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Standard Operating Procedure (SOP) and Protocol for Microbiologist Qualification (validation) to establish and assure that Microbiologist is capable of performing Microbiological testing in Microbiology Department.

Microbiologist Qualification

1.0   PURPOSE :

• • The purpose of this Standard Operating Procedure (SOP) is to lay down the Procedure for Microbiologist Qualification (validation) to establish and assure that Microbiologist is capable of performing Microbiological testing in Microbiology Department.

2.0   SCOPE :

• • This SOP is applicable for Analyst/Reviewer Qualification (validation) of newly joined microbiologists for routine analysis and re-qualification of existing microbiologists in the Microbiology Department.

 3.0   RESPONSIBILITY – MICROBIOLOGIST QUALIFICATION :

• • The technical staff of QC -Microbiology shall be responsible :

• • To perform qualification activities as per this SOP.

• • Section Head -Microbiology shall be responsible:

• • Impart the training of this SOP prior to qualification.

• • Ensure the Procedure for Analyst/Reviewer Qualification as per this SOP.

• • Review & evaluation of Analyst and Reviewer Qualification Data.

• • Demonstrate the activity as and when required.

• • Maintain the list of qualified microbiologist& reviewers.

• • Head Quality Control (QC) shall be responsible:

• • To certify the microbiologist.

• • To ensure the adherence to this SOP.

• • Head Quality Assurance (QA) /Designee shall be responsible :

• • To ensure the implementation and compliance of SOP.

4.0   PROCEDURE – MICROBIOLOGIST QUALIFICATION :

• • General Instructions – Microbiologist Qualification:

• • • After completion of induction training (New Joinee in Microbiology department), he/she shall undergo GMP/GLP and relevant SOPs training (which is relevant to his/her job function) as per the current version of SOP- Training Management.

• • • A newly joined Microbiologist shall be trained for his/her job assigned by Executive/Section Head of Microbiology department.

• • Methodology- Microbiologist Qualification:

• • • Initially for a new Microbiologist, after completion of the training, H.O.D. -Microbiology/Designee shall identify the Microbiologist and activity in which his/her qualification is required.

• • • Section Head/ Head QC shall allot sample with codification to Microbiologist on the same day of Analysis.

• • • Microbiologist qualification of new entrant shall be based on the individual job responsibility of microbiologists with the respective work profile.

• • • Section head or designee shall assign the job responsibilities of the new entrants.

• • Microbiologist with previous experience (Microbiologist Qualification)

• • • After completion of job specific training, need for qualification of Microbiologist with previous experience shall be evaluated by section in-charges.

• • • This evaluation shall be based on personnel interaction with the Microbiologist, his expertise and assigned job responsibility.

• • • In either case, whether the Microbiologist is required to be qualified or not, Executive/Section in charge-QC shall endorse his opinion in writing.

• • Trainee Microbiologist Qualification (No previous analytical experience)

    • Trainee Microbiologist shall be trained for general procedures required in microbiological testing, viz., operation of equipment & instruments related to microbiology section, general preparatory work, sterilization processes, record maintenance, media preparation, culture maintenance, environment monitoring etc., under supervision of a qualified Microbiologist.

• • • After completion of training on general procedures microbiologist shall be trained on specialized testing. This shall be done for minimum of 15 days.

• • • During this period he/she can assist qualified microbiologist in preparatory work.

• • • Once the Microbiologist is trained he/she shall be qualified for carrying out these tests.

• • • Executive/Section in charge QC shall evaluate the Microbiologist for recommendation for Qualification.

• • Microbiologist shall be formally qualified for carrying out, one or more of the following tests;

• • Oral Dosage Forms

• • Gram Staining;

• • Total Aerobic Viable count;

• • Test for specified microorganism (Pathogens Identification).

• • Sterile Dosage Forms

• • Gram Staining

• • Total Aerobic Viable count;

• • Test for specified microorganism (Pathogens Identification);

• • Test for Sterility;

• • Bacterial Endotoxin Test

• • The Microbiologist shall be qualified (wherever applicable) for the following tests:

• • Microbial limit test of raw material and finished product.

