Checklist for review of microbiology data generated during the different tests of microbiology i.e. Antibiotic Assays, Particulate matter test, BET test, Preservative effectiveness testing ( Antimicrobial effectiveness testing), Microbial limit test (MLT), sterility, water analysis, and preservative effectiveness testing, Sterility testing. etc.
Checklist for Microbiological Analytical Data and Reports
Followings are the checkpoints during the review of microbiology data during various tests performed…
1.0 Product Information (Review of Microbiology Data) :
- Name of material (Brand name, Generic name)
- Pharmacopoeial status if any.
- Manufacturer supplier name.
- Batch No., A.R. No., Batch size.
- Mfg. Date, Exp. Date.
2.0 General Check (Review of Microbiology Data) :
- The Analytical method, effective date, revision number.
- Calibration status of Instrument/Equipment.
- Instrument/Equipment code No.
- Instrument/Equipment usage log entry.
- Name and grade of reagents used in the analysis.
- Solution code no.
- Balance ID used in the analysis.
- Sample weight.
- Test preparation.
- Dilution, sonication time,filter, centrifuge of sample as per ATP .
- Weight slip print out and any other print out with B.No. /A.R No. and signature of the analyst.
- Date of analysis.
- Countersignature where ever applicable.
2.0 General Check – MLT, Sterility, Water Analysis, and P.E. Testing :
- Media used (check against respective ATP/Pharmacopoeia).
- Media preparation date and its validity.
- Sterilization reference no. / lot of media.
- The pH of media.
- Autoclave /DHS starting and end time.
- Autoclave /DHS temperature.
- Incubator number, calibration status of the incubator.
- Incubation time, incubation temperature.
- Testing preparation vs. raw data.
Related: SOP For Microbiologist Qualification
- Type of method used.
- Weight of the sample.
- Dilution of the sample.
- pH adjustment of sample preparation, if any”.
- Entries in the respective logbooks.
- Daily observation and countersignature of the person who has observed.
3.0 Test – Microbial Limit Test (Review of Microbiology Data):
- Dilution factor.
- Result in CFU/plate or CFU /gram.
- Mean count of the duplicate plate and reporting count per g/ml
- Method type (filtration / pour plate).
- Additional testing, e.g. microscopic, biochemical and /or genotypic identifications.
- Raw data for associated environmental and personal monitoring (Investigation/manipulative controls).
4.0 Test – Sterility Testing (Review of Microbiology Data):
- Sample quantity against batch size.
- The volume of each container used for testing.
- Method used (filtration/direct inoculation).
- Observation of the tubes for growth/turbidity.
- Positive/negative controls.
- Manipulated negative control.
- Preparation date of tube and expiration date
5.0 Test – Water Analysis (Review of Microbiology Data):
- Sampling quantity for chemical analysis other than TOC.
- TOC analysis data review.
- Microbial analysis.
- Testing procedure vs. raw data, calculations, and results.
Related: SOP on Laminar Air flow (LAF) – Operation, Cleaning and Qualification
- Entries in instrument usage log book.
- Instrument code and calibration traceability in template/worksheet.
- Calibration of instruments.
- Sample hold time vs. analysis.
- Trending and conclusion.
- Positive and negative control results.
6.0 Test – Preservative Effectiveness Testing ( Antimicrobial effectiveness testing):
- Organisms used vs. recommended in the pharmacopeia.
- Use of preservative inactivator and concentration.
- Culture suspension preparation procedure and raw data.
- Amount of inoculum added.
- Dilution of inoculum added.
- Quantity of product used for testing.
- Raw data and calculations for periodic testing, at different intervals.
- Results and Conclusion as per ATP.
- Raw data for associated environmental and personal monitoring (Investigations/manipulative controls).
7.0 Test – BET test ( Bacterial Endotoxin Test):
- Make, expiration date and lot no. of CSE and lysate and LRW.
- Lysate sensitivity used.
- Qualification of lysate.
- Qualification of LRW.
- Sample dilution as per MVD.
- Certificate for compatibility of lysate with CSE.
- Added qty. of the sample, CSE, lysate, and LRW in test tubes.
- Reconstitution, storage, and destruction of lysate and CSE.
- Incubation condition (temperature and time).
- Equipment no.of heating block.
- Calibration status of the heating block.
- Validation of the test.
- Result of positive and negative control Vs. test procedure
8.0 Test – Area monitoring or Environmental Monitoring :
- Exposure time, sampling location, frequency, calculations and comparison with established limits, refer test as per MLT.
- Result of positive and negative control vs. test procedure.
- Equipment details and their calibration status.
- Plate counts, calculations and result data.
- Review in EM database ( electronic database to trend results)
- Trend data chart and conclusion.
9.0 Test – Particulate Matter Test (Review of Microbiology Data) :
- System suitability.
- The sample quantity and volume of air aspirated.
- Data interpretation for zone classification.
10.0 Test – Microbiological Analysis of Compressed Air :
- Sampling schedules
- Sampling locations, frequency, sample volume
- Result of the negative control (media sterility check)
- Incubation details (time / temperature)
- Equipment details and their calibration status
- Plate counts, calculations and result data
- Trend analysis and conclusions
11.0 Test – Microbiological Testing of Antibiotic Assays :
- Media used (check against respective ATP/Pharmacopoeia).
- Media preparation date and its validity.
- Sterilization reference no. / lot of media.
- The pH of media.
- Quality testing and release of culture media.
- Autoclave /DHS starting and end time.
- Autoclave /DHS temperature.
- Incubator number, calibration status of the incubator.
- Incubation time, incubation temperature.
- Testing preparation vs. raw data.
- Type of method used.
- Weight of the sample.
- Dilution of the sample.
- Sample extraction procedures
- Preparation and validity of the standard stock solution.
- Sample and standard dilutions.
- Raw data entries in respective logbooks/ worksheets.
- Equipment details- ID and calibration status.
- Daily observation and countersignature of a person who has observed.
- Plate reading, calculations, and conclusions.