1.0 OBJECTIVE
To describe the procedure for validation of microbiologist.2.0 SCOPE
This SOP is applicable for the validation of microbiologist.3.0 RESPONSIBILITY
Officer/ Executive - Quality Control4.0 ACCOUNTABILITY
Manager -QC5.0 PROCEDURE
5.1 Samples of known analytical results shall be identified by Quality Control Manager for analysis in triplicate with three different identification no.6.2 The analytical result(s) of sample(s) along with acceptable limit(s), AR no., and code no. shall be recorded by Quality Control Manager in a register maintained for this purpose.
6.3 All the coded samples shall be issued to Microbiologist on the day of Analysis along with the necessary information required for the analysis.
6.4 The Microbiologist shall be validated for microbial limit tests, sterility & endotoxin test.
6.5 The results of Microbiologist shall be checked for cGLP compliance and compared with expected values.
6.6 The capability to perform tests by Microbiologist shall be considered satisfactory if the results reported by the Microbiologist are within the acceptable limits as per annexure-1.
6.7 The Microbiologist shall be revalidated once in a period of two years. A new Microbiologist shall be validated first time within a year of joining.
6.8 The details of analysis along with comments of Quality Control Manager shall be filed in training file of Microbiologist.
6.0 ABBREVIATIONS
6.1 SOP - Standard Operating Procedure6.2 No. - Number
6.3 QA - Quality Assurance
6.4 NA - Not Applicable
ANNEXURE-I
TEST ACCEPTANCE LIMIT
S.No.
|
Test
|
Acceptance Criteria
|
1.
|
Microbial limit test
|
|
a.
|
Total Bacterial & fungal count
|
Average Recovery should be in the range of 80-120% of initial value.
|
b.
|
Pathogen test
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Results should be repeated as that of initial analysis
|
2.
|
Sterility test
|
Results should be repeated as that of initial analysis
|
3.
|
Bacterial Endotoxin
|
Results should be repeated as that of initial analysis
|
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