• • Sterility testing (Open system and close system).

• • Bacterial Endotoxin test (Gel clot testing and KTA testing).

• • LBPC Testing.

• • The analysis shall be carried out in triplicate (01 samples in 03 sets) and results shall be reported in the respective analytical test data sheets of a particular test.

• • The new Microbiologist to be qualified shall perform parallel testing along with previously qualified Microbiologists in the case of MLT and LBPC testing.

• • The results shall be recorded in respective formats or printout of results shall be attached with qualification data.

• • Previously approved samples results shall be considered to check the result variation in the case of BET.

Related: Checklist for Microbiology Data Review

• • For sterility qualification results obtained from the trainee Microbiologist shall be accordingly as per prepared samples i.e growth shall be observed in spiked samples while other samples shall show No growth.

• • Results shall be recorded in respective formats or printout of results shall be attached with qualification data.

• • Qualification criteria of microbiologists shall be considered according to Annexure No. 1- “Specification for Qualification”.

• • If the results are found out of acceptance criteria, the immediate supervisor shall conduct the investigation for the cause and if it is due to an analytical error,

• • Then the Microbiologist shall be retrained for respective SOPs/Procedure and shall be prequalified.

• • The above activity shall be performed one time, if Microbiologist is not qualified in the second attempt, Head QC / QA shall decide for further action.

• • Microbiologist Qualification For Sterility Testing :

• • New Microbiologist will be qualified against the prepared sample by the section head for Sterility testing by the membrane filtration method.

• • These prepared samples (3 sets of 20 vials each) will be analyzed by the new microbiologist and the methodology and result will be reviewed to qualify the new microbiologist.

• • The above-prepared sample’s identity is kept highly confidential and should not be disclosed by Section head to Microbiologist.

• • Out of these 03 sets of prepared samples, first set of the sample (20 vials) may be prepared by filling 20 vials with 10 ml WFI and then autoclaving them invalidated gravity cycle,

• • The second set of samples may be prepared by contaminating 1 or 2 vials among the 20 autoclaved WFI vials with 0.1 ml of 10-100 cells of any of the available cultures.

• • The third set of samples is either similar to the first set or second set or some other samples sequence may be prepared as decided by section Head.

• • Spiking of samples shall be carried out in MLT area laminar airflow while sterility analysis shall be carried out in sterility area laminar airflow.

• • After analysis sterility area shall undergo a fogging process and thoroughly cleaned with a disinfectant in use to mitigate any risk of area contamination.

• • The actual identity and sequence of the above-prepared sample sets is to be entered by section head in the format no. 2 which is to be kept confidential by him till the completion of the test.

• • New Microbiologist shall analyze the samples as per the current version of Sterility SOP and Test results shall be filled in the current version of format “Sterility Test Report” by individual and shall be attached with Microbiologist qualification report of the individual.

• • The results should comply as per the specification mentioned in Annexure No. 1 “Specification for Qualification”(wherever applicable).

• • The summary of the results of tests shall be recorded and evaluated in the format no 6 “Evaluation data sheet for microbiologist qualification”

• • Microbiologist Qualification For MLT Testing :

• • For Microbiologist qualification in MLT testing the 3 sets of previously pre-approved sample is given to the microbiologist by giving them coding as mentioned above.

• • The actual identity of the sample should be kept confidential by the section head.

• • The Microbiologist shall analyze the samples as per the current version of the SOP Microbial Limit Test and record the results in the Microbial limit test report format of respective SOP.

• • The results should comply as per the specification mentioned in Annexure No.1 “Specification for Qualification”.

• • Similarly, one sample (same product and same batch no.) shall be given to previously qualified Microbiologist to carry out the comparative analysis.

