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?