无菌取样及微生物检测的审计项目

Microbiology-Audit-Checklist-PFF.doc

Microbiology Audit Checklist: Pre-final Filtration Inprocess Bioburden Test Date of audit:___________________

Auditor:___________________

Time of audit:__________________ Staff member audited:________

Part A: Production Sampling

Containers

· Which containers will use for sampling?

· Why have you selected those containers?

· How can you verify that those containers are sterile?

· Where do you check the expiry date of the sample container?

Sampling Plan

· Which batch processing record was used?

· How did you know which batch number to assign to the sample?

· Which procedure will use for sampling?

Sampling procedure

· At what time during the filtration is the sample taken?

· Observe aseptic technique

· At what stage would you change your gloves?

· Explain how you will take a sample in order to avoid contamination? · What happens if the filter is blocked?

· What happens if you need to make an intervention during sampling? · How do you avoid adventitious contamination when sampling?

· What will you check for in order to ensure that your sampling container is in a satisfactory condition?

· Where do you note who took the sample and at what time?

Part B: Post-sampling / Transportation

· What will use to transfer the sample back to the laboratory?

· What is the storage temperature for the sample?

· How long can a sample be left for between the time of sampling and pre-test incubation?

· Why does this time matter?

· Where will you store the sample?

· How do you ensure that QC are aware that there is a sample for testing?

Part C: Sample collection

· Which procedure do you use for sample collection?

· Where do you collect the sample from?

· At which time do you collect the sample?

· How do you check the sample identify?

· Where do you record that the sample has been collected?

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