Warning Letters Analysis

FIGEN YILMAZ
2 2
 + Attributable
Complete, By whom and when
was the action
Consistent, performed?
Enduring, If the record was
changed, by whom
Available and when?

Accurate Legible
The data should always
ALCOA+ The data should not be be recorded in a
handled without permanent and
documentation and the unchangeable
data should not be
environment where it
changed.
can be permanently
accessible.
Contem
ALCOA+
poraneous
Original The data should be
The data should be recorded
original or certified true consecutively with the
copy. date and time
information at the time
when the action is
performed.
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20.11.2018
 Warning Letter Analysis-Documentation
1.Documents taken out of the premises in an uncontrolled way. +
2.Quality records, chromatograms disposed +
3.Two different analysis certificates for the same product A
4.Back-dating on the records C
5.Missing signatures +
6.Using uncontrolled, sketchy notes L

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 Warning Letter Analysis Documentation
7. Inappropriate data corrections on the document L

8.Unrecorded customer complaints A

9.Differences between raw data and printed chromotograms O

10.Lack of QA and QP control for release data A

11.Missing or unclear information on the records +

12. Documents having in-accurate information on them. A

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 Warning Letters Analysis-Equipment

1. Missing equipment qualifications QS

2. User Requirement Specifications are not sufficiently determined
before investment of new equipment QS
3.Equipments which have been indicated as used in logbooks
but are not actually used A
4.Lack of authorization controls on the operating system and
software of devices such as GC, HPLC, KF. A

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Warning Letters Analysis-Lab Controls
1.Missing tests in finished product controls, product releases realized with
missing tests
+

2.Not having four eyes controls on the test results A

3.Performance of trial injections from samples, A

4.The out of limit results from trial sample injections turning into within limits
results in actual analysis and complying sample reporting of the records.
A

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 Warning Letters Analysis-Lab controls

5. Not performing investigations for nonconforming results A

6.A number of analytic results in the batch records being identical O

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 Warning Letters Analysis-Personnel

1. Incorrect information sharing with auditors Q

C
2.Inconsistent and incredible responses of the personnel which
are tailored based on auditor's request Q
C

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 Warning Letters Analysis-Data Access
1. The absence of applications for employees to access
regulatory data A
2. The inadequacy of the controls preventing data from being
deleted or changed A
3. No access to past original raw data
O
4. Employees sharing common passwords, no personal passwords
A
5. Gaps in audit trail function, lack of information concerning
who, when, why, what, where and how. A

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Warning Letters Analysis-Data Access

6.Login into BMS and PMS systems without password, A

system responsibilities not assigned

7.Audit Trail records are not reviewed in the process of batch

records review and release of products without audit trail A
controls.

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