SOP Title: Supervision of Work in Quality Control Department
- Objective:
To lay down the procedure for Supervision of Work in Quality Control Department.
- Scope:
This procedure is applicable for Supervision of Working System as per Good Laboratory Practices
in Quality Control Department.
- Responsibility:
- Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Supervision of Work 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 | General Check Points in Quality Control Department: | |
| 5.1.1 | General Laboratory cleanliness, maintenance, safety and Good Laboratory practice. | |
| 5.1.2 | Sampling procedure followed as per current SOP of Raw Materials and Packing materials. | |
| 5.1.3 | Analysis and reporting of Raw materials, Packing Materials, In process, Finished Products and Stability Samples. | |
| 5.1.4 | Calibration, Validation of instruments, equipments and its labelling. | |
| 5.1.5 | Reporting and recording of all the activities. | |
| 5.2 | Sampling Procedure and Status: | |
| 5.2.1 | Checks for the containers /bags/drums/boxes are sampled were properly cleaned and free from any physical deformity. | |
| 5.2.2 | Check the equipment used for sampling is same as specified in the current SOP for sampling. | |
| 5.2.3 | Check the containers /bags/drums/boxes sampled are identified and sampled as per defined sampling plan in current SOP of sampling. | |
| 5.3 | Labelling Procedure and Status: | |
| 5.3.1 | Check whether the containers /bags/drums/boxes are labeled as Under Quarantine are identified as Under Test (Yellow), Approved (Green), Rejected (Red). | |
| 5.3.2 | Check whether affixed sampled label for those containers, bags or drums, boxes from which sample is removed. | |
| 5.3.3 | Ensure that the approved sticker contains the details: Name, Quantity, Batch No., Potency/Assay, A.R. No., LOD, and Analysed by, date of approval, retest date and initial of approved competent technical person. | |
| 5.4 | Analysis Procedure and Supporting Data: | |
| 5.4.1 | Check the sample taken for analysis is entered in respective inward registers. | |
| 5.4.2 | Check the work sheets for the test performed are as specified in the official procedure or as per in-house specification. | |
| 5.4.3 | Ensure that the reagents/ solutions were available or not, for the test carried out and check date of preparation of solutions and standardization wherever applicable. | |
| 5.4.4 | Ensure that the equipment instrument used for analysis is calibrated and in working condition during testing. | |
| 5.4.5 | Check whether the reagents, solutions and chemicals used are prepared according to the standard procedure and discarded after expiry. | |
| 5.4.6 | Ensure that all reference samples are prepared from composite samples and are preserved under control temperature and humidity with proper record. | |
| 5.5 | Stability Studies: | |
| 5.5.1 | Check the scheduler of stability study meets the requirement as per standard operating procedure. | |
| 5.5.2 | Check whether the samples charged as per current SOP of stability studies. | |
| 5.5.3 | Check the format and data recorded during and after completion of the Stability testing. | |
| 5.6 | Calibration, Validation of Equipments / Instruments: | |
| 5.6.1 | Check whether all instruments/equipments are categorised with a calibration status label. | |
| 5.6.2 | Check the validation/calibration is conducted as per current Standard operating procedure. | |
| 5.6.3 | Check whether the facilities for conducting calibration and validation are certified and adequate. | |
| 5.6.4 | Check whether the records of calibration and validation are periodically maintained. | |
| 5.7 | Reporting and Records: | |
| 5.7.1 | Check whether the reports are generated for the sample tested documented online. | |
| 5.7.2 | Ensure that the report is complete in all respects and counter checked by the authorized person prior to release. | |
| 5.7.3 | Ensure that the equipment logs, and other related log books are updated on day to day basis. | |
| 5.8 | Laboratory Cleanliness, Maintenance and Safety: | |
| 5.8.1 | Check whether the laboratory is cleaned as per schedule. | |
| 5.8.2 | Check whether the floor, wall, lights and fans are cleaned and maintained properly. | |
| 5.8.3 | Check whether there is adequate fire extinguisher and proper ventilation and exit to ensure safety of personal working in laboratory. | |
| 5.9 | Microbiology/Microbiological Analysis: | |
| 5.9.1 | Check whether water analysis is carried out daily as per current SOP of water analysis. | |
| 5.9.2 | Check whether the reports are generated for the sample tested documented online. | |
| 5.9.3 | Check whether the fumigation is carried out and consumption of chemicals is recorded. | |
| 5.9.4 | Check whether environmental monitoring is carried out for department as per schedule and recorded. | |
| 5.9.5 | Check whether seasonal validation is carried out for all sampling points as per plan and reports are generated. | |
- Definitions / Abbreviations:
- Definitions :
- Abbreviations :
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| QC | Quality Control |
| QA | Quality Assurance |
| A. R. No. | Analytical Reference Number |
| LOD | Loss on drying |
| Qty | Quantity |
| No. | Number |
| Mfg. | Manufacturing |
*Note – Ready to use SOP available in “DOWNLOAD” Section.