SOP on handling of rinse and swab sample

SOP on handling of rinse and swab sample

1.0 Objective

1.1 To establish a procedure for the receipt, recording, analysis, and handling of rinse and swab samples in the Quality Control (QC) Department.

2.0 Scope

2.1 This SOP is applicable to the handling, documentation, and analysis of rinse and swab samples received in the Quality Control Department.

3.0 Responsibility

3.1 Chemist or Above – QC Department

• Responsible for receipt, recording, and analysis of rinse and swab samples as per approved procedures.

3.2 QC Executive / Nominee

• Responsible for allocation of samples for analysis and review of analytical results.

4.0 Accountability

4.1 Head – Quality Control

• Accountable for ensuring proper implementation of this SOP and final approval of analytical results.

5.0 Procedure

5.1 The In-Process Quality Assurance (IPQA) personnel shall collect rinse or swab samples and submit them to the Quality Control Department along with the Sample Intimation Slip as per Annexure , duly filled with all required details.

5.2 Upon receipt of the samples, the QC Chemist or above shall record the details of the rinse and swab samples in the Rinse and Swab Sample Inward Register as per Annexure.

5.3 The Analytical Request (A.R.) Number for the rinse and swab samples shall be generated as per SOP.

5.4 The QC Executive / Nominee shall allocate the samples to the concerned QC Chemist for analysis.

5.5 The QC Chemist shall perform the analysis according to the Standard Test Procedure (STP) of the respective product, and all raw data shall be recorded in the continuation sheets or relevant analytical worksheets.

5.6 After completion of analysis, the QC Executive / Nominee shall review the analytical results and forward the documents to the Head – QC for final approval.

5.7 After approval by the Head – QC, one signed copy of the Rinse and Swab Sample Intimation Slip shall be forwarded to the IPQA Department for record and reference.

5.8 If the results are found Out of Specification (OOS), the procedure defined in SOP No. QA-SG-031 – Handling, Investigation, and Reporting of Out of Specification Results shall be followed for necessary investigation and corrective actions.

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6.0 List of Annexures