GMP Inspection (Audit)

Quentin Blades
QRB Consulting
GMP Inspection (Audit) Principles

Inspection principles are to achieve an outcome allowing

auditor to:
Assess manufacturers compliance with the regulatory
requirements
Systematically and objectively collect and analyse sufficient
relevant evidence to allow auditor to make an assessment of
the Manufacturers conformance with requirements
Report Non-conformances observed during the audit in the
GMP Audit Report
Snap shot of GMP activities in the company
Not possible in an audit with a limited timeframe to identify
every area requiring attention, so apply risk assessment
Inspection Principles

Non-Conformance ratings:
MINOR non-conformance minor or less serious
non-conformance which is unlikely to pose a risk to
product quality
MAJOR non-conformance failure to satisfy a key
or mandatory requirement and/or one which may
pose a risk to product quality
CRITICAL non-conformance a major non-
conformance which poses a risk to users and must
be corrected immediately
GMP Inspection Principles

To systematically and objectively collect and

analyse sufficient relevant evidence to allow
auditor to make an assessment of the
Manufacturers conformance by:
Questioning of site personnel and discussion
During walk through
During document review
GMP Inspection Principles

DOs and DONTs

DOs at Inspection (Audit)

DOs upon arrival at company:

Introductions (check that the manufacturer is correct)
Opening meeting
Participate in OH&S presentation by client regarding
Safety
emergencies, etc
Discuss audit programme including comfort breaks
and refreshments
DOs at Inspection (Audit)

Record the audited element and associated

notes
Record details of the company dates, site, staff
Record observations

Do annotate observations, reminders, prompts,

follow-ups, etc
Allows comprehensive and accurate preparation of
audit report for client, without resorting to
recollection of memory
DOs at Inspection (Audit)

Non-conformances - discussed with

personnel at time of observation
Daily summary to be provided
Closing meeting and provide summary of
observations
Sign for any documents taken during the
inspection (as uncontrolled documents)
DONTs at Inspection (Audit)

Arguing with a TGA, FDA, inspector

is unlikely to get you anywhere. As a
colleague of mine expressed it, it is
like wrestling with a pig in mud and
you soon realise that the pig is
enjoying it.
DONTs at Inspection (Audit)

DO NOT:
take photographs
use tape recorders or other electronic recording
equipment
request signing of statements from company
employees
request for review of internal audit reports (?)
request access to computer databases
Traits & Inspection techniques for
Inspection

Desirable traits and inspection techniques:

Introduce yourself during opening meeting
ALWAYS be polite, patient and professional
DONT use a tone that may be perceived as
accusatory or confrontational
DONT become emotional and remain objective
When asking for information, phrase questions
such that you are NOT providing the answers
Interviewing & Questioning techniques

Dont ask YES/NO questions

If you have to, be judicious when to and limit
asking of yes/no questions
Listen attentively and give auditee time to talk
Do not let your opinions or expectations
influence what you hear
If you receive answers that fully explain or
provide information needed, stop there
Interviewing & Questioning techniques

If not receiving information needed, then

start using probing questions.
When appropriate, ask to see examples of the
information provided or supporting documentation
Ask direct questions and if a general
answer is given without specificity:
Then request an example
Or ask for supporting documentation for the
response
Interviewing & Questioning techniques

Determine employees function, then ask for:

Pertinent procedures
Forms and data relevant to tasks
Training records to support tasks done
If you do not believe information received is
accurate, then:
Rephrase the question
Or ask the same question to a different employee
Interviewing & Questioning techniques

Do not criticise an individuals response even

if you believe that it is not satisfactory
Determine if an unsatisfactory response is
due to:
Result of unsatisfactory training
Result of an inadequate procedure used
Lack of management involvement
Listening techniques

Auditees are generally nervous, try to put them

at ease by smiling and introducing small talk
Listen attentively and people will volunteer more
information than originally requested
Give auditee time to respond
Practice active listening by asking
Questions at appropriate times
Indicate that you are listening by interjecting at
appropriate times
Add small comments like I see
Listening techniques

As information will be received verbally, it

is important to:
Confirm the information collected against
documentation
Conduct field verification (observations)
Complementary/Herbal Products

Besides standard walk through checks and

document checks, pay particular attention to:
Evidence of GMP agreement, especially QC
testing and release for supply
QC testing of active ingredients
On-going stability being done to support
declared shelf life and storage condition
Compliance with the BP, USP or EP and
TGOs 77 and 78
Complementary/Herbal Products

PQRs
Training records