SOP Title: Analysis and Release of Semi Finished and Finished Products
- Objective:
To lay down the procedure for Analysis and Release of Semi Finished and Finished Products.
- Scope:
This procedure is applicable for Analysis and Release of Semi Finished and Finished Products in
Quality Control Department.
- Responsibility:
- Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Analysis and Release of Semi Finished and Finished Products in Quality Control Department as per this SOP.
- Quality Assurance Department: To review and approve the SOP and Annexures.
- Accountability:
Head Quality Control Department, Head Quality Assurance Department
- Procedure:
| 5.1 | Procedure for Analysis and Release of Finished products: | |
| 5.1.1 | Quality Assurance Personnel is responsible for sampling of finished products and Semi Finished products. | |
| 5.1.2 | On receipt of the Finished product sample, Supervisor/QC Head shall make entry in the ‘Finished Product Inward Register’. | |
| 5.1.3 | On receipt of the Semi Finished product sample, Supervisor/QC Head shall make entry in the ‘Semi Finished Product Inward Register’ | |
| 5.1.4 | Supervisor/QC Head shall allocate the Analytical reference Number
(A. R. No.) for the samples received as follows: |
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| 5.1.5 | Assign Analytical Reference Number for Finished Product as “FP/YY/NNN”
Where, ‘FP’ stands for ‘Finished Product’. ‘YY’ stands for ‘Last two digits of the current year’. ‘NNN’ stands for ‘Serial number’ i.e. 001, 002 and so on. |
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| 5.1.6 | Assign Analytical Reference Number for Semi Finished Product as “SF/YY/NNN”.
Where, ‘SF’ stands for ‘Semi Finished’. ‘YY’ stands for ‘Last two digits of the current year’. ‘NNN’ stands for ‘Serial number’ i.e. 001, 002 and so on |
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| 5.1.7 | Supervisor/QC Head shall allocate the testing samples to the analysts as per their job responsibility and specialisation. | |
| 5.1.8 | Analyst should refer standard testing procedure before initiating the testing. | |
| 5.1.9 | Analyst should give requisition for “Analytical Work Report” to the Quality Assurance Department as per the SOP. | |
| 5.1.10 | Analyst should refer standard testing procedure to ensure that all required reagents, chemicals, accessories, equipment or instruments are standardised or validated and available in the laboratory. | |
| 5.1.11 | In case of non availability of chemicals, impurities, working standard, instruments or equipments in the laboratory for any specified test then the sample to be send to Government approved outside testing laboratory, by filling “Requisition for Analysis” form as per SOP “Outside Laboratory Testing” with relevant necessary information. | |
| 5.1.12 | If tests to be carried out as per IHS, copy of the protocol to be enclosed or scan copy to be mailed. | |
| 5.1.13 | Analyst should fill in the necessary details on the Analytical work report according to ‘Finished Product Inward Register’ and ‘Semi Finished Product Inward Register’ and start the analysis as per standard testing procedure and specification. | |
| 5.1.14 | Ensure that all the instruments are calibrated before use. | |
| 5.1.15 | Analyst should refer to the SOP of instrument before operation and update the instrument operation logs immediately after use. | |
| 5.1.16 | After the analysis, analyst should hand over the Analytical Work Report to Supervisor/Reviewer for data checking. | |
| 5.1.17 | If Supervisor/Reviewer observed any discrepancy with analysis or analytical data, he / she should consult to Head of the Department for investigation. |
| 5.1.18 | If all the relevant data on Analytical work report complies as per Pharmacopoeia or IHS requirement or both, Supervisor/Analyst should prepare “Certificate Of Analysis” as per SOP “Preparation of Certificate Of Analysis”. | |
| 5.1.19 | Quality Control Head shall verify and approve the COA and release the Finished Product or Semi Finished Product (if required). | |
| 5.1.20 | After approval of COA, Supervisor/QC Head shall intimate Quality Assurance Department and hand over the complete report with COA to Quality Assurance Department. | |
| 5.1.21 | Leftover samples should be destroyed as per SOP “Destruction of Laboratory Waste”.
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| 5.1.22 | During analysis if analyst observes the results out of specification or out of limits, he / she should report to the Supervisor or Head of the Department. | |
| 5.1.23 | Supervisor shall initiate investigation as per SOP “Out of Specification” by filling OOS form. | |
| 5.1.24 | After completion of investigation, categorise the observation as analyst error, reagent error, instrument error or material defect. | |
| 5.1.25 | Based on detailed investigation and type of error decision shall be taken for release or rejection of the product. | |
| 5.1.26 | For non conformance of product refer SOP “Control of non-conforming products”. | |
| 5.1.27 | Update the Finished Product Inward Register or Semi Finished Product Inward Register after release. |
- Definitions / Abbreviations:
- Definitions :
- Finished Product: A finished dosage form, for example a tablet, capsule or solution that contains an active pharmaceutical ingredient, generally but not necessarily, in association with inactive ingredients in a final marketed pack.
- Bulk or Semi-Finished Product: Any products that are obtained during the manufacturing process and that with further processing can become finished products.
- Abbreviations :
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| QC | Quality Control |
| QA | Quality Assurance |
| COA | Certificate Of Analysis |
| IHS | In-house Specification |
| OOS | Out Of Specification |
| i.e. | That is |
| A. R. No. | Analytical Reference Number |
| No. | Number |
*Note – Ready to use SOP available in “DOWNLOAD” Section.