To lay down the procedure for Validation of Microbiologists.
2.0 SCOPE
This SOP is applicable for the validation of microbiologists in the QC department.
3.0 RESPONSIBILITY
3.1 Jr. Microbiologist and above shall be responsible for the preparation of this SOP.
3.2 Sr. Microbiologist shall be responsible for the execution and checking of this SOP.
3.3 Manager QC shall be responsible for the approval of this SOP.
3.4 HOD shall be responsible for the authorization of this SOP.
4.0 ACCOUNTABILITY
Sr. Microbiologist
5.0 PROCEDURE
5.1 Samples of known analytical results shall be identified by Sr. Microbiologist and verified by Quality Control Manager for analysis.
5.2 The analytical result(s) of the sample(s) along with acceptable limit(s), AR no. and code no. shall be recorded by Sr. Microbiologist & Quality Control Manager in a register maintained for this purpose.
5.3 All the coded samples shall be issued to Microbiologist on the day of Analysis along with the necessary information required for the analysis.
5.4 The Microbiologist shall be validated for the microbial limit test.
5.5 Analyst shall perform the analysis in triplicate coded I, II, III.
5.6 The results of the Microbiologist shall be checked and compared with expected values as per annexure-III.
5.7 The capability to perform tests by the Microbiologist shall be considered satisfactory if the results reported by the Microbiologist are within the acceptable limits as per annexure-II.
5.8 The details of the analysis along with comments of the Quality Control Manager shall be recorded.
5.9 In case of failure to comply with the acceptance criteria for validation the analyst shall be retrained/re-evaluated.
5.10 Frequency: A new Microbiologist shall be validated for the microbiology testing within a year of joining.
6.0 REFERENCES
N.A
7.0 ANNEXURE
|
Annexure No. |
Title of the Annexure |
Format No. |
|
Annexure I |
Sample Allotment Sheet For
Microbiologist Validation |
F……………………… |
|
Annexure-II |
Acceptance Criteria |
F……………………… |
|
Annexure III |
Protocol for the validation of the
Microbiologist |
F……………………… |
8.0 ABBREVIATIONS :
SOP: Standards Operating Procedure
QC: Quality Control
HOD: Head of the Department
QA: Quality Assurance
QCD: Quality Control Department
QAD : Quality Assurance Department
N.A : Not Applicable
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