SOP Title: Analysis of Samples at Outside Testing Laboratory
- Objective:
To lay down the procedure for Approval of Outside Testing Laboratory and Analysis of Samples at Outside Testing Laboratory
- Scope:
This procedure is applicable for Outside Testing Laboratory for Identification, Selection, Qualification and Approval in the Quality Control Department.
- Responsibility:
- Quality Control Department: To prepare and review the SOP. To follow the procedures for Approval of Outside Testing Laboratory as per this SOP.
- Quality Assurance Department: To review and approve the SOP and Annexure.
- Accountability:
Head Quality Control Department, Head Quality Assurance Department
- Procedure:
| 5.1 | Initial selection: | |
| 5.1.1 | Quality Control Manager and Quality Assurance Manager shall initialize selection process of the Outside Testing Laboratories as per organisation requirement. | |
| 5.2 | Evaluate the Outside Testing Laboratory for following aspects: | |
| 5.2.1 | Whether their Laboratory compliance as per GMP requirement. | |
| 5.2.2 | Whether they have experience with method development and/or method validation according to cGMP requirements. | |
| 5.2.3 | Whether they have experience of QC activities and approval of QC results according to GMP | |
| 5.2.4 | 1. Whether they have sophisticated equipment’s for analytical support. | |
| 5.2.5 | 2. Whether they have technical knowledge and expertise. | |
| 5.2.6 | Whether they have Quality Risk Assessment system. | |
| 5.2.7 | 3. On the basis of evaluation study Outside Testing Laboratory to be selected. | |
| 5.2.8 | Following questionnaires /check list are to be sent to Outside Testing Laboratory and requested them to send their valuable feedback for the following topics: | |
| 5.2.9 | 1) Laboratory Management structure and Organogram.
2) List of analysts and areas of expertise in Quality Control section. 3) Laboratory Quality System – ISO 9001, ICH, GMP, GLP, GCP Copies of Certificates –yes/no. 4) List of Analytical Instruments and Use of Software like LIMS, Chromatography data systems and /or other automated systems – yes/no. 5) Computer System Validation, compliance of software, change control and deviation SOP’s related to software- yes/no. 6) Laboratory notebooks, analytical test records- yes/no. 7) Raw data handling system –facility is available – yes/no. 8) Analysts Training are conducting at regular intervals- yes/no. 9) Document control & Document retention / archiving policy facility is available? 10) Retain sample control facility is available? |
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| 5.2.10 | On receipt of relevant information’s as per given format and verified all information and all issues are resolved before conducting Audit. | |
| 5.2.11 | A qualified Quality Auditor, from Quality Assurance and Quality Control Expert would accompany the audit team. | |
| 5.2.12 | The checklist that was completed during the initial laboratory evaluation should also be verified during the Audit. | |
| 5.2.13 | The Auditors should focus on the effectiveness of the Laboratory Controls for the following procedures. | |
| 5.2.14 | 1) Analytical Method Development and Validation if applicable.
2) Analytical Method Transfer and Validation. 3) Verification of the accuracy of the analytical test results 4) Traceability of all instruments, procedures, reference standards, reagents and personnel involved in generating the test results. 5) Periodic qualification, calibration, monitoring and verification of equipment and instruments. 6) Quality System Procedures and Practices should be assessed for: a) Personnel qualification and training b) Document control c) Laboratory deviation investigations d) Out of Specification (OOS) investigation. e) Complaints handling. |
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| 5.2.15 | Based on the Audit report, Outside Testing Laboratories shall be shortlisted. | |
| 5.2.16 | Those laboratories which complies with the Internal Quality Assessment Audit shall be selected and Agreement shall be done with these laboratories. |
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| 5.2.17 | Update the list of approved laboratories as per Annexure. | |
| 5.3 | Periodic Evaluation: | |
| 5.3.1 | On annual basis, the outside testing lab performance should be assessed for following data. | |
| 5.3.2 | 1) All results are received under agreed timelines.
2) Customer complaints regarding analytical results. 3) Response time for complaints and queries. |
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| 5.4 | Performance: | |
| 5.4.1 | a) If fully satisfied with laboratory performance –rated as satisfactory.
b) If performance is not satisfactory, additional time should be given for improvement. c) If the laboratory shows a low performance for more than one year, the approval should be reconsidered. |
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| 5.5 | Analysis of Samples at Outside Testing Laboratory | |
| 5.5.1 | Tests which cannot be performed in QC shall be get tested from approved outside contract testing laboratories. | |
| 5.5.2 | Prior approval shall be taken from Quality Control head before sending samples for outside testing. | |
| 5.5.3 | Sample shall be sent to contract testing laboratory as per test request form. | |
| 5.5.4 | On receipt of results from contract laboratory, the test result shall be checked by Quality person for accuracy, Data integrity and supporting documents. | |
| 5.5.5 | Samples can be sent to outside contract testing laboratories if any In-house instrument goes under breakdown. | |
| 5.5.6 | Quantity of sample shall be send to contract laboratories as per mentioned in the specification or specific requirement given by contract laboratory. | |
| 5.5.7 | If there is no discrepancy found in testing reports and supporting data, the results shall be reported in AWR. Testing reports & supporting data shall be attached with AWR. The contract laboratories bill can be approved and send to account department for further processing. | |
- Definitions / Abbreviations:
- Definitions:
- Abbreviations:
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| QC | Quality Control |
| QA | Quality Assurance |
| GMP | Good Manufacturing Practice |
| cGMP | Current Good Manufacturing Practice |
| LIMS | Laboratory Information Management System |
| ICH | International Conference on Harmonisation |
| ISO | International Organisation for standardisation |
| GCP | Good Clinical Practice |
| GLP | Good Laboratory Practice |
*Note – Ready to use SOP available in “DOWNLOAD” Section.