Sample Receiving, Storage and Allocating for Test in QC Laboratory
Abbreviations And Definitions
Procedure
1. Receive sample request form for raw materials & packaging materials from warehouse in QC laboratory.
2. Receive stability study, bulk/finished product samples of solid/sterile unit from QA in sample receiving room.
3. QA/QC sampler will inform the QC personnel to receive the sample. QC personnel will receive the sample along with respective document through sample receiving window from QA/QC sampler.
4. Check all the information of stability study, bulk/finished product of solid dosage and sterile dosage unit product sample like product name, batch number, batch size, mfg. date, exp. date, stability storage condition etc. are correctly written.
5. Check all the information written in Sampling plan & visual inspection sheet and the Sample label. Also check the tightness of sample polythene or sample container.
6. Ensure the sample quantity during receiving according to the sample quantity list or requirement.
7. After sampling or receiving of raw materials, packaging materials, bulk/finished product sample for solid dosage and sterile dosage unit, keep the individual samples in dedicated rack that has been labeled as “Finished Product Sample”, “Raw Material Sample”, “Packaging Material Sample”, and “Stability Sample” under lock & key of the sample storage room and under close supervision of QC Supervisor.
8. After receiving of product stability study sample for solid and sterile dosage unit, label all the samples and keep the individual samples in dedicated rack of dedicated stability chamber under close supervision of QC Supervisor. All these racks should contain proper labeling.
9. Keep all the Raw Material for solid dosage unit and Sterile Unit in to the defined desiccators immediately and close the cover of desiccators properly that no air can pass it.
10. The miscellaneous samples such validation samples, hold time samples etc. are received in Quality control lab through QA department along with approved protocol and test will be carried out as per protocol or approved method.
11. Supervisor/Asst. Manager/Sr. Asst. Manager/Deputy Manager, QC will distribute the respective test samples amongst the Analyst of QC for Testing as per the following things to be considered.
⇨ Training status of the Analyst on machines and respective method of analysis.
⇨ Check the Qualified Analyst list where all analysts are listed with test parameters after completion of analyst qualification.
⇨ Training on job relative SOP.
⇨ Experience of the Analyst.
⇨ Fatigues (workload) of the Analyst, previous history and any criticality on respective method.
⇨ Production demand/schedule meet up/urgency of releasing of the sample.
Allocate the analytical job to the analyst considering the above conditions and following the list of qualified analysts with parameters and instrument for which they are qualified.
12. Assign two or three persons if there are several lots/batches of same product/material if required. Distribute the test parameters among them for the total lots/batches in suitable manner. For example, assign HPLC assay and related substance tests to one person and assign rest of the chemical tests to another person.
13. Assign the critical jobs to the experienced analyst. Here critical means, relatively difficult HPLC/GC tests or chemical tests or new raw material, that is not familiar to the analysts.
14. Before the day of analysis or weekly basis which is applicable, Supervisor/ Asst. Manager/Sr. Asst. Manager/Deputy Manager, QC will allocate the Analyst job in computer excel sheet which is shared as read only file.
15. Analyst will open the excel sheet at the morning and see the sample which has been allocated for him.
16. Supervisor, QC will distribute the respective sample from sample storage room maintaining proper record in the work schedule and analyst will start the analysis according to approved standard test method.
17. Supervisor/ Asst. Manager/Sr. Asst. Manager/Deputy Manager, QC or his nominee will follow up schedule regular interval and take necessary guide during analysis if required.
18. If any work schedule needs to change, Asst. Manager/Sr. Asst. Manager/Deputy Manager, QC or his nominee can change the work schedule with mentioning the record in work schedule.
19. Update the schedule daily basis in excel and keep the status of assigned work.
20. Print and preserve the updated work schedule daily/weekly or monthly or when required for Finished Product / Raw Material / Packaging / Logistic team or as applicable.
21. Head of QC or his nominee will verify the work schedule as when required.
22. Job can be rotated based on work volume or priority of works within the all sections through the Head of QC.
23. List of analyst qualification will be updated when a new analyst will qualified.
24. Preserve the test samples in dedicated place after completion of analysis until all test has been completed and data reviewed, with a label of “Test ongoing samples”.
25. Dispose the samples after releasing the respective material. Update the relevant logbook for batch status and sample reconciliation.
26. For Sterile: No finished product samples for sterile unit will be kept as under test for more than 14 days for chemical test after receiving the samples.
For Solid: No finished product samples for solid dosage unit will be kept as under test for more than 30 days for chemical test after receiving the samples.
For Raw/Packaging: Release the raw /packaging materials within 30 days after receiving the Sample request form from warehouse.
For Stability study sample: Complete the chemical analysis of stability study sample.
References
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