This document provides a procedure for calculating reconciliation and yield percentages during drug manufacturing and packaging. Reconciliation is calculated by accounting for all material used in production. Yield is the quantity of product physically produced, calculated as a percentage of the batch size. The procedure specifies acceptable yield percentages of at least 98% for granulation, 96.5% for compression, and 96% for packaging.
This document provides a procedure for calculating reconciliation and yield percentages during drug manufacturing and packaging. Reconciliation is calculated by accounting for all material used in production. Yield is the quantity of product physically produced, calculated as a percentage of the batch size. The procedure specifies acceptable yield percentages of at least 98% for granulation, 96.5% for compression, and 96% for packaging.
This document provides a procedure for calculating reconciliation and yield percentages during drug manufacturing and packaging. Reconciliation is calculated by accounting for all material used in production. Yield is the quantity of product physically produced, calculated as a percentage of the batch size. The procedure specifies acceptable yield percentages of at least 98% for granulation, 96.5% for compression, and 96% for packaging.
This document provides a procedure for calculating reconciliation and yield percentages during drug manufacturing and packaging. Reconciliation is calculated by accounting for all material used in production. Yield is the quantity of product physically produced, calculated as a percentage of the batch size. The procedure specifies acceptable yield percentages of at least 98% for granulation, 96.5% for compression, and 96% for packaging.
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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 % Yield (At the end of the stage) 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 Reason for the Modifications Number
