Preparing for your

Microbiology Laboratory

to be Audited

Julie Roberts

Overview

Context of the audit

Involvement of the lab personnel

Quality Systems overview

Touring your lab

Preparing documentation

The limitations of the audit process

An audit is only a “snap-shot” in time

Auditors want to see a Lab that :

•Is in control

•Has confident and knowledgeable staff

•Understands the company’s processes

and systems

•Is compliant against regulations and

company requirements

•Can produce reliable and dependable

results

Understanding the audit scope & purpose

Having a clear understanding of the reason for the audit

and purpose helps defines the objective of the audit and

defines the audit boundary

For Cause

Initial GMP audit

Routine audit

Follow-up GMP audit – follow upon CAPAs

Specific method qualification/method transfer

Relevance of the Micro Lab within the audit

For Cause – limited scope with in-depth review, shared

interest to understand the cause and ensure correct

CAPAs are in place. Hard not to feel defensive, and

violated. Can assist you in your investigation

Regulatory Audit – Micro lab likely to be a small part of

a bigger audit, some aspects of QMS review may be

covered elsewhere. All data can be accessed

Contract manufacturer – Micro lab likely to be a small

part of a bigger audit, some aspects of QMS review may

be covered elsewhere. Client specific data

Relevance of the Micro Lab within the audit

Qualification – focus on QMS and ability to present a

holistic view of your lab. Micro may be the focus of the

audit. Limited amount of data since no client specific data

Self inspection – unlimited access to data, beware of

familiarity & conflict of interest

Contract test lab – strong focus on your lab

Defining the audit standards

Understand what standards the auditors will be using to

assess you against – can vary according to type of audit

Regulatory guidelines (EU GMP, FDA CFR, PIC/S,

WHO, ISO etc..)

Quality agreement

Customer specified test methods

Pharmacopoeial methods

Marketing Authorisation

Complaints

Deviations and investigation

Selecting the audit team

Not always possible to pick who the auditor speaks to,

but……… you can still be prepared

How confident are your team?

Have your team faced audits in

the past?

Who are your SMEs?

Would you put them in front of an

auditor?

Who needs some practice and

more confidence?

Involvement of the Micro Lab via……

Raw material/ finished product sampling & testing

Environmental monitoring

Equipment qualification (BI’s, filters, rinse samples swabbing etc..)

Aseptic training of operators/cleaners/samplers

Oversight of media fill operations

Process validation & cleaning validation

Cleanroom qualification

Preparation of culture media,

Involvement in site deviations and investigation

Qualification/routine testing of utilities (water, gases, steam)

Preparing for the audit

Review your lab against the six quality systems

Materials System

Quality Management System

Facilities and Utilities System

Production System

Packaging & Labeling System

Laboratory System

Materials system

Look at your lab as a mini warehouse system

What comes in ?

What goes out ?

How are materials receipted/ labelled and controlled?

How do they move around the lab? (chain of custody)

Stock rotation?

Incoming QC testing or approval of materials for use

Destruction of materials after use/expired

HOT TOPIC

Production System

Links to Microbiology from monitoring done in

production

Environmental monitoring

Personnel monitoring

Rinse samples

Rinse swabbing

BI’s for qualification of aseptic processes

Cleaning agents viewed on tour

Equipment Cleaning validation

Process validation

Media Fill Batches

Quality System

Deviations

Change controls

Out of specification results/Atypical results

CAPAs

Production issues involving microbiology

Training programme

Quality metrics

Data Integrity

Compliance with site policies as well as lab procedures

HOT TOPIC

Facilities and Equipment System

External systems – utilities (PW, WFI, Steam, Gases)

Are these qualified?

Are you confident you could present your portion of the

data?

As a microbiologist do you understand these systems?

Laboratory equipment – incubators/ stability chambers/

identification systems/ plate readers/ pipettes/ water

baths/ air samplers (viable/non-viable) etc..

Laboratory facility – cleanroom qualification/ flow of

materials around the lab, segregation of clean/dirty

operations/ secure access to the lab

Laboratory System

Materials system aspects

Quality System aspects

Media preparation & QC

Identification of organisms

Method qualification & validation

Interpretation of results and data generated

Sampling/testing plans

Averaging/rounding of data

Control of standards/cultures etc..

Packaging and Labelling System

Cleaning of packaging lines with verification of

microbial cleanliness

EM for packaging rooms (ointments/creams/tablets)

Audit Agenda

If you have received an agenda, study it.

Taking on board the six quality systems, how many

parts could link back to your lab?

Get those document packages and data ready

What have been the key events in the past two years

for micro?

New lab/ upgrade

New equipment

Media fill failures

Mould contamination

etc.

Facility Tour

First impressions count

A picture paints a 1000 words

Have someone from another

department take a lab tour- what is

their perception?

If you know the tour time, you’ll

know what type of activities will be

going on at the time- show the lab

at its best

Facility Tour

Check logbooks, temperature charts etc.. in use – how

much data are you giving your auditor?

One month, 6 months, 2 years?!

Control the size of your logbooks

Drawers, cupboards, lockers – what do they contain?

Are you nervous of the auditor looking inside?

Diaries, laboratory notebooks, personal notebooks

Is data being recorded in them?

Weighing results, counts, calculations, batch

numbers etc.

View each others- how is your notebook perceived?

Presenting Documentation

Confidence in explaining a

package makes a huge difference

Understand your own data and

documentation

Practice presenting to the team if

needed

Presenting Documentation

Key investigations/deviations

Review the list and their status – any overdue?

Prepare a folder if necessary for each key

deviations containing with all the relevant parts –,

deviation, investigation report, evidence of

retraining, evidence of CAPA completion

Major change controls

Folder containing original change control, executed

task, evidence of completion, evidence of

effectiveness checks

Use schematic overviews as an aid

Presenting Documentation

Training files

If HR own them, then request before the audit and

do a review yourselves.

Are they complete, accurate, reflective of all the

training done?

Training packages- are they available, organized,

easy to follow, up to date?

Retraining- has it been done in accordance with

policy?

Qualification Packages

Ensure you have all the required parts

VMP/URS/ FS/ DQ/ OQ/ IQ/ PQ + CSV where required

Packages may be old – its no excuse for bits being missing!

Understand how each folder of data is organised

Study it & revise it

Be confident in explaining the package

Know how its laid out

Know where the component parts are

Know where the raw data is/how it links to the reports

Know what the aim of the data package was (comparison study/

qualification/ validation/ revalidation)

Qualification Packages

Consider an index – especially if there are several

binders

Ensure you have a copy of the change control (and

deviation/investigation) with the binder

Summary reports

Executed protocols

Raw Data

Use index tabs if it helps

If packages are found lacking- update with a

retrospective report to explain any issues/gaps

Qualification Packages

For packages older than three years

Conduct and independent review

Do they meet todays expectations/

requirements?

Are they scheduled for revalidation/

re-qualification?

You may not be able to repeat the

study in time for the audit,

You can approve a schedule to repeat

the study

In summary

Know the context of the audit and context of your lab

within the audit

A picture paints 1000 words

Understand the key areas to be requested

Prepare the documentation packages

Revise your documentation and practice presenting

Questions?