SECTION III

DOCUMENT/REPORT EXAMPLES

© 2000 by CRC Press LLC

 Section III-1

QUALITY ASSURANCE DOCUMENTS

© 2000 by CRC Press LLC

© 2000 by CRC Press LLC

NORTHERN RESEARCH, INC. Page 1

QUALITY ASSURANCE Status: March 27, 2000

PROJECTIONS:

QAU Inspections I MASTER SCHEDULE

Protocol Issued P

Final Report R

Interim Report r

2000 2001
Test Study Test Study Study Nature of Study and Current
Article Identity System Initiation Director Status/Final Report M A M J J A S O N D J F
AC-123 99-322 Mouse 01/07/00 Smith Acute PO Tox/In-Preparation R
AC-123 00-107 Rat 03/09/00 Robbins One-Month IV Tox/In-Process I I R
BD-149 99-257 Dog 09/19/99 Robbins Three-Month IV Tox/
Issued 3/26/00 R
BD-149 99-314 Monkey 12/17/99 Williams Six-Month IV Tox/In-Process I I R
RS-160 00-059 Rat 03/25/00 Smith Acute IV Tox/Protocol P I R
RS-160 00-103 Rat 04/09/00 Smith One-Month IV/Protocol P I R
TM-172 99-337 Salmonella 03/05/00 Gentry Ames Test/In-Preparation I R
VW-178 99-157 Dog 08/20/99 Robbins Twelve-Month Diet/In-Process I I R
ST-205 98-145 Mouse 08/06/98 Williams 2-Year Carcinogenicity Diet
In-Process r I I I I
ST-205 98-147 Rat 09/20/98 Harris 2-Year Carcinogenicity Diet
In-Process I r I I I
WS-310 99-258 Dog 10/02/99 Anderson Three-Month PO Tox/In-Preparation R
 NORTHERN RESEARCH, INC. Version 1
QUALITY ASSURANCE

STUDY INSPECTION RECORD

Study Title: Three-Month Intravenous Toxicity

Test Article: BD-149
Study Identity: 99-257
Study Species: Dog
Route: IV
Study Director: G. Robbins, Ph.D.
Study Inspection Signature/ Inspection Corrective Action
Phase Dates Date Report No./Date Acceptance Date
Initiation 9/19, 20/99 A.D. Moulchin
9/20/99
9/24,25/99 A.D. Moulchin
9/25/99

In-Process 10/8, 15–17/99 A.D. Moulchin

10/17/99
10/23–25/99 A.D. Moulchin 99-093 10/25/99 11/6/99
10/25/99
11/12–15/99 A.D. Moulchin
11/15/99

Completion 12/17–20/99 A.D. Moulchin 99-112 12/20/99 1/8/00

12/20/99
1/13,14/00 A.D. Moulchin
1/14/00
2/5/00 A.D. Moulchin
2/5/00

Reporting 2/28/00 A.D. Moulchin

2/28/00
3/4–6/00 A.D. Moulchin
3/6/00 00-027 3/6/00 3/20/00

© 2000 by CRC Press LLC

 NORTHERN RESEARCH, INC. Version 2
QUALITY ASSURANCE

STUDY INSPECTION RECORD

Study Title: Three-Month PO Toxicity

Test Article: WS-310
Study Identity: 99-258
Study Species: Dog
Route: PO
Study Director: J. B. E. Anderson, Ph.D.
Study Inspection Signature/ Inspection Corrective Action
Phase Procedure Dates Date Report No./Date Acceptance Date
Initiation PRO 10/2/99 P. Verke
10/2/99
AWS 10/2/99 P. Verke
10/2/99
FOR 10/9/99 P. Verke
10/9/99
In-Process AWS 10/7/99 P. Verke
10/7/99
DOS 10/9/99 P. Verke 99-097 10/9/99 10/17/99
10/9/99
FOR 11/12/99 P. Verke
11/12/99
BCN 12/2/99 P. Verke
12/2/99
OBS 12/6/99 P. Verke
12/6/99
DOS 12/10/99 P. Verke
12/10/99
Completion NEC 1/2, 3/00 P. Verke
1/3/00
CCH/HEM 1/2,7/00 P. Verke 00-002 1/7/00 1/23/00
1/7/00
MJC 2/19/00 P. Verke
2/19/00
Reporting RPJ 4/7-9/00 P. Verke
4/9/00
4/16/00 P. Verke
4/16/00 00-017 4/16/00 4/27/00

