Microbiologist Qualification SOP (Example Template)

In short: This is an illustrative SOP showing how a QC microbiology laboratory can train a new microbiologist, test competence with coded samples and authorise the person for specific tests (MLT, sterility, BET, LBPC). Numerical criteria below are example in-house criteria; adapt them under your own quality system and the approved test methods.

1. Objective

To describe how a microbiologist is qualified, so that the laboratory has documented evidence that the person can perform the assigned microbiological tests correctly before doing routine work.

2. Scope

This example SOP applies to newly joined microbiologists (analyst and reviewer roles) and to requalification of existing microbiologists in the QC Microbiology department. It sits beside, and does not replace, method validation, growth-promotion checks and the site training procedure (Training of employees). The same approach for chemistry analysts is in QC analyst qualification SOP.

3. Why this is needed (regulatory basis)

• EU GMP, Part I, Chapter 2 (Personnel), revision of 16 August 2013: training must suit the duties assigned (2.10, 2.11); continuing training is required and its practical effectiveness should be periodically assessed; training programmes are approved by the head of Production or Quality Control; training records are kept (2.11). People working where contamination is a hazard need specific training (2.12).
• WHO good practices for pharmaceutical microbiology laboratories (WHO TRS 961, Annex 2, 2011), section 1: microbiological testing is performed and supervised by an experienced person qualified in microbiology; staff need basic microbiology training and practical experience before working on the scope of testing (1.1); records of qualifications, training and experience are kept (1.2); personnel may test samples only when recognised as competent or under adequate supervision, competence is monitored continuously with retraining where needed, and competence is verified before a method that is not in regular use is performed (1.4). The general WHO guideline for QC laboratories (TRS 1052, Annex 4, 2024) expects documented competence requirements and a training policy, but states in paragraph 1.6 that it does not cover microbiology laboratories.
• US CGMP: 21 CFR 211.25(a) requires personnel to have education, training and experience suited to their functions, with continuing CGMP training.

None of these documents prescribes a specific qualification test, number of replicates or fold-difference limit. Those are decisions of the site and are shown below as examples.

4. Responsibilities

5. Procedure

5.1 General requirements

1. After induction, the new microbiologist completes GMP, GLP and job-relevant SOP training under the current training procedure.
2. The Section Head identifies the tests for which the person needs qualification, based on the job profile, and assigns responsibilities.
3. The Section Head or Head QC allots coded samples on the day of analysis. The identity and expected result of each sample are kept confidential until the evaluation is complete (record in Format 2).
4. Each test is performed in triplicate (one sample, three sets) and results are recorded on the normal test data sheet or attached as instrument printouts.
5. Results are compared with the acceptance criteria in Annexure 1.

Tests covered (where applicable): microbial limit test (MLT) of raw materials and finished products, sterility test (open and closed systems), bacterial endotoxin test (BET: gel clot and kinetic turbidimetric), and liquid-borne particle count (LBPC).

5.2 Sterility test qualification

1. The Section Head prepares three coded sets of 20 vials. Example design (example in-house criterion): set 1, 20 vials of water for injection autoclaved by a validated cycle; set 2, the same, with one or two vials deliberately contaminated with a small, known inoculum of an available culture; set 3 as set 1 or 2 or another sequence decided by the Section Head.
2. Spiking is done in the MLT area under laminar airflow, never in the sterility testing area.
3. The trainee tests the sets by the membrane filtration method as per the current sterility SOP, reporting on the sterility test report form.
4. Expected outcome: growth in spiked vials only; no growth in the others. Record the summary on Format 6.
5. After the exercise, the sterility area is fogged and cleaned with the disinfectant in use to remove any contamination risk from the deliberate spiking.

5.3 MLT qualification

1. Three sets of a pre-approved coded sample are given to the trainee, who tests them as per the current MLT SOP.
2. One sample of the same product and batch is tested in parallel by an already qualified microbiologist.
3. Compare the total aerobic microbial count (TAMC) and total yeast and mould count (TYMC) results, and check the specified-organism result against the product specification. Record on Format 5.

5.4 BET qualification

1. Three sets of pre-approved coded samples are tested as per the current BET SOP. For the kinetic turbidimetric method, attach the instrument-generated report.
2. Results are compared with the previously approved results for those samples. Record on Format 6.

