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SOP For Sampling of Packing Material

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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

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