1

0 points
FDA inspectors can review or copy internal audit reports, Corrective Action Requests
(CARs) or Quality Review Board (QRB) meeting minutes.
Your Choice
True
2
1 point
Which of the following is a US FDA enforcement action?
Your Choice
All of the above
3
1 point
A competent authority:
Your Choice
Nominates auditors
4
0 points
Under what circumstances will a GMP inspection in Japan be waived?
Your Choice
The product is approved in the EU.
5
0 points
For what coordination is EMA responsible?
Your Choice
All activities outside the EU
6

1 point
ISO is an organization that:
Your Choice
develops international standards
7
1 point
Management determination of inspection restrictions will consider which of the
following?
Your Choice
All of the above
8
1 point
What are the primary objectives of the Pre-Approval Inspection program?
Your Choice
All of the above
9
0 points
The Joint Audit Program of the EU validates and verifies that the appropriate
provisions of the European directives have been incorporated into national laws.
This would cover which of the following?
Your Choice
Quality system, including implementation of Compilation of Community Procedures
10
1 point
It is permissible to discuss information outside the scope of the audit if an inspector
asks.
Your Choice
False

11
0 points
In the US, FDA guidance documents establish requirements and can be referred to
as the justification for an inspectional observation.
Your Choice
True
12
1 point
Under what circumstances may US FDA access records that are exempt from review
under CPG Sec. 130.300?
Your Choice
All of the above
13
0 points
The Investigations Operations Manual (IOM) is the primary guidance document on
FDA inspection policy and procedures for field investigators and inspectors.
Your Choice
False
14
1 point
Which of these activities does the Australian TGA not perform?
Your Choice
Test food.
15
1 point
Compliance Program 7356.002 incorporates the systems-based approach to
conducting an inspection and identifies six systems in a drug establishment for
inspection.

Your Choice
True
16
1 point
A receipt for items confiscated or taken by an inspector should include:
Your Choice
All of the above
17
1 point
Inspectors do not require escorts through the facility when conducting an onsite
inspection.
Your Choice
False
18
0 points
If an auditor finds that the process is within specification, but operating at close to
the threshold for acceptance, it would be appropriate to bring the issue to
managements attention by writing a nonconformance.
Your Choice
True
19
1 point
The ________ summarizes the activities performed and provides a high-level
discussion of the audit findings.
Your Choice
audit report
20
1 point

In Europe, Good Distribution Practice (GDP) is associated with which of the

following?
Your Choice
Good Manufacturing Practice (GMP)
21
1 point
ICH standards are recognized worldwide.
Your Choice
True
22
0 points
What would a well-written audit instruction include?
Your Choice
A and B
23
1 point
Which of the following statements about auditor independence is true?
Your Choice
Auditors may perform an audit only when they are independent of the activity being
audited.
24
1 point
Which of the following statements is false?
Your Choice
Auditing is not usually announced in advance.
25
1 point

FDA for-cause inspections are usually conducted as a result of:

Your Choice
All of the above
26
0 points
Which is not true?
Your Choice
GCP inspections are performed by the EMA.
27
0 points
Guidance and standards have the effect of law in EU Member States.
Your Choice
True
28
1 point
Compliance Program 7346.843 (Postapproval Audit Inspections) is designed to audit
for changes in the production and control practices that occur after approval and to
confirm that the approved applications have been supplemented appropriately to
reflect those changes.
Your Choice
True
29
1 point
Which of the following is true in regard to the Pharmaceutical Inspectorate as part of
PIC/S?
Your Choice
All of the above
30

0 points
When an inspection report is issued in the EU, it should be given to the:
Your Choice
Notified body