1.0.
OBJECTIVE:
To
provide procedure for calculating reconciliation and yield during the
manufacturing and packaging of the drug products.
2.0.
SCOPE:
This
procedure is applicable for calculation of the % reconciliation and % yield of
the drug products.
3.0.
RESPONSIBILITY:
3.1.
Manufacturing and
packaging personnel are responsible for calculation of the yield and reconciliation.
3.2.
QA personnel are
responsible for verifying the calculation.
4.0.
PROCEDURE:
4.1.
% Reconciliation: Accounting of the material used in the
manufacturing and packaging.
4.2.
The formula is
%
Reconciliation = Qty. Used + Qty. Returned + Samples + Others x 100
Qty.
Issued
4.3.
% Yield: Quantity
physically produced or manufactured at the end of the operation.
%
Yield = Qty. manufactured x 100
Qty. Issued (Batch Size)
4.4.
Reconciliation and
yield shall be calculated in percentage.
4.5.
The specification for
reconciliation and yield calculation is as follow:
|
Stage
(At
the end of the stage)
|
% Yield
|
|
Granulation
|
NLT 98%
|
|
Compression
|
NLT 96.5%
|
|
Packaging
|
NLT 96.00%
|
5.0.
ANNEXURE:
Nil
6.0.
REFERENCES:
7.0.
ABBREVIATION :
Abbreviation used Full form of abbreviation used
SOP Standard
Operating Procedure
QA Quality
Assurance
QAD Quality
Assurance Department
QTY Quantity
% Percentage
8.0.
DISTRIBUTED TO:
Quality Assurance
Manufacturing
9.0.
REVISION HISTORY:
|
Revision
|
Change
Control Number
|
Reason
for the Modifications
|
|
|
|
|
