SOP for Sampling and Release of Inprocess Samples

1.0 OBJECTIVE

To lay down the 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

Quality Assurance Supervisor & Quality Control Supervisor

4.0 ACCOUNTABILITY

Sr. Manager Quality Assurance

5.0 PROCEDURE

5.1 Liquid Oral – Sampling

5.1.1 Bulk sample – After completion of a particular manufacturing step, the production department shall intimate Quality Assurance department through the bulk sample intimation slip and the test request form.
5.1.2 Quality Assurance 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 Quality Control department.
5.1.3 Quality Assurance personnel shall sample from Top & Bottom (if available) and the composite quantity shall be as per product requirement.
5.1.4 Quality Assurance personnel shall also sample the validation batches and the sampling pattern shall be as per the individual protocol.

5.2 Liquid Oral – Release

5.2.1 The Quality Control department shall analyze the sample for the respective actives and then hand over a green color released tag to Quality Assurance personnel, who in turn shall paste it in the batch manufacturing record.

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 department shall intimate Quality Assurance department through the Test request form for sampling.
5.3.1 Quality Assurance 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 Quality Control department.
5.3.2 In case of Compressed tablets / Capsule filling, quality assurance 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

The Quality Control department shall analyze the sample for the respective actives and then hand over a green color released tag to quality.
5.4.1 Assurance personnel who in turn shall paste it on the batch manufacturing record.
5.4.2 Quality Assurance personnel shall also sample the validation batches and the sampling pattern shall be as per the individual protocol.

6.0 ABBREVIATIONS

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

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