• • New Microbiologist, as well as Qualified Microbiologist, shall analyze the samples as per the current version of Microbial Limit Test SOP and test results shall be filled in the current version of the format “Microbial Limit Test Report” by individual and shall be attached with Microbiologist qualification report of the individual(wherever applicable).

• • The summary of the results of the respective tests shall be recorded and evaluated in the Analytical test data sheet for microbiologist qualification format no. 1 “Comparative evaluation data sheet for microbiologist qualification (For MLT and LBPC test)”.

• • Microbiologist Qualification For BET Testing :

• • For Microbiologist qualification in BET testing the 3 sets of previously pre-approved sample is given to the microbiologist by giving them coding.

• • The actual identity of the sample should be kept confidential by the section head.

• • The Microbiologist shall analyze the samples as per the current version of the SOP – Bacterial Endotoxin Test (BET) and record the results in the format “Analytical test data sheet for Bacterial Endotoxin test” provided in the respective SOP

• • If BET is performed by KTA (Kinetic Turbiditic Assay) method electronically generated report obtained from Instrument shall be attached with other qualification data.

• • The result should comply as per the specification mentioned in Annexure No. 1 “Specification for Qualification”(wherever applicable).

• • The summary of the results of the respective tests shall be recorded and evaluated in the Analytical test data sheet for microbiologist qualification format no. 6 “Evaluation data sheet for microbiologist qualification(For Sterility and BET test)”

• • Microbiologist Qualification For LBPC Testing :

• • For Microbiologist qualification in LBPC testing, the 3 sets of the previously pre-approved samples are given to the microbiologist by giving them coding.

• • The Microbiologist shall analyze the samples as per the SOP –“Procedure for Cleaning, Operation and Calibration of Liquid Particle Counter” & Record the activity.

• • The result should comply as per the specification mentioned in Annexure No. 1 “Specification for Qualification” (wherever applicable).

• • Similarly, one sample (same product and same batch no.) shall be given to previously qualified Microbiologist to carry out the comparative analysis.

• • Electronically generated reports obtained from Instrument shall be attached to an individual’s qualification document.

• • The summary of the results of the respective tests shall be recorded in a format no. 6 “Evaluation data sheet for microbiologist qualification (for MLT and LBPC test)”.

• • After reviewing the microbiologist report, section in-charge shall handover the report to QC Head for final approval where the QC Head shall approve the Microbiologist qualification certificate as per Format No.4.

• • After the approval of the Microbiologist qualification certificate, Microbiologist can perform the testing in the respective section allotted to him/her by the QC Head.

• • Microbiologist – Reviewer Qualification:

• • Section Head / GLP section shall prepare the dummy templates for reviewer qualification containing several identified errors.

• • The Reviewer shall qualify by reviewing a dummy template containing errors.

• • The reviewer needs to identify the errors in the template provided to evaluate their reviewing capabilities.

• • The outcome of the reviewer’s findings shall verify against the known errors listed in a separate answer sheet.

• • The evaluation of the reviewer qualification done in Format No. 7 “Reviewer Qualification Data Sheet” (But not limited to) by the training coordinator/Section Head and shall handover the data to QC Head for final approval where the QC Head shall approve the reviewer qualification certificate as per Format No. 8.

• • Re-qualification Criteria of Microbiologist:

• • The Microbiologist needs to be re-qualified in the following situations :

• • If there is a more then 3 months gap in performing the particular testing.

• • The occurrence of 3 OOS (Microbiology) due to analyst error in a month.

• • If there are 5 lab incidents related to the analytical errors made by the analyst in a month.

• • If Qualification data lost (By following Appropriate QMS Tool i.e. Incident).

