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 Supervisor4.0 ACCOUNTABILITY
Sr. Manager Quality Assurance5.0 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 the 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/worksheet 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 the finished product shall be attached along with the Batch Manufacturing Record.
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure6.2 QA: Quality Assurance
6.3 QC: Quality Control
6.4 Dept.: Department
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