MICLAB-130 Handling of Test Sample in Microbiology Laboratory

5.1 Sample Receipt and Logging

5.1.1 Enter sample information into the Microbiological Sample Logbook

5.1.1.1 Enter sequential request number.

5.1.1.2 Date Sample Logged.

5.1.1.3 Sample details:  description, batch number, sample type, test required.

5.1.2 Place delivered sample in appropriate to test location within laboratory based on sample type:  raw material, bulk/finished product, stability sample.

5.1.2.1 Water samples or samples requiring refrigeration, are to be placed in sample refrigerator.

5.1.2.2 Controlled samples are placed in the secure storage locker.

5.2 Sample Testing

5.2.1 Update sample information in Logbook:  enter date sent to Micro Laboratory (this indicates the date testing commences).

5.2.2 Generate protocol according to appropriate SOP

5.2.3 Test samples per the appropriate Microbial Test Method (MTM) maintained within the Laboratory.

5.2.4 Documentation of raw data in Laboratory Notebook

5.2.4.1 Test Being Performed

5.2.4.1.1 E.g. (Req # – TPC, Y/M)

5.2.4.2 MTM’s used for testing

5.2.4.3 Scale ID

5.2.4.4 Media Lot numbers used

5.2.4.4.1 If more than one lot of the same media is used on a given day indicate which request utilized a given media type.

5.2.4.5 Dilution used

5.2.4.5.1 If more than one dilution is used indicate which request utilized the particular dilution.

5.2.4.6 Sample Information

5.2.4.6.1 Assigned request number(s) from section 5.1.1.1.

5.2.4.6.2 Name and Lot number of material

5.2.4.6.3 Weight of sample

5.2.4.6.4 Dilution plated

5.2.5 Documentation of raw data in EMIS database

5.2.5.1 Enter in comments section of EMIS protocol.

5.2.5.1.1 Assigned request number from section 5.1.1.1.

5.2.5.1.2 Stability samples, enter time point information:

5.2.5.1.2.1 e.g. “Stability – 30/70/48” which translates to 30ºC/70% Humidity/48 Months

5.2.5.1.3 Make reference to Microbiology Laboratory Notebook e.g. MIC 1/2008.

5.2.5.2 RM/BM Lot Number

5.2.5.3 Sample tested by and read by

5.2.5.4 Incubator ID, temperature, and incubation dates.

5.2.5.4.1 Incubation start date is equivalent to date tested.

5.2.6 Place sample into appropriate “Tested Samples” area.

5.2.6.1 Controlled samples are placed back in the locker.

5.3 Testing Completion

In case of all results meet test

5.3.1 Enter results and supplemental data into appropriate database as results are available.

5.3.1.1 Proceed to section 5.3.6 if a result is determined as suspect.

5.3.2 Record is “Completed” after all results have been entered into.

5.3.3 Record is “Reviewed and Approved” by Manager or designee.

5.3.4 Distribute results.

5.3.4.1 Raw materials:  Enter results onto Raw Materials Specification Test Report.

5.3.4.2 Finished/Bulk Products:  Enter results onto the Finished Product Specification Test Report.

5.3.4.3 Stability samples:  print of summary and deliver to Stability Laboratory.

5.3.5 Discard samples after release as per appropriate procedure.

In case of suspect results or results do not meet test

5.3.6 Place test sample into “Suspect Do Not Discard” section of samples tested area.

5.3.7 Initiate Laboratory Investigation for Out of Specification results as necessary as per appropriate procedure.

5.3.8 At completion of Laboratory Investigation and after any retesting, if required, has been performed proceed back to section 5.3.1.