SOP for Calculating Yield and Reconciliation

PURPOSE

To provide the procedure for calculating reconciliation and yield during the manufacturing and packaging of the drug products.

SCOPE

This procedure applies to the Reconciliation of Component and finished Products manufactured at PharmaInfo Ltd.

RESPONSIBILITY

Manufacturing and packaging personnel are responsible for the 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 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 mentioned in (appendix -1 ).
• The specification for reconciliation and yield calculation is as follows:

Stage (At the end of the 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

ALSO READ: SOP for Receipt of COA from QC