SOP for Testing and Release/Rejection of Packing Materials : Pharmaceutical Guidelines

SOP for Testing and Release/Rejection of Packing Materials

Standard operating procedure to teat and release or reject the analysed packing materials.


      To lay down the procedure for testing and release/rejection packing material.

2.0 SCOPE: 

      This SOP shall be applicable to Quality Control Dept.


      Quality Control Supervisor.


      Sr. Manager Quality Assurance


5.1 Records:

5.1.1 Proper records shall be maintained by Q.C Dept. showing details of the sample, the test protocol applied, results obtained, and the decision regarding acceptance/Rejection of the Material/ batch.
5.2 The details of the sample collected shall be entered into the entry register maintained separately for packing material.
5.3 The Packing material shall be tested as per the internal specifications and test procedures for the same.                    
5.4 A Report of the test protocol applied and results obtained shall be maintained in a proper format wherein the calculations/work sheet shall be included. Only one copy shall be made for packing material.
5.5 If the sample is found to be complying with the test specifications, the same shall be Approved/Released. If the same does not comply, the material shall be rejected. (Further procedure for rejected material shall be as per SOP for rejection material handling)
5.6 The Packing material shall be allotted "APPROVED” slips indicating Analytical Record Number and other relevant details, which shall be pasted on the material, and the consignment card shall be displayed showing the status of the batch.

Related: SOP for Disposal of Rejected Packing Material


6.1 SOP : Standard Operating Procedure
6.2 QC : Quality Control
6.3 Dept. : Department

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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