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Calculation of Yield Procedure

This document provides a procedure for calculating the percentage reconciliation and yield of drug products during manufacturing and packaging. It assigns responsibilities to manufacturing, packaging, and quality control personnel and references regulatory requirements. Key terms are defined, such as reconciliation, yield, and percentage. The procedure explains how to calculate reconciliation as a percentage of materials used versus issued and yield as a percentage of the quantity manufactured versus the batch size. Specifications for minimum reconciliation and yield percentages are given.

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563 views2 pages

Calculation of Yield Procedure

This document provides a procedure for calculating the percentage reconciliation and yield of drug products during manufacturing and packaging. It assigns responsibilities to manufacturing, packaging, and quality control personnel and references regulatory requirements. Key terms are defined, such as reconciliation, yield, and percentage. The procedure explains how to calculate reconciliation as a percentage of materials used versus issued and yield as a percentage of the quantity manufactured versus the batch size. Specifications for minimum reconciliation and yield percentages are given.

Uploaded by

Anonymous AfAbnY
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Minimally Invasive Therapies Group (MITG)

DOC. TITLE: Calculation of Yield


DOCUMENT NO:
|
DOC. CAT:

REVISION:

1. SCOPE
1.1This procedure is applicable for calculation of the % reconciliation and
% yield of the drug products

2. PURPOSE
2.1.
To provide procedure for calculating reconciliation and yield
during the manufacturing and packaging of the drug products

3. RESPONSIBILITIES
3.1.
Manufacturing and packaging personnel are responsible for
calculation of the yield and reconciliation
3.2.

QC personnel are responsible for verifying the calculation.

4. REFERENCES
4.1.

21 CFR 211.103 Calculation of Yield

5. DEFINITIONS
5.1.
QC
Quality Control
5.2.
QCD Quality Control Department
5.3.
QTY Quantity
5.4.
%
Percentage
5.5.
NLT Not Less than
5.6.
Yield The quantity that is actually produced at any phase of
production of a particular
drug product based on the initial input.

6. PROCEDURE
6.1 % Reconciliation: Accounting of the material used in the
manufacturing and packaging
6.2 The formula is:
% Reconciliation = Qty. Used + Qty. Returned + Samples + Others
(scrap) x 100
Qty. Issued
6.3

% Yield:

CONFIDENTIAL INFORMATION

SHEET 1 OF 2

DOCUMENT NO:

REVISION:

Quantity physically produced or manufactured at the end of the


operation.
% Yield =

Qty. manufactured x 100


Qty. Issued (Batch Size)

6.4 Reconciliation and yield shall be calculated in percentages


6.5 The specification for reconciliation and yield calculation is as follows
Stage

% Yield
NLT %
NLT %
NLT %

REASON FOR DOCUMENT REVISION


New Document

CONFIDENTIAL INFORMATION

SHEET 2 OF 2

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