Procedure for calculating reconciliation and yield during the manufacturing and packaging of the drug products.

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