5.5 LBPC qualification

1. Three sets of pre-approved coded samples are tested as per the SOP for cleaning, operation and calibration of the liquid particle counter.
2. A parallel sample is tested by a qualified microbiologist; attach the instrument reports. Record the summary on the evaluation sheet.

5.6 Approval

The Section Head reviews the report and passes it to Head QC, who approves the Microbiologist Qualification Certificate (Format 4). Only after approval may the microbiologist perform that test independently. The certificate should state the tests covered.

5.7 Reviewer qualification

1. The Section Head or GLP section prepares a dummy template (a completed data sheet or report) containing known, listed errors.
2. The reviewer examines it; the findings are checked against a separate answer sheet and recorded on Format 7.
3. Head QC approves the reviewer qualification certificate.

Example in-house criterion: the reviewer must find at least 80% of the known errors. Errors found in addition to the known ones are added to the template for future evaluations.

5.8 If the criteria are not met

The immediate supervisor investigates. If the cause is analyst error, the microbiologist is retrained on the relevant SOP and procedure and qualified again. Example in-house criterion: one repeat attempt is allowed; if the second attempt fails, Head QC and Head QA decide the next step.

5.9 Requalification

Example in-house criteria (set your own triggers in your approved procedure):

• more than 3 months without performing the particular test;
• three OOS results attributed to analyst error in one month;
• five laboratory incidents linked to the analyst’s errors in one month;
• loss of qualification data (handled through the quality system as an incident).

Method changes, new equipment or an investigation that finds a training gap are also sensible triggers.

6. Annexure 1: Example acceptance criteria

Example in-house criterion (not a pharmacopoeial requirement; justify with your own method validation data):

7. Formats

Each format should capture at least: name and employee code, test, sample and code, dates, instrument ID, result, expected result, who allotted, performed and checked, and remarks. Format 4 carries the qualification date, test, and approval signature and date of Head QC.

8. Records

Keep the training record, coded-sample record, raw data, instrument printouts, evaluation sheets and certificate under document control. Where these relate to a product batch, retain them for at least 1 year after the expiry date of the respective product batch (EU GMP Part I Chapter 4 §4.11, or 5 years after QP certification if longer; 21 CFR 211.180(a)), and longer if local law or the marketing authorisation requires. Keep personnel qualification records for the period set by the site procedure.

9. Abbreviations

BET: Bacterial Endotoxin Test; CSE: Control Standard Endotoxin; GLP: Good Laboratory Practice; GMP: Good Manufacturing Practice; KTA: Kinetic Turbidimetric Assay; LAL: Limulus Amebocyte Lysate; LBPC: Liquid-Borne Particle Count; MLT: Microbial Limit Test; OOS: Out of Specification; TAMC: Total Aerobic Microbial Count; TYMC: Total Yeast and Mould Count; CFU: Colony-forming unit.

Frequently asked questions

Is a fixed requalification interval required for microbiologists?

The guidance cited above asks for continuing training with periodic assessment of its effectiveness, continuous monitoring of competence, and re-verification of competence before a method not in regular use is performed (WHO TRS 961 Annex 2, 1.4). It does not set a fixed interval or a list of triggers. Define them in your approved procedure.

Why are samples coded and the identity kept confidential?

So that the result reflects the trainee’s technique and not knowledge of the expected answer. Keep the code key under control until the evaluation is complete.

Can a trainee work independently once the tests are done?

Not until the qualification is reviewed and approved by Head QC. Until then, work under supervision of a qualified microbiologist.

See also

• Good microbiological laboratory practice
• Checklist for microbiological analytical data and reports
• What is the sterility test?

References

• European Commission, EudraLex Volume 4, EU GMP Guidelines Part I, Chapter 2 “Personnel”, revision of 16 August 2013 (in operation 16 February 2014), §2.10–2.12: health.ec.europa.eu.
• European Commission, EudraLex Volume 4, Part I, Chapter 4 “Documentation”, Revision 1 (2011), §4.11: health.ec.europa.eu.
• WHO, Technical Report Series No. 961, 2011, Annex 2: WHO good practices for pharmaceutical microbiology laboratories, section 1 (Personnel): who.int.
• WHO, Technical Report Series No. 1052, 2024, Annex 4: WHO good practices for pharmaceutical quality control laboratories, paragraph 1.6 (scope): who.int.
• United States, 21 CFR 211.25(a) and 211.180(a), current eCFR: ecfr.gov.