To define the responsibilities of Quality Control Department.
2. Scope :
This procedure is applicable to all the personnel working in Quality Control Dept.
3. Responsibilities :
QC Analyst, QC in Charge, Lab Technicians, QC Reviewer, QC Section Head, QC Head, Quality Head
4. Procedure :
The quality unit(s) should be involved in all quality-related matters.
The quality unit(s) should review and approve all appropriate quality-related documents.
These responsibilities should be described in writing and should include but not necessarily be limited to:
- To maintain GLP (Good Laboratory Practices) in Quality Control Department.
- To prepare & follow the approved departmental SOPs.
- To prepare volumetric solution, reagents, buffer solution, indicator and maintain its record.
- To ensure proper cleanliness & housekeeping lab on daily basis.
- To make planner for the analysis of daily samples.
- To perform sampling, analysis and reporting of raw materials, packing materials, finished products, intermediates, in-process, stability sample and routine analysis.
- To destruct the left over quantity of samples after completion of analysis.
- To follow approved specifications and test procedure for analysis
- To perform AMT (Analytical Method Transfer), AMV (Analytical method Validation & verification)
- To perform standardization of volumetric solutions.
- To prepare the buffer solutions, reagents, volumetric solutions & discard them after its valid usage period.
- To prepare working standards, reference standards.
- To ensure availability of working standards & perform the qualification.
- To ensure availability of current specifications in the laboratory & all the obsolete versions shall be sent back to QA for retrieval.
- To perform analyst qualification.
- To register samples in system & feed the data in the system.
- Monthly report preparation.
- To provide on job training to the new joinees in QC & lab technicians.
- To record raw data and analytical results in analytical test data sheet.
- In case of any abnormalities or out of specification results observed, it shall be informed to the next level & follow the appropriate procedure for the logging & further investigation.
- To report lab incidents, out of specifications, out of trend, events &/or any deviations happened in lab.
- To ensure the calibration of the lab instruments to be performed before their due dates.
- To prepare master calibration planner & preventive maintenance planner, training schedule for the year.
- Preparation & review of Stability Study Protocols / reports, Hold Time study Protocols / Reports, Qualification Protocol / reports as per the defined procedure.
- To analyze stability, hold time study samples.
- To prepare stability summary report.
- To ensure the compliance of the lab observations.
- To review the analytical data, raw data & in case of any observations, ensure the adequacy.
- To ensure the data integrity.
- Establishing a system to release or reject raw materials, intermediates, packaging materials;
- To perform Audit Trail Review in the system
- Timely submission of analytical data to QA for the further release of batches
5. Abbreviations :
- QA : Quality Assurance
- QC : Quality Control
- GLP : Good Laboratory Practices
- AMT : Analytical Method Transfer
- AMV: Analytical Method Validation / Verification
- SOP : Standard Operating Procedure
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