- OBJECTIVE:
To lay down a standard procedure to describe the steps to be followed for stage-wise yield calculation and final batch reconciliation.
- SCOPE:
This SOP is applicable to following dosage forms:
- Tablets
- Hard Gelatin Capsules
- RESPONSIBILITY:
3.1 Production supervisor, Packing supervisor, Production manager, Shift in-charge
- ACCOUNTABILITY:
4.1 QA Head, Production Head shall be accountable for compliance of this SOP.
- ATTACHMENTS:
Not applicable
- PROCEDURE:
6.1 General instructions
6.1.1 Actual average weight of tablets / capsule is the average of average weights observed during in-process checks at compression / filling stage.
6.1.2 Actual average weight of coated tablet is the average of 100 tablets.
6.1.3 At granulation / blending stage number of tablets / capsules shall be calculated based on the theoretical average weight.
6.1.4 At compression / filling, coating, imprinting and packaging stage number of tablets / capsules shall be calculated based on actual average weight of tablets / capsules.
6.1.5 For calculation of yield at granulation stage quantities in Kg shall be used and for calculation of yield at compression / filling, coating, imprinting, inspection and packing quantities of tablets / capsules shall be used in numbers.
6.1.6 Reprocessible recovery can be generated from export batch but will not be added in export batches. RR generated from export batches can be consumed in domestic batches, if formulation is similar.
6.2 Batch reconciliation record is a part of Batch Packing Record.
6.3 Yield calculation at granulation stage.
6.3.1 After completion of granulation, enter such details like Theoretical batch size, quantity of RR added, if any, in the batch.
6.3.2 Add theoretical batch size and RR quantity to get the revised theoretical batch size.
6.3.3 Mention theoretical average weight of tablets/capsule.
6.3.4 Mention actual net weight of the granules after completion of granulation.
6.3.5 Mention sample quantity (QC sample, validation sample or any other sample).
6.3.6 Mention rejects (non-recoverable quantity).
6.3.7 Calculate % yield using below given formula. Mention the yield limit in the space given in the form from the BMR of the batch. If yield is out of limit, fill in the deviation form.
Actual weight of granules (kg)
% Yield = ————————————————– x 100
Revised Theoretical Batch Size (kg)
6.3.8 Person who does the calculation shall sign/date in “Done by” column and granulation – in-charge who checks the calculation shall sign / date in “Checked by” column. IPQA person shall sign/date in ‘‘Counterchecked” by column.
6.3.9 If batch is for common blend of two or more strengths, complete the yield calculation of granulation stage and attach with BMR of common blend and reference Batch no. shall be specified in the reconciliation sheet issued for different product strengths.
6.4 Yield calculation at compression / filling stage
6.4.1 After completion of compression / filling, enter revised theoretical batch size in batch reconciliation record of Batch manufacturing record.
6.4.2 Mention actual average weight of tablet / capsule. Actual average weight shall be used to convert the net weight in Kg into numbers.
6.4.3 Mention actual net weight of the granules.
6.4.4 Pass the tablets through metal detector, if required and mention the inspected quantity in the given column.
6.4.5 Mention in process sample quantity, QC sample quantity and other sample quantity in the respective column. Add all sample quantities to get total sample quantity.
6.4.6 Mention recoverable recovery (RR) quantity, rejects non-recoverable quantity in the respective columns.
6.4.7 Calculate % Yield at compression / filling stage using below given formula. Mention the yield limit in the space given in the form from the BMR of batch. If yield is out of limit, fill in the deviation form.
Actual Quantity of product (No.) + sample Qty (No.)
% Yield = —————————————————————– x 100
(Compression/Filling stage) Actual Quantity of granules received (No.)
6.4.8 Calculate % Batch Yield up to compression/Filling stage using below given formula. Mention the yield limit in the space given in the form from the BMR of batch. If yield is out of limit, write justification in BMR at the space provided.
Actual Quantity of product (No.) + sample Qty (No.)
% Batch Yield = ————————————————————– x 100
Revised Theoretical Batch size (No.)
6.4.9 Person who does the calculation shall sign/date in Done by column and section -in-charge who checks the calculation shall sign / date in checked by column.
6.5 Yield calculation at coating / inspection stage
6.5.1 After completion of coating / inspection, enter good coated tablets / inspected tablets or capsules in batch reconciliation record in BMR.
6.5.2 Mention actual average weight of coated tablet / capsule. Actual average weight shall be used to convert the weight in Kg into numbers.
6.5.3 Mention in process sample quantity, QC sample quantity and other sample quantity in the respective column. Add all sample quantities to get total sample quantity.
6.5.4 Mention recoverable recovery (RR) quantity, Rejects Non-recoverable quantity in the respective columns.
6.5.5 Calculate % Yield at coating/inspection stage using below given formula. Mention the yield limit in the space given in the form from the BMR of batch. If yield is out of limit, write justification in BMR at the space provided.
Actual Quantity of product (No.) + Sample Qty (No.)
