SOP Title: Allotment of Job Responsibilities in Quality Control Department
- Objective:
To lay down the procedure for Allotment of Job Responsibilities in Quality Control Department.
- Scope:
This procedure is applicable for Allotment of Job Responsibilities of Analyst, Executive, Supervisor, and Manager in Quality Control Department.
- Responsibility:
- Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Allotment of Job Responsibilities 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:
| Sr. No. | Procedure | |
| 5.1 | General Responsibilities:- All Quality Control Staff | |
| 5.1.1 | Keep Laboratory neat and clean. | |
| 5.1.2 | Careful usage of organisation resources without any wastage. | |
| 5.1.3 | To identify hazards and safety issues in Laboratory and inform Head of the Department. | |
| 5.1.4 | Keep good and healthy working culture in the Laboratory. | |
| 5.1.5 | Keep all the documents/materials at respective places after use. | |
| 5.1.6 | Switch off lights and instruments whenever not required. | |
| 5.1.7 | Minimise wastage of papers. | |
| 5.1.8 | Maintain Good Laboratory Practices in Laboratory. | |
| 5.1.9 | Always think about environment hazards before generating waste. | |
| 5.1.10 | Do not perform any job without proper training. | |
| 5.1.11 | Read the Instrument/Equipment SOP’s and Standard Testing Procedures carefully before starting the analysis. | |
| 5.2 | Responsibilities of Quality Control Head/ Quality Control Manager: | |
| 5.2.1 | Quality Control Head/ Manager is responsible for the overall monitoring of the Department. | |
| 5.2.2 | Maintaining Good Laboratory Practices. | |
| 5.2.3 | Taking care of trouble shooting during day to day analysis. | |
| 5.2.4 | Maintaining good rapport with all other Departments and outside parties. | |
| 5.2.5 | Keeping control on new product analysis and development. | |
| 5.2.6 | Discussion of quality problem, if any with higher managements. | |
| 5.2.7 | Evaluation of stability data. | |
| 5.2.8 | Monitoring and evaluation of validation samples and data. | |
| 5.2.9 | Preparation and updating of SOP’s as per requirement and current guidelines. | |
| 5.2.10 | Investigation of OOS/Incidents/Deviations. | |
| 5.2.11 | Conducting trainings to quality control staff. | |
| 5.2.12 | Impact evaluation of OOS/Incidents/Deviations. | |
| 5.2.13 | Ensuring readiness for non-regulatory, regulatory and internal audits all the time. | |
| 5.2.14 | Release and Approval of Raw Material/Packing Material/Finished Product/In process Sample reports and COA on time. | |
| 5.2.15 | Impact evaluation of change control. | |
| 5.2.16 | To identify new manpower requirement. | |
| 5.2.17 | To identify new Instrument/Equipment requirement. | |
| 5.2.18 | To ensure safety of Quality Control staff in the Department. | |
| 5.2.19 | To monitor and evaluate performance of Quality Control staff. | |
| 5.2.20 | Any other responsibility assigned by the management as situation demand. | |
| 5.2.21 | To maintain training records up to date. | |
| 5.3 | Responsibilities of Supervisor/Group Leader/Executive/Assistant Manager: | |
| 5.3.1 | Maintaining Good Laboratory Practices. | |
| 5.3.2 | Taking care of trouble shooting during day to day analysis. | |
| 5.3.3 | Discussion of quality problem, if any with higher managements. | |
| 5.3.4 | Evaluation of stability data. | |
| 5.3.5 | Monitoring and evaluation of validation samples and data. | |
| 5.3.6 | Preparation and updating of SOP’s as per requirement and current guidelines. | |
| 5.3.7 | Review of analytical reports of Raw Material/Packing Material/ In process Sample / Finished Product and Microbiology reports. | |
| 5.3.8 | Review of Instrument/Equipment usage log books. | |
| 5.3.9 | Daily work planning to the analysts. | |
| 5.3.10 | Review of new documents like Standard Testing Procedures, Specifications, Protocols etc. | |
| 5.3.11 | Checking of all GMP records in the Laboratory. | |
