of Batch document, Analytical reports, IPQA reports, and QA release check list completion and to approve the Finished Product Transfer Note indicating the approval for transfer of batch to stores.
QA issue the “Batch Release Certificate”
Attach a copy of finished goods transfer note and original Batch Release Certificate and finished product release report along with BMR/BPR review check list, BMR/BPR deviations/ deficiencies form and filled QA release check list to the Batch document and archive in Quality Assurance.
Qualified Person (QP):
Qualification/Experience: The QP must have relevant qualification and experience in the manufacture and quality control of finished pharmaceuticals formulations as required.
Education: He / She should have at least four years of theoretical and practical study In pharmacy or graduate / postgraduate in medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology.
Experience: He / She should have minimum 5 years of practical experience in pharmaceutical manufacturing / Quality Assurance / Quality Control.
He/ She should have in-depth knowledge of manufacturing process, controls and QC.
He/ She should have the knowledge on current Regulatory Guidelines, PIC/S, WHO
GMP, EU and Schedule M.
Certification process: The QP shall be trained and evaluated as per SOP.
Certification of QP as per SOP and List of QP shall be recorded.
Re-certification: Periodic re-evaluation shall be done once in 2 years. After the
Satisfactory evaluation, Quality Assurance Head / Head of department / Designee shall issue the certificate for Qualified Person for batch release as per Format.
REFERENCE: Standard Operating Procedure for Standard Operating Procedure
Eudralex-The Rules Governing Medicinal Products in the European Union, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 16: Certification by a Qualified Person and Batch Release.