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SOP for Testing and Release / Rejection of Raw Material


Standard Operating Procedure to test and release the raw materials.

1.0 OBJECTIVE:

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

2.0 SCOPE: 

This SOP shall be applicable to Quality Control Dept.

3.0 RESPONSIBILITY:

Quality Control Supervisor

4.0 ACCOUNTABILITY:

Sr. Manager Quality Assurance

5.0 PROCEDURE: 

5.1 Records:
5.1.1 Proper records shall be maintained by Q.C Dept. showing the details of the sample, the test protocol applied, the results obtained, and the decision regarding acceptance/Rejection of the Material/Products.
5.2 The details of the sample collected shall be entered into the entry register maintained separately for raw material.
5.3 The Raw material shall be tested as per the relevant Monograph of the Pharmacopoeia applicable. If material is non-pharmacopoeial, same shall be tested as per In house specifications 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. Two copies of Test reports shall be made for raw materials.
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 raw material shall be Allotted the “APPROVED SLIP” having AR Number along with other relevant details, which shall be pasted on the material. The Finished goods shall be allotted the “RELEASE SLIP” having AR Number along with other relevant details, and the Consignment cards shall be displayed showing the status of the material/batch.
5.7 A copy of the Test Report of Finished product shall be attached along with the Batch Manufacturing Record.

6.0 ABBREVIATIONS:

6.1 SOP : STANDARD OPERATING PROCEDURE
6.2 QA : QUALITY ASSURANCE
6.3 QC : QUALITY CONTROL
6.4 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.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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