HANDLING OF OUT OF SPECIFICATION RESULTS IN MICROBIOLOGY

1.0 OBJECTIVE
To lay down a procedure for handling of raw materials Samples and Finished Products out-of-specifications test results in microbiology.
2.0 SCOPE
This SOP is applicable to Quality control Department, Formulations Units
3.0 RESPONSIBILITY
Executive
4.0 ACCOUNTABILITY
Departmental Head
5.0 PROCEDURE
5.1 Any out-of-specification test result shall be investigated and documented. The investigation report shall include,
5.1.1 Errors in sampling, handling and storage of sample.
5.1.2 Error in Analysis.
5.2 In case investigation reveals that sampling is one of the reason for out of specification result, the repeat analysis shall be done on re-sample.
5.3 In case investigation reveals that out-of-specification results is solely due to analytical error, the repeat analysis shall be performed on same sample.
5.4 If repeat analysis result is found within specification, following step 5.2 or 5.3 then the sample shall be approved. If the analysis result is found out of specification, the sample shall be rejected.
5.5 When investigation does not reveal any abnormalities, due to assignable cause, then repeat analysis shall be performed by following procedure :
a. Same sample shall be re-analyzed. (i.e., Analysis shall be done on a second aliquot from the same portion of sample that was the source of the first aliquot or Analysis shall be done on portion of the same larger sample previously collected for Laboratory purpose.)
b. Analysis shall be done in triplicate by two analysts . Out of two analysts one may be the original analyst.
5.6 The original out-of-specification test result shall be ignored if,
a. Each test result is within specification.
b. Results of both the analyst are comparable.
5.7 The original out-of-specification test result shall not be averaged along with repeat analysis results.
5.8 If repeat analysis results do not meet the specification the batch/ packed order shall be rejected.
5.9 Annexure shall be used for documentation of investigation.
5.10 In case of rejection of samples, thorough investigation shall be done involving Production Manager, Product Development Manager and Head - Quality Assurance / Departmental Head and the same shall be documented.
5.11 The investigation shall be completed within 30 days after QC rejection of the sample. Investigation report shall outline the corrective actions necessary to save batch to prevent similar reoccurrence.
5.12 The investigation shall also be extended to other batches and products possibly affected due to operator error or malfunctioning of equipment.