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Standard Operating Procedure (SOP) & Guideline to define the role and responsibility of Quality Assurance in Laboratory (as Lab QA) in different activities.

Role & Responsibility of Quality Assurance in Laboratory (Lab QA)

1.0   PURPOSE:

• • The purpose of this SOP is to define the role and responsibility of Quality Assurance in the Laboratory (as Lab QA).

• • The approach of the Quality Assurance in Laboratory (as Lab QA) is to improve the level of compliance in quality control laboratory by reviewing analytical raw data (paper and electronic) and continuous system monitoring.

2.0   SCOPE:

• • This procedure is applicable to all the sections of quality control departments at the pharmaceutical drug manufacturing plant.

3.0   REFERENCES:

• • In House

• • SOP for Review of the Raw Data of Analysis

• • Procedure for Assigning of Job Responsibility

• • SOP for Audit trail review and privilege assigning policy.

4.0   RESPONSIBILITY – QUALITY ASSURANCE IN LABORATORY (LAB QA):

• • Lab QA shall be responsible to review the analytical raw data adequacy and accuracy as per (but not limited to) the checklists.

• • Quality Assurance Person (Lab QA) shall be responsible to provide the on-job training to the analysts as per requirements in Laboratory.

• • Lab QA shall be responsible to review the raw data and provide observations to the analysts if any discrepancy is observed during the review of data.

• • A quality Assurance Person (Lab QA) shall be responsible to ensure the adequacy of compliance for the observations in the Laboratory.

• • Analytical QA  shall be responsible to ensure handling of lab vents, incidents, deviations, OOS, OOC, and repeat analysis as per respective SOP.

• • Analytical QA shall be responsible to review electronic data and audit trail.

• • The Quality Assurance Person (Lab QA) shall be responsible to check the SOP and to ensure proper implementation of the system as per SOP in Laboratory.

5.0   ABBREVIATIONS:

• • COA: Certificate of Analysis

• • GMP: Good Manufacturing Practice

• • OOS: Out of specifications

• • OOC: Out of Calibration 

• • Lab: Laboratory

• • DEFINITION:

• • Analytical Raw Data: Data generated during sample analysis and record of original observations on which quality decisions are based is known as raw data. 

• • Example: Template, COA, chromatograms (electronic and hard copy), instrument ID, batch no. etc.

7.0   PROCEDURE – ROLE OF QUALITY ASSURANCE IN LABORATORY (LAB QA):

• • Quality Assurance Person (Lab QA) shall perform their task in the laboratory as mentioned below :

• • To review a minimum of 20% of the paper and electronic raw data & records generated in the QC laboratory as a secondary check by QA.

• • To issue, review, maintain, and archive GMP documents for QC lab.

• • Preparation of the schedule and conduct periodic quality control audits.

• • Ensuring each section of the quality control laboratory is covered in this periodic audit.

• • To review OOS, OOC, deviation, lab event, and non-conformities.

• • Ensure that the defined procedure is followed by QC to identify the root cause and establishment of corrective and preventive actions (Refer the SOP for CAPA).

• • To review the trend of following laboratory errors (but not limited to) and effective CAPA implementation to reduce analyst error

• • • Human-related error,

• • • System-related error,

• • • The instrument, and equipment malfunctioning

• • To monitor that QC is ensuring completion of analyst qualification activity prior to assign work to the analyst in the laboratory.

• • Intimate and update to QC head or designee pertaining to regulatory notification e.g. FAR, QP notification. (Refer the SOP for Field Alert Report – FAR)

• • Quality Assurance Person (Analytical QA) shall perform a periodic review of data integrity in Laboratory as per the defined process and checklist.

• • Ensure the life cycle management of laboratory instruments.

• • To perform periodic shop floor inspection of the lab to verify.

    • Cleaning of quality control laboratory

• • • Instrument usage logbook online entries, online documentation practices.

• • • Physical verification against documentation e.g.

• • • Column,

• • • Working standard vial,

• • • Benchtop solution,

• • • Chemical,

• • • Buffers,

• • • Volumetric reagents,

• • • Opening and expiry date of chemicals

• • • Calibration status of instruments & adherence to calibration master schedule.

• • • Balance leveling check.

• • • Temperature and humidity reports.

• • • Stability samples reconciliation

• • • Physical status of cupboards and drawers as well as for the correctness of the contents.

• • • Sample storage and analysis status. (Analysis pending, under analysis, and destroy samples).

• • • Practices against the standard operating procedure.

• • • Stability Study of Drug Product, Summary Report, Trend, etc.

• • After completion of the section head review, the section head/ analyst shall handover the analytical report (Laboratory Data) to the Quality Assurance reviewer (Lab QA) with all supporting data for review.

• • Head QC or designee and Lab QA shall assess the observations made by the reviewer on a quarterly basis and evaluate the repetitive type observation against analyst wise.

• • Head QC or designee and QA of QC shall review the data and evaluate the repetitive type observations against the analyst as per following but not limited to,

• • • Entries / Signature missing.

• • • Overwriting / Wrong entries.

• • • Wrong calculation/ Preparation /ATP not followed.

• • • Justification not written.

• • • Wrong material analyzed.

• • Head Lab QA or designee shall evaluate the repetitive type of failures for other analysts also.

• • Head Lab QA or designee shall interpret the conclusion of repetitive observations as identification of training needs / any change and/or clarity in the method of analysis etc. is possible to know based on which training / corrective and/or preventive action to be planned.

• • All Lab QA personnel shall undergo technical training by concern personnel from QA/ QC and from QC.

• • Annual training needs identification of Lab QA shall be done based on the Annual trend of review observation, Audit findings, etc.

• • The job responsibility of individual team members of the Lab QA shall be approved by the Quality Assurance head.

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