OBJECTIVE:
The objective of this SOP is to define the mandatory requirements applying to the qualification for Microbiologist involved in various microbiological tests.
SCOPE:
This SOP is applicable for Microbiologist qualification, involved in microbiological analysis employed for testing of sterile and non-sterile drug substances and drug products or activities associated with the testing of sterile and non-sterile drug substances and drug products at {Company Name} {Location}.
RESPONSIBILITY:
- Microbiologist- to follow the procedure as per SOP.
- In charge-Microbiology/ Head-Quality Control: for review and approval of SOP.
- ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
PROCEDURE:
Principle:
Adequate education, training and qualification to perform specific job function is a GMP requirement. Accuracy of the test result depends upon qualified, properly trained and competent Microbiologist.
The Microbiologist qualification and their periodic assessment is important to evaluate the competency and analytical skill.
Qualification method:
The Microbiologist qualification schedule shall be prepared based on the tests performed in the Microbiology laboratory and the Job description of microbiologist.
Qualification activity should be performed under the supervision of trained and qualified senior Microbiologist.
Test related guidance documents and compendial methods shall be given to the microbiologist under qualification, to get basic understanding about the test.
Training on related SOPs shall be imparted and Dos and Don’ts and precautions to be taken during analysis shall be explained.
The required sample quantity shall be prepared or provided by the Laboratory trainer.
A practical demonstration including sample preparation, sample testing, result observations, calculations and documentation shall be given to the microbiologist by trained Microbiologist.
The qualification activity should includes:
- Practical demonstration of test method, result observations, calculations and documentation by trained Microbiologist.
- Testing a sample of previously passed batch including Control tests (e.g. negative test control, media control or control curve).
- Challenge test (unknown positive sample).
In case of microorganism challenge test (unknown positive sample), the microorganism isolated from the qualification test by the analyst shall be subjected to the identification test to identify contamination if any.
Microbiologist qualification shall be performed (but not limited to) in following tests, as applicable to the laboratory:
- Sterility test.
- Bacterial endotoxin test.
- Bioburden and Microbial limit test (MLT).
- Microbial identification using identification instrument, as applicable.
- Microbial culture handling.
- Growth promotion test.
- Media fill vials- visual inspections.
- Environment monitoring
In some cases it is acceptable to relate competence to a general technique or instrument being used rather than to particular methods.
Microbiologist under qualification should be able to reproduce pre-defined results or fulfill the acceptance criteria of the sample analyzed for particular test.
Based on the review of the analytical activities he/she performed which meets the acceptance criteria of the test, Microbiologist shall be certified as qualified/Dis-Qualified.
In case of dis-qualification, the entire activity shall be reviewed to identify the cause and retraining shall be given to the Microbiologist on the identified cause and requalification shall be performed.
Periodic requalification shall be performed at the frequency of once in a 3 year.In case, if the qualified microbiologist not perform the test, in which he/she was qualified for more than 6 months period, re-qualification shall be carried out before allowing for particular analysis.
Requalification may be carried out as a part of CAPA for non conformance related to analysis.
REFERENCES:
Not Applicable
ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
- Controlled Copy No. 01 : Head Quality Assurance
- Controlled Copy No. 02 : Head QC (Micro)
- Master Copy : Quality Assurance Department
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |