PURPOSE
To provide the procedure for calculating reconciliation and yield during the manufacturing and packaging of the drug products.
SCOPE
This procedure is applicable to the Reconciliation of Component and finished Products manufactured at XYZ Ltd.
RESPONSIBILITY
Manufacturing and packaging personnel are responsible for calculation of the yield and reconciliation.
QA personnel (IPQC) are responsible for verifying the calculation and authorizing the rejected quantity.
PROCEDURE
- The purpose of reconciliation is to ensure that all materials have been accounted for and no mix-up occurred. Reconciliation is carried out on printed and/or coded components and the finished product.
- The reconciliation shall help detect errors at the time of manufacture and avoid the release of a non-conforming product.
- % Reconciliation: Accounting of the material used in the manufacturing and packaging.
- The formula is
- % Yield: Quantity physically produced or manufactured at the end of the operation.
- Reconciliation and yield shall be calculated in percentage and fill as mention in (appendix -1 ).
- The specification for reconciliation and yield calculation is as follows:
|
Stage (At the end of stage) |
Yield |
|
Granulation
/ Preparation |
NLT 98 % |
|
Compression
/ Filling |
NLT 98 % |
|
Coating
|
NLT 99 % |
|
Blistering
/ packaging |
NLT 98 % |
- Yields outside the set tolerances must be explained in a Deviation Report
ANNEXURE
ABBREVIATIONS
SOP : Standard Operating Procedures.
cGMP : current Good Manufacturing Practice.
Qty : Quantity .
IPC : In process Checks
REVISION HISTORY
Nil
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