SOP : Responsibilities of Quality Control Dept.

SOP : Responsibilities of Quality Control Dept.

By PharmaState Academy
05/03/2019
Pharma Industry Guidelines, Quality Control, SOPs
3.98k
personnel qc sop, Quality Control, responsibilities of qc department, sop qc
0 Comments

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

For any feedback or suggestions write to us at info@pharmastate.com

Latest Blog