Scribd
Upload
2K views4 pages

Reconciliation SOP NEW

This document provides a standard operating procedure for calculating reconciliation and yield during manufacturing and packaging of drug products. It outlines the purpose, scope, references, abbreviations, procedures, responsibilities, and document revision history. The procedure describes how to calculate reconciliation and yield percentages at different stages of production and specifies target yields of 98% or higher for most stages.

Uploaded by

Prince Moni
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
2K views4 pages

Reconciliation SOP NEW

This document provides a standard operating procedure for calculating reconciliation and yield during manufacturing and packaging of drug products. It outlines the purpose, scope, references, abbreviations, procedures, responsibilities, and document revision history. The procedure describes how to calculate reconciliation and yield percentages at different stages of production and specifies target yields of 98% or higher for most stages.

Uploaded by

Prince Moni
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 4

SOP for calculating reconciliation and yield during

the manufacturing and packaging


REVISION DATE: 3 years after effective date or when needed.

TABLE OF CONTENTS:

1-HISTORY………………………………………………………………………......2

2-PURPOSE…………………………………………………………………………..2

3- SCOPE……………………………………………………………………………..2

4-REFERENCE………………………………………………………………………2

5-ABBREVIATIONS AND DEFINITIONS ………………………………..……....2

6-PROCEDURE……………………………………………………………..…….....3

7-RESPONSIBILTIES………………………………………………………………5

8-DOCUMENTS REVISION………………………………………………….........5

1- HISTORY:
This is the first SOP .

2- PURPOSE:
To provide procedure for calculating reconciliation and yield during the manufacturing and packaging
of the drug products.
3- SCOPE:
This procedure is applicable to Reconciliation of Component and finished Products manufactured at MDI
company .

4- REFERENCES:
MDI own generated SOP.

5- ABBREVIATIONS AND DEFINITIONS:


 (SOP) Standard Operating Procedures.
 (cGMP) current Good Manufacturing Practice.
 (Qty) Quantity .
 (IPC ) In process Checks .

6- PROCEDURE:
6.1. 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.
Reconciliation shall help detect errors at the time of manufacture and avoid release of a non-conforming
product.
6.2. % Reconciliation: Accounting of the material used in the manufacturing and packaging.

6.3. The formula is


% Reconciliation = Qty. Used + Qty. Returned + Samples + Others x 100
Qty. Issued
6.4. % Yield: Quantity physically produced or manufactured at the end of the operation.

% Yield = Qty. manufactured x 100


Qty. Issued (Batch Size)
6.5. Reconciliation and yield shall be calculated in percentage and fill as mention in
(appendix -1 ) .
6.6. The specification for reconciliation and yield calculation is as follow:

Stage
Yield
( At the end of stage )
Granulation / Preparation NLT 98 %

Compression / Filling NLT 98 %

Coating NLT 99 %

Blistering / packaging NLT 98 %

6.7. Yields outside the set tolerances must be explained in a Deviation Report .

7- RESPONSIBILITY:
7.1. Manufacturing and packaging personnel are responsible for calculation of the yield and
reconciliation.

7.2. QA personnel ( IPC ) are responsible for verifying the calculation and authorizing the
rejected quantity.

8- DOCUMENTS REVISION:

No. Section Pages Initials/Date


1
2
3
4

END OF DOCUMENT

ATTACHMENTS:

batch reconciliation and yield . ( Appendix – 1)


SOP # QA- 022 Appendix – 1
Batch reconciliation and yield

Product Name : Batch No.:


Mfg. Date : / 20 Exp. Date : / 20 Starting Date : / / 20
Department : Stage :
Type of material :

Theoretical Actual Sampled Returned Containers


Date Other
Quantity Quantity Quantity Quantity Number

Qty. used + Qty. Returned + Samples + Others


% Reconciliation = ‫ ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ‬x100
Qty. Issued

% Reconciliation = ‫ ـــــــــــــــــــــــــــــــــــــــــ ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ‬x100

% Reconciliation =

Actual Qty.
Yield % = ‫ ــــــــــــــــــــــــــــــــــــــــــــــــــــــ‬x100
Theoretical Qty.

Yield % = ‫ ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ‬x100

Yield % =

Specification for :
Granulation / preparation : NLT 98 %
Compression / Filling : NLT 98%
Coating NLT 99 %
Blistering / Packaging : NLT 98 %
Packaging material NLT 99 %

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy