Scribd
Upload
644 views3 pages

SOP For Sampling of Packing Material

This 3 page standard operating procedure describes the sampling of packing material for liquids, tablets, and capsules. It outlines that the quality control supervisor is responsible for following the sampling procedure, while the quality assurance manager ensures compliance. For liquids, samples should be taken from the beginning, middle, and end of the packing process. For tablets and capsules, final samples should also be taken at the initial, middle, and final stages of blistering, stripping, or packing. The quantity sampled should allow for complete analysis of the product at least twice.

Uploaded by

Solomon
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
644 views3 pages

SOP For Sampling of Packing Material

This 3 page standard operating procedure describes the sampling of packing material for liquids, tablets, and capsules. It outlines that the quality control supervisor is responsible for following the sampling procedure, while the quality assurance manager ensures compliance. For liquids, samples should be taken from the beginning, middle, and end of the packing process. For tablets and capsules, final samples should also be taken at the initial, middle, and final stages of blistering, stripping, or packing. The quantity sampled should allow for complete analysis of the product at least twice.

Uploaded by

Solomon
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/ 3

Issue No.

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

Checked by： Y Y
Department Name Date

Approved by： Z Z
Department Name Date
Issue No.
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 Validity

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

3. Responsibility

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

4. 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:
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.
Issue No.
1
Title:
Document No: Page No.
SOP/QC/049 SOP for Sampling of Packing Material Page 3 of 3

Effective Date Revision Date

6.2.2 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.

Related: Procedure for Line Clearance Before Commencing any Manufacturing Operation

You might also like