5.0   ABBREVIATIONS AND DEFINITIONS – MICROBIOLOGIST QUALIFICATION

• • MLT: Microbial Limit Test

• • BET: Bacterial Endotoxin Test

• • TAMC: Total Aerobic Microbial Count

• • TYMC: Total Yeast and Mould Count

• • Cfu: Colony-forming Unit

• • CSE: Control Standard Endotoxin

• • LAL: Limulus Amebocyte Lysate

• • Ml: Milliliter

• • LBPC: Liquid Borne Particle Count

• • GMP: Good Manufacturing Practices

• • GLP: Good Laboratory Practices

• • OOS: Out Of Specification

• • KTA: Kinetic Turbidity Assay

5.0   ATTACHMENTS :

Annexure 1:  Specification for Qualification

Test	Trained Analyst	Trainee	Passing Criteria
Microbial limit test	In single	Test three Replicates	TAMC:  ± Two Fold Results value obtained from Trained analyst. TYMC: ± Two Fold Results value obtained from Trained analyst. Pathogen: As per Specification (For TAMC and TYMC test, results shall not exceed the maximum limit of the products and results shall lie within acceptance criteria specified for various products.)
Sterility Test	N.A	Test three Replicates	As per Prepared sample expected results
Bacterial Endotoxin Test	N.A.	Test three Replicates	Results shall match with previous results of approved samples.
LBPC	In single	Test three Replicates	The variation in the results should be in the range of ± Two Fold of results obtained from trained analysts. (Samples results shall not exceed the maximum limit of the products and results shall lie within acceptance criteria specified for various products.)

Format 1: List of Allotted Sample for Analyst Qualification

Sr. No.	Analyst Name	Product	Batch No.	Date of analysis	Code Assigned	Type of test	Result	Approved analyst Name

 

Type of test	Result	Expected Result	Allotted by	Done  by	Checked by	Remarks

 

Format 2: Actual Identity of Allotted Sample for Analyst Qualification

Sr. No.	Date	Analyst Name	Product	Batch No.	Code Assigned	Allotted by

Format 3: List of Qualified Analyst/Reviewer

Sr. No.	Name	Category   (Analyst/ Reviewer)	Qualified On	Verified By	Remarks

Format 4: Certification of Qualified Microbiologist

MICROBIOLOGIST QUALIFICATION CERTIFICATE Qualification completed on :_____________       Test :______________                         This is to certify that Mr./Ms._ _ _ _ __ _ _ _ _ _ _ _ _ _ _ _ Employee Code :_ __ _ _ _ _  performed above test satisfactory as per the laid down procedure. The acceptance criteria found complying as per the SOP. The microbiologist shall be subjected to consideration for doing routine analysis. Approved By (Sign / Date) ______________________ (Quality Control Head)

Format 5: Comparative Evaluation data Sheet for Microbiologist Qualification (For MLT/LBPC Test)

Name of Analyst			Name of approved Analyst
Sample			Name of Sample
Test			Test
Sample gave on			Sample gave on
Date of Analysis			Date of Analysis
Details of the instrument used in the analysis	Instrument	(I.D)	Details of the instrument used in the analysis	Instrument	(I.D)

Format 6:  Evaluation of datasheet for Microbiologist Qualification (For Sterility/BET Test)

Name of Analyst
Name of Sample
Test  performed
Sample given on
Date of Analysis
Date of Report
Method used		Sterility: Open system/Close system	BET: KTA/Gel Clot
Details of the instrument used in the analysis	Instrument	(I.D)

 

Sample	Code No.	Results	Expected/Approved Results	Status
1.
Analyzed By: Date:			Checked by: Date :

Format 7:  Reviewer Qualification Data Sheet

Template Issued By/Date :

Topic: Review of dummy template Product/Material name :

Errors identified by Reviewer :

Errors not identified by Reviewer :

Total no. of errors in the template :

No. of additional errors identified by the reviewer:

% Evaluation : (Evaluation Criteria : Not Less than 80%):  (Calculate against previously identified errors) (Additional Errors identified by the reviewer, incorporeal in dummy template for future evaluation)

Evaluation : The trainee has ______________ (understood/not understood) this phase of the training and _____________(Qualifies/does not qualify) for reviewing the microbiology analytical raw data sheets/electronically generated Reports.