% Yield = —————————————————————– x 100
Actual Quantity of compressed tablet received
6.5.6 Calculate % yield up to imprinting/inspection stage using below given formula. Mention the yield limit in the space given in the form from the BMR of batch. If yield is out of limit, write justification in BMR at the space provided.
Actual Quantity of product (No.) + Sample Qty (No.)
% Batch Yield = ————————————————————————– x 100
(up to coating/Inspection stage) Revised Theoretical Batch size (No.)
6.5.7 Person who does the calculation shall sign/date in Done by column and section –in-charge who checks the calculation shall sign / date in checked by column.
6.6 Yield calculation at Imprinting / Inspection stage
6.6.1 After completion of imprinting / inspection, enter good tablets / inspected tablets or capsules in batch reconciliation record of BMR.
6.6.2 Mention actual average weight of tablet / capsule. Actual average weight shall be used to convert the net weight in Kg into numbers.
6.6.3 Mention in process sample quantity, QC sample quantity and other sample quantity in the respective column. Add all sample quantities to get total sample quantity.
6.6.4 Mention recoverable recovery (RR) quantity, Rejects Non-recoverable quantity in the respective columns of individual packs.
6.6.5 Calculate % yield at imprinting/inspection stage using below given formula. Mention the yield limit in the space given in the form from the BMR of batch. If yield is out of limit, write justification in BMR at the space provided.
Actual Quantity of product (No.) + Sample Qty (No.)
% Yield = —————————————————————- x 100
Actual Quantity of coated tablet/capsule received (No.)
6.6.6 Calculate % yield up to imprinting/inspection stage using below given formula. Mention the yield limit in the space given in the form from the BMR of batch. If yield is out of limit, write justification in BMR at the space provided.
Actual Quantity of product (No.) + Sample Qty (No.)
% Batch Yield = —————————————————————- x 100
Theoretical Batch size (No.)
6.6.7 Person who does the calculation shall sign/date in Done by column and section – in-charge who checks the calculation shall sign / date in checked by column.
6.7 Packing stage
6.7.1 Check the net weight of the product received for packing and enter in the batch reconciliation form.
6.7.2 Mention actual average weight of tablet / capsule. Actual average weight shall be used to convert the weight in Kg into numbers.
6.7.3 If batch is to be packed for 2 or more different markets / different pack styles, bifurcate the batch and mention the quantities in columns given. Convert the product quantities into numbers using actual weight of the product.
6.7.4 Mention in process sample quantity (e.g. Leak Test), QC sample quantity (e.g. Finished Product sample, Control sample), stability sample and other sample quantity in the respective column. Add all sample quantities to get total sample quantity for individual pack style.
6.7.5 Calculate % packing yield for individual pack style using below given formula. Mention the yield limit in the space given in the form from the BPR of batch. If yield is out of limit, write justification in BPR at the space provided.
Actual Quantity of product (No.) + Sample Qty (No.)
% Yield = ———————————————————————— x 100
Actual quantity of product received for individual pack (No.)
6.7.6 Person who does the calculation shall sign/date in Done by column and section –in-charge who checks the calculation shall sign / date in checked by column.
6.7.7 Add all packed quantities of various pack styles to get total packed quantities.
6.7.8 Add all sampled quantities of various manufacturing stage and packing stage to get total sampled quantities.
Note: In case of common blend, sample quantity at granulation stage will not be accounted for reconciliation.
6.7.9 Add all reprocessible recovery of various manufacturing stages and packing stage to get total reprocessible recovery quantities.
6.7.10 Add all process loss /rejects of various manufacturing stages and packing stage to get total process loss/ rejects quantities.
6.7.11 Calculate % yield of the Batch using below given formula. Mention the yield limit in the space given in the form from the BPR of batch. If yield is out of limit, write justification in BPR at the space provided.
Total packed Quantities (No.) + Total Sample Qty (No.)
% Batch Yield = ——————————————————————— x 100
Revised Theoretical Batch size (No.)
6.7.12 Calculate % Batch Reconciliation of the Batch using below given formula. Mention the limit given in BPR of the batch in the space provided. If yield is out of limit, write justification in BPR at the space provided.
Total packed Quantities (No.) + Total Sample Qty (No.)+ Total
Process loss / Rejects (No.) + Total Reprocessible Recovery (No.)
% Batch reconciliation = ———————————————————————————-x 100
Revised Theoretical Batch size (No.)
6.7.13 Person who does the calculation shall sign/date in Done by column, packing –in-charge who checks the calculation shall sign / date in checked by column and QA person who verifies the calculation shall sign / date in verified by column.
- REFERENCES:
In-House
- ABBREVIATIONS:
QC: Quality Control
QA: Quality Assurance
BMR: Batch Manufacturing Record
BPR: Batch Packing Record
SOP: Standard operating procedure
RR: Reprocessible Recovery
9.0 DISTRIBUTUON LIST:
Quality Assurance
Production
10.0 HISTORY OF REVISION:
| Version No. | Effective Date | Reason for Revision |