| 5.3.12 | Initiation of change control. | |
| 5.3.13 | Monitoring safety in Quality Control Department. | |
| 5.3.14 | Checking calibration reports and preventive maintenance records. | |
| 5.3.15 | Conducting trainings to Quality Control staff. | |
| 5.3.16 | To verify training records of Quality Control staff. | |
| 5.3.17 | To maintain training records up to date. | |
| 5.3.18 | Updation of sample inward records for Raw Material/Packing Material/Finished Product/In process Sample/Stability samples. | |
| 5.3.19 | Preparation and monitoring of Calibration/AMC schedule in Laboratory. | |
| 5.3.20 | Investigation of OOS/Incidents/Deviations. | |
| 5.3.21 | Maintaining all time readiness for non-regulatory, regulatory and internal audits. | |
| 5.3.22 | To ensure safety of Quality Control staff in the Department. | |
| 5.3.23 | Any other responsibility assigned by the management as situation demand. | |
| 5.3.24 | To ensure proper storage and handling of Chemicals/Media/Solvents/ Poisonous chemicals/Reference standards/Working standards as per SOP. | |
| 5.4 | Responsibilities of Analyst/Officer/Microbiologist: | |
| 5.4.1 | To follow Good Laboratory Practices. | |
| 5.4.2 | Sampling and analysis of Raw Materials/Packing Materials and maintaining records. | |
| 5.4.3 | Analysis of In process Samples/Finished Products and maintaining records. | |
| 5.4.4 | Preparation of Control Samples of Raw and Packing Materials. | |
| 5.4.5 | Stability Study Analysis as per plan. | |
| 5.4.6 | Sampling and analysis of water and water validation as per plan. | |
| 5.4.7 | Maintaining records of Instrument/Equipment usage log. | |
| 5.4.8 | Discussing any quality problems with Quality Control Head/Manager. | |
| 5.4.9 | Cleaning, maintenance and calibration of laboratory Instruments/Equipments as per schedule. | |
| 5.4.10 | Preparation of Reagents/Indicators/Volumetric Solutions and maintaining records. | |
| 5.4.11 | Procurement, Storage and Handling of Media/Chemicals/Solvents for analysis and maintaining stock and consumption records. | |
| 5.4.12 | To follow safety precautions during work. | |
| 5.4.13 | To maintain training records up to date. | |
| 5.4.14 | To maintain online documentation. | |
| 5.4.15 | All time readiness for non-regulatory, regulatory and internal audits. | |
| 5.4.16 | To complete analysis and reporting within stipulated time period. | |
| 5.4.17 | To file OOS/Deviation/Incident. | |
| 5.4.18 | To follow and work as per standard operating procedure. | |
| 5.4.19 | Daily reporting to quality control head/supervisor. | |
| 5.4.20 | Careful usage of organisation resources without any wastage. | |
| 5.4.21 | Any other responsibility assigned by the management as situation demand. | |
| 5.4.22 | Review of analytical reports. | |
| 5.4.23 | Execute daily work planning as per Standard Testing Procedure, Specification, Pharmacopoeia etc. | |
| 5.4.24 | Preparation of new documents like Standard Testing procedures, Specifications, Protocols etc. | |
| 5.4.25 | Preparation, handling and storage of Reference standards/Working standards as per SOP. | |
| 5.4.26 | Daily up keeping of laboratory. | |
| 5.4.27 | Environmental monitoring and maintaining records. | |
| 5.4.28 | Maintenance of cultures, preparation of subcultures, serial culture dilution, decontamination and maintaining records. | |
| 5.4.29 | Minimum inhibitory concentration, validation of disinfectants used and maintaining records. | |
| 5.4.30 | Growth promotion of media as per SOP and maintaining records. | |
| 5.4.31 | After allotment of Job Responsibilities, update ‘Employee Job Responsibilities’ as per Annexure | |
- Definitions / Abbreviations:
- Definitions:
- Abbreviations:
| Abbreviation | Expansion |
| OOS | Out Of Specification |
| AMC | Annual Maintenance Call |
| GMP | Good Manufacturing Practices |
| Etc. | Excetra |
*Note – Ready to use SOP available in “DOWNLOAD” Section.