sop for sampling and release of inprocess samples pharmace
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APR 29, 2008
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SOP for Sampling and Release of Inprocess SamplesCATEGORIES: QUALITY ASSURANCE , QUALITY CONTROL , SOP
Standard operating procedure of sampling and release of in-process samples as tablet, capsule, powder and liquid oral 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 Supervisor4.0 ACCOUNTABILITY: Sr. Manager Quality Assurance5.0 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 departmentthrough 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 thistest 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 analyse the sample for the respective actives and then hand over a green color released tag to QualityAssurance 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 shallintimate 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 andshall 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 thensend the composite sample for analysis.5.4 Tablet /Capsule /Powder – Release :The Quality Control department shall analyse 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 Procedure6.2 QA : Quality Assurance6.3 QC : Quality Control6.4 Dept. : Department
SOP for Sampling and Release of Inprocess Samples : Pharmaceutical Guidelines 22/12/2013
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Further Reading:, ,
1. SOP for Cleaning of Semi-Automatic Cartoning Machine
2. SOP for Cleaning of Mini Roll Compactor
3. SOP for Cleaning of Tablet Counter
4. SOP for Cleaning of Semi Auto Induction Cap Sealing Machine
5. Recovery Factor and its Determination in Cleaning Validation
6. Process Validation Sample Protocol
7. Procedure for Sampling in Process Validation
8. Importance of Annual Product Quality Review (APQR/APR/PQR) in Quality Improvements
9. Organogram and Job Responsibilities in Pharmaceuticals
10. Relative Response Factor (RRF) and its Calculation in HPLC Analysis
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