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SOP For Sampling of Packing Material

This document outlines the Standard Operating Procedure (SOP) for sampling packing materials at Humanwell Pharmaceutical Ethiopia PLC, specifically for finished products like liquids, tablets, and capsules. It defines responsibilities, procedures for sampling at various stages of packing, and emphasizes compliance by the Quality Control department. The SOP is valid until the next revision and requires samples to be collected at initial, middle, and final stages of the packing process.

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Solomon Gamanuel
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4 views3 pages

SOP For Sampling of Packing Material

This document outlines the Standard Operating Procedure (SOP) for sampling packing materials at Humanwell Pharmaceutical Ethiopia PLC, specifically for finished products like liquids, tablets, and capsules. It defines responsibilities, procedures for sampling at various stages of packing, and emphasizes compliance by the Quality Control department. The SOP is valid until the next revision and requires samples to be collected at initial, middle, and final stages of the packing process.

Uploaded by

Solomon Gamanuel
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
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Company Name:: Version

No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No: Page No.
SOP/QC/049 SOP for Sampling of Packing Material Page 1 of 3

Effective Date Revision Date

SOP for Sampling of Packing Material

Prepared by： X X
Department Name Date

Approved by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date
Company Name:: Version
No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No: Page No.
SOP/QC/049 SOP for Sampling of Packing Material Page 2 of 3

Effective Date Revision Date

1. Purpose
This procedure defines the procedure of sampling of finished products - Liquids Orals, Tablet
and Capsules

2. Scope

This procedure is applicable for Quality Control Dept in Humanwell Pharmaceutical Ethiopia
PLC .

3. Validity

This SOP is valid only until next revision date and if it bears control seal.

4. Responsibility

It will be the responsibility of the Quality Control supervisor to follow the procedure.
Quality assurance manager is responsible for SOP compliance.

5. Material and Equipment

None
6. Procedure:

6.1. For Liquids Orals:


6.1.1. The Packing department shall inform the start of packing operations of the batch to QA
person.
6.1.2. The QA person shall collect the sample from the packing line.
6.1.3. The quantity of the sample shall be such as to enable complete analysis of product at least
twice.
6.1.4. Sampling of products for analysis, from the packing section shall be as per master
document.
6.1.5. Collect the sample on initial, middle and final stage of packing operation.
6.2. For Tablets/Capsules:
Company Name:: Version
No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No: Page No.
SOP/QC/049 SOP for Sampling of Packing Material Page 3 of 3

Effective Date Revision Date

6.2.1 Final sample for the Finished product shall be collected on initial, middle and final
stage of blistering / stripping / packing by QA person.
6.2.2 Sampling of products for analysis, from the packing section shall be as per master
document.
6.2.3 Finished Product sampling should be done online as required in the product
specification, preferably after approximately 50% of bulk is packed.

7. Abbreviations

SOP: Standard Operating Procedure


8. Related Documents /Applicable document/

None

9. Revision History

Version
Revision Description
No.

1 New

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