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Sop Qa 066

The document describes the procedure for calculating reconciliation and yield during batch manufacturing and packaging. It provides the formulas and specifications for calculating reconciliation and yield at different stages like granulation, compression and packaging.

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chalicevitalchem
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32 views2 pages

Sop Qa 066

The document describes the procedure for calculating reconciliation and yield during batch manufacturing and packaging. It provides the formulas and specifications for calculating reconciliation and yield at different stages like granulation, compression and packaging.

Uploaded by

chalicevitalchem
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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CELEBRITY BIOPHARMA LIMITED

Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/01


STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/065/00
Version 00
Superseded SOP No. Nil
Calculation, Reconciliation and Yield
Title During the Batch Manufacturing and Effective Date
Packaging Review Date
Page Number 1 of 2

1. OBJECTIVE
1.1 To describe a procedure for calculation, reconciliation and yield of batches during the
manufacturing and packaging.
2. SCOPE
2.1 This procedure is applicable for calculation, reconciliation and yield of batch during the
manufacturing and packaging at production department of Celebrity Biopharma Limited.
3. 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. 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 100Qty. Issued
% Yield: Quantity physically produced or manufactured at the end of the operation.
% Yield = Qty. manufactured x 100
Qty. Issued (Batch Size)
Reconciliation and yield shall be calculated in percentage.
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%

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CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/01
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/065/00
Version 00
Superseded SOP No. Nil
Calculation, Reconciliation and Yield
Title During the Batch Manufacturing and Effective Date
Packaging Review Date
Page Number 2 of 2

5. REFERENCES
5.1 Nil
6. RECORDS
6.1 Nil

8. ABBREVIATIONS
8.1 SOP : Standard Operating Procedure
8.2 QA : Quality Assurance
8.3 QC : Quality Control
8.4 NLT : Not Less Than
8.5 Qty. : Quantity

9. REVISION RECORD
Version Reason for Revision Effective Date
00 New SOP -------

END OF DOCUMENT

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