Standard Operating Procedure of Sampling and Release of in Process Samples is describe in this post.
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Title: Standard operating procedure of sampling and release of in-process samples as tablets, capsule, powder and liquid samples.
1.0 OBJECTIVE:
To lay down a procedure for sampling and release of in-process samples.
2.0 SCOPE:
This SOP shall be applicable to quality control and quality assurance dept.
3.0 RESPONSIBILITY:
3.1 Quality Assurance Supervisor.
3.2 Quality Control Supervisor.
4.0 ACCOUNTABILITY:
4.1 Sr. Manager Quality Assurance.
4.2 Head of the Department.
5.0 PROCEDURE:
5.1 Liquid-Sampling:
5.1.1 Bulk sample-After completion of a particular manufacturing step, the production department shall intimate Q.A dept. through the bulk sample intimation slip and test request form.
5.1.2 Q.A personnel shall sample from the bulk storage tank after receiving the intimation and shall fill up all the batch details in this test request form and sent it to Q.C dept.
5.1.3 Q.A personnel shall sample from top & bottom (if available) and the composite quantity shall be as per product requirement.
5.1.4 Q.A personnel shall also sample the validation batches and the sampling pattern shall be as per the individual protocol.
5.2 Liquid-Release:
5.2.1 The Q.C dept. shall analyze the sample for the respective actives and then hand over a green color released tag to Q.A personnel, who in turn shall paste it in the BMR.
5.3 Tablet/ Capsule/ Powder-Sampling:
5.3.1 After completion of a particular manufacturing step i.e. Blending (if required) compression/ coating/ filling, the production dept. shall intimate Q.A. dept. through the test request form for sampling.
5.3.2 Q.A personnel shall sample from container/ equipment in which the process has taken place after receiving the intimation and shall fill up all the batch details in the test request form and sent it to Q.C dept.
5.3.3 In case of compressed tablets/ capsule filling, Q.A personnel shall sample during initial, middle and final of the cycle and then send the composite sample for analysis.
5.4 Tablet/ Capsule/ Powder-Release:
5.4.1 The Q.C dept. shall analyze the sample for the respective actives and then hand over a green color released tag to:
5.4.1.1 Q.A personnel who in turn shall paste it on the BMR.
5.4.1.2 Q.A personnel shall also sample the validation batches and the sampling pattern shall be as per the individual protocol.
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