SOP for Validation or Qualification of Microbiologist or Analyst: Pharmasopcorner

Standard Operating Procedure for Validation or Qualification of Microbiologist.

1.0 Purpose:
To lay down the procedure for qualification of microbiology analyst for the performance verification.

2.0 Scope:
This procedure is applicable for verifying the accuracy of analysis and ensures the analysis results are within acceptable tolerance for variance for all microbiologists involved in testing of water, raw materials and finished products in Microbiology lab.

3.0 Responsibility:
Microbiologist / Designee:
•To perform the test as per given sample.

Head/ Designee - QC:
•To implementation and ensure compliance of SOP.

•To carry out the qualification of analyst.

•Interpreting the results obtained and maintaining the raw data thereof.

•To getting Approvals of results from Head QA

Head/ Designee - QA:
•To approved the microbiologist as per criteria.

•To approve, implement and ensure compliance of SOP.

4.0 Procedure

4.1 QC Head/designee is at random pick up samples from any approved finished product/ raw material or water for qualification of microbiologist.

4.2 The analyst is to carry out the analysis on the given sample in duplicate.

4.3 The analysts skills, GLP adherence and SOP/STP compliance is to be checked by the assigned supervisor who records the values/results checked during analysis.

4.4 The average value of the duplicate results is to be compared with the senior result value of analysis for qualification.

4.5 The difference in results of analysis between new microbiologist and expert microbiologist is to be within the acceptance criteria.

4.6 Details of acceptance criteria of each test as per mentioned below table (Microbial limit test for finish product / raw material / water).

1. Total Aerobic Bacterial Count - NMT 10 CFU

2. Total Yeast & Mold Count - NMT 5 CFU

3. Pathogen - Must be Match

4.7 Make Summary report of microbiologist.

4.8 If difference is observed more than acceptance criteria, then give more training to new microbiologist for handling of instruments, preparation of samples and analysis by the QC Head/designee in order to upgrade his knowledge to the acceptable level.

4.9 Significant variance with reference to original values is to be investigated and corrective and preventive action initiated.

4.10 In case of any deficiency/error observed during the performance of the test, the QC Head/designee is making a note of it and discuss/explain the same with the concerned analyst after completion of the analysis. This is documented at the time of verifying the results of the analysis.

4.11 Each analyst is revalidated when analyst on every two years ±30 days or leave for more than one month.