SOP for Analyst Qualification of Quality Control Analyst

            To provide detail procedure for Analyst qualification of Quality control analyst for the performance verification.    

            This SOP is applicable for qualification of Quality Control analyst working in QC laboratory at manufacturing facility of Pharmaceutical Industry .     

  • PROCEDURE:

All new joined analysts in the QC shall be qualified on the basis of accuracy, precision and GLP.

Head-QC shall decide nature of work and job responsibility of new recruit. Same shall be authorized by Head-QA.

Analyst shall be trained on all specific instruments, equipment, procedures, system and documentation as per requirement of the department.

Analysts shall be qualified for critical tests involving instruments eg. HPLC, GC, UV, IR, DISSOLUTION TESTER etc…

Existing experienced analysts shall be qualified every three years on critical tests & in case of change of job / instruments.

The Manager QC shall provide a coded sample (previously analyzed) to the analyst for analysis. Record of coding of samples shall be available with Manager QC (Refer Annexure – II)

The sample shall be coded as AQ-YY-001

Where “AQ” is Analyst Qualification

Third Character is “-” dash.

Fourth & Fifth characters “YY” is year

Sixth Character is “-” dash

Seventh character “001” is serial number

For example AQ-20-001

The identified sample shall be given to analyst along with details of procedure.

The analyst shall also be evaluated for compliance to GLP while working in QC

All the tests shall be performed in triplicate & % RSD shall be evaluated.

The test results shall meet the acceptance criteria as per the respective product specification.

The analyst shall follow the STP’s of the respective products and do all the documents as per current practices.

The raw data shall be finally reviewed by Head-QC and approved by Head- QA.

Analyst qualification card of each analyst shall be maintained by respective analyst or by department representative. (Refer Annexure – III).

In case analyst not meeting the acceptance criteria, the Manager QC shall look in to record and provide the on job training to the analyst. After the training, analyst shall be re-qualified as per procedure.

The analyst validation shall be performed for the critical tests defined in the table below.

  TestAcceptance Criteria
Assay (By HPLC/UV/ Potentiometry/Titrimetry)RSD shall NMT 2.0%
Related substances & Chromatographic PurityRSD NMT 5.0% for impurity more than 1.0% to 5.0% RSD NMT 10.0% for impurity more than 0.50% to 1.0% RSD NMT 15.0% for impurity Less than 0.50%
Residual SolventRSD NMT 15.0%
UVRSD NMT 15.0% for Abs value upto 0.50 RSD NMT 10.0% for Abs value more than 0.50 to 1.0 RSD NMT 5.0% for Abs value more than 1.0
Heavy metalsResults shall meet the product specification
FTIRIR should match the standard
Karl FisherRSD NMT 2.0% for moisture content more than 5.0% RSD NMT 5.0% for moisture content more than 3.0% to 5.0% RSD NMT 10.0% for moisture content more than 1.0% to 3.0% RSD NMT 15.0% for moisture content upto 1.0%
DissolutionResults shall meet the product specification

All analyst shall be issued with certificate based on their job responsibility followed with qualification after successful evaluation as per Annexure – VIII

Requalification:

            Every analyst shall be requalified periodically after every 3 years. Also if any OOS Investigation reveals the analyst error, concern analyst shall be retrained and requalified on that particular analytical technique.

  • TRAINING:

As per Employee Training Sop

  • DISTRIBUTION:

As per SOP of SOP

  • ANNEXURE:

Annexure I      : Analyst Qualification Record

Annexure II    : Identification for coded sample

Annexure III   : Analyst qualification card

Annexure IV   : Analyst Qualification Certificate

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