SOP ON PROCEDURE FOR HANDLING OF BATCH BIFURCATION IN PHARMA
OBJECTIVE: To lay down the Procedure for Handling of Ready for Filling (Blend) and Ready for Packing (Tablets) and Batch Bifurcation for primary Packing Area.
SCOPE: This procedure is applicable for Handling of Ready for Filling (Blend) and Ready for Packing (Tablets) and Batch Bifurcation for primary Packing Area.
RESPONSIBILITY:
It is the responsibility of operator and production chemist to follow the procedure as prescribed in this SOP during storage of blend and tablets in quarantine area.
Officer Production/chemist or designee is responsible for execution of SOP and maintaining the records.
Manager/Executive or designee of Production department is responsible for giving the training on regarding tasks and review the related records.
ACCOUNTABILITY: Head – Production Department.
PROCEDURE:
Definitions:
Batch Number:A distinctive combination of numbers and/or letters which specifically identifies a batch on the labels, the batch records, and the certificates of analysis, etc.
Mother Batch:A product that has completed all processing stages up to, but not including, final packaging.
Child Batch: From the Mother Batch (After complete manufacturing) Packing shall be done in one or more pack style/party(s) and it is called Child Batch.
For Dry Syrup Filling:
After blending and sampling blended material shall be weighing and kept into the double lined poly bag in HDPE containers.
After receiving of QC release for the blend stage of dry syrup batch, blend material is ready for filling in HDPE and Glass bottles as per party’s requirement.
If one mother batch shall be packed in single child batch then batch bifurcation is not required and child batch number is the same as mother batch number or as per party specific batch number.
If one mother batch shall be packed in two or more child batches then batch bifurcation is required and child batch number will be changed from the mother batch number
As per SOP of Batch Numbering System A, B, C, D ……. etc. shall be suffixed to the mother batch number. For example: Mother batch No. is CD24001 and this batch shall be packed in two child batches then Child batch No. shall be as CD22001A andCD24001B
Child batch number shall also be changed as per party specific batch numbering system.
Required containers of blended material from mother batch shall be issued for powder filling process of a child batch as per their required batch size.
After filling the desired number of bottles as shown in the filling machine counter, filling shall be stopped and prepare for the next child batch filling as per batch bifurcation planning.
At the end of shift for the day check the counter and tightly close the remaining powder in double lined polybags and seal the HDPE container properly and send back to the respective quarantine area with inward entry in the logbook.
Next day again issue the remaining quantity of child batch and make outward entry in the respective logbook and then start the filling process and complete the batch filling.
For example one mother batch i.e. CD24001 of Total batch size: 30,000 Bottles, 12gm average fill weight, shall be packed into two child batches of CD24001A : 10,000 Bottles and CD24001B : 20,000 Bottles as per batch planning, then blended powder’s intact containers as per average fill weight (12gm per bottle) and desired batch size of child batch No. CD24001A (10,000 Bottles)
If approximately 25 Kg. powder kept in one container, then 25 Kg. x 5 HDPE containers shall be issued for powder filling process for child batch No. CD24001A (10,000 Bottles).
Start the bottle filling process and check the bottle filling counter on filling machine, when desired filling quantity have been achieved in the counter then immediately stop the filling machine.
If next child batch is planned on the same day in continuation then remaining containers of blended powder from the quarantine area shall be issued for next batch and make entry in outward logbook and fill the bottles of next child batch with following the respective SOPs.
But if next child batch is planned on next day then close the remaining powder in HDPE container and return to the respective quarantine are and make entry in inward logbook.
Note: Cephalosporin and Penicillin drugs are highly sensitive for temperature and relative humidity; hence continue powder filling for multiple child batches is permitted from the same mother batch. There is no need to frequent inward and outward from quarantine to filling area for batch to batch if filling process is done continue on same day, however on shift end inward and outward shall be done as per respective SOP.
Please ensure the powder is tightly closed in double lined polybags in controlled temperature and relative humidity with removal of excess air from the polybags and silica gel pouch shall be kept in between polybags and HDPE container then close the HDPE lid and close it by stretchable poly film roll to eliminate risk of moisture.
For Uncoated & Coated Tablet Packing:
Dispersible, Uncoated and Coated Tablets shall be covered in this procedure.
After completion of tablet compression, compressed tablets are ready for tablet inspection (Dispersible and Uncoated Tablets).
After completion of tablet coating, coated tablets are ready for tablet inspection (Coated Tablets).
After receiving of QC release for the compressed or coated stage, inspected tablets are ready for primary packing in Alu-Alu Blister Pack and Strip Pack as per party’s requirement)
If one mother batch shall be packed in single child batch then batch bifurcation is not required and child batch number is the same as mother batch number or as per party specific batch number.
If one mother batch shall be packed in two or more child batches then batch bifurcation is required and child batch number will be changed from the mother batch number.
As per SOP of Batch Numbering System A, B, C, D ……. etc. shall be suffixed to the mother batch number. For example: Mother batch No. is CT24001 and this batch shall be packed in two child batches then Child batch No. shall be as CT22001A andCT24001B
Child batch number shall also be changed as per party specific batch numbering system.
Required containers of Inspected Tablets from mother batch shall be issued for primary packing of a child batch as per their required batch size.
After primary packing (Alu-Alu or Strip Pack) the desired number of packed tablets as shown in the packing machine counter, packing shall be stopped and prepare for the next child batch packing as per batch bifurcation planning.
At the end of shift for the day check the counter and tightly close the remaining tablets in double lined polybags and seal the HDPE container properly and send back to the respective quarantine area with inward entry in the logbook.
Next day again issue the remaining quantity of child batch and make outward entry in the respective logbook and then start the primary packing process and complete the batch packing.
For example one mother batch i.e. CT24001 of Total batch size: 5,00,000 Tablets, 1050mg average weight of the tablet, shall be packed into two child batches of CT24001A : 2,50,000 Tablets and CT24001B : 2,50,000 Tablets as per batch planning, then Inspected Tablets’s intact containers as per average weight of tablet (1050mg per tablet) and desired batch size of child batch No. CT24001A (2,50,000 Tablets)
If approximately 25 Kg. tablets kept in one container, then 25 Kg. x 11 HDPE containers shall be issued for primary packing for child batch No. CT24001A (2,50,000 Tablets).
Start the primary packing and check the packed tablets counter on packing machine (Alu-Alu or Strip Pack), when desired packing quantity have been achieved in the counter then immediately stop the packing machine.
If next child batch is planned on the same day in continuation then remaining containers of tablets from the quarantine area shall be issued for next batch and make entry in outward logbook and pack the tablets of next child batch with following the respective SOPs.
But if next child batch is planned on next day then close the remaining tablets in HDPE container and return to the respective quarantine are and make entry in inward logbook.
Note: Cephalosporin and Penicillin drugs are highly sensitive for temperature and relative humidity; hence continue primary packing for multiple child batches is permitted from the same mother batch. There is no need to frequent inward and outward from quarantine to filling area for batch to batch if primary packing process is done continue on same day, however on shift end inward and outward shall be done as per respective SOP.
Please ensure the tablets are tightly closed in double lined polybags in controlled temperature and relative humidity with removal of excess air from the polybags and silica gel pouch shall be kept in between polybags and HDPE container then close the HDPE lid and close it by stretchable poly film roll to eliminate risk of moisture.
For batch bifurcation recording, “Batch Bifurcation Form” as per Annexure-1 shall be filled and attach in the mother batch manufacturing record (BMR).
ENCLOSURE
BATCH BIFURCATION FORM
