1.Objective :

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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