© 2000 by CRC Press LLC

 NORTHERN RESEARCH, INC.
QUALITY ASSURANCE

INSPECTION REPORT

W. Harris, PhD
To: ______________________________ K. Bellows, DVM
and ________________________
STUDY DIRECTOR
______________________________ MONITOR
________________________
Please respond to the observation below, and return this report to the
Quality Assurance Unit by 9/6/99.
Report Number: 99-092
__________________________
Study Number: 98-147
__________________________ Page: 1 of 1
__________________________
Test Article: ST-205
__________________________ Date: 8/6/99
__________________________

This is a CONFIDENTIAL legal document that is to be maintained by Quality Assurance for the pe-
riod of time as prescribed by the Good Laboratory Practice Regulations.

STUDY PHASE(S) INSPECTED INSPECTION DATE(S)

Initiation:
In-Process: ✓ 5/24; 6/12, 20; 7/8; 8/2/99
Completion:
Reporting:
B. W. Herrick B. W. Herrick 8/6/99
OBSERVATION: The scale used in measuring body weights had an expired calibration date. Weigh-
ings were done 8/2/99; the labeled calibration expiration date of this scale, Asset
#434, was 7/25/99.
RESPONSE: All the scales and balances within this facility are in a scheduled calibration
program. The Calibration Record for the above scale indicates that it was calibrated
on 7/24/99; however, the calibrator had failed to replace the calibration tag with
one having the correct information. Metrology had been contacted and will make
the correction.

Prepared By: H. James Date: 8/8/99

Approved By: K. Bellows Date: 8/9/99
Proposed Completion Date(s): 8/14/99
Study Director: W. Harris Date: 8/12/99

QAU REVIEW:
Action Plan Acceptance Date: August 13, 1999
By: B. W. Herrick
Completed: 8/19/99

© 2000 by CRC Press LLC

 NORTHERN RESEARCH, INC.

QUALITY ASSURANCE UNIT STATEMENT

Periodic Inspections of Study Number 99-257 entitled Three-Month IV Toxicity Study of BD-149 in
Dogs were conducted on all phases by the Quality Assurance Unit of Northern Research, Inc.

The study was inspected on the following dates:

September 19, 20, 24, 25, 1999

October 8, 15–17, 23–25, 1999
November 12–15, 1999
January 13, 14, 2000
February 5, 2000
February 28, 2000
March 4, 6, 2000

Results of inspections were reported to Management and the Study Director on 10/25, 12/20/99, and
3/6/00.

To the best of the signator’s knowledge there were no significant deviations from the Good Laboratory
Practice Regulations that affected the quality of integrity of the study.

James A. Kensington
______________________________ 3/6/00
__________________________
James A. Kensington Date
Manager, Quality Assurance

© 2000 by CRC Press LLC

 Section III-2

INSPECTION REPORT EXAMPLES

© 2000 by CRC Press LLC

 NORTHERN RESEARCH, INC.
QUALITY ASSURANCE

INSPECTION REPORT

J. C. Smith, PhD
To: ______________________________ W. C. Jones, DVM, PhD
and ________________________
STUDY DIRECTOR
______________________________ MONITOR
________________________
Please respond to the observation below, and return this report to the
Quality Assurance Unit by 4/27/00.
Report Number: 00-019
__________________________
Study Number: 00-059
__________________________ Page: 1 of 1
__________________________
Test Article: RS-160
__________________________ Date: 3/26/00
__________________________

This is a CONFIDENTIAL legal document that is to be maintained by Quality Assurance for the pe-
riod of time as prescribed by the Good Laboratory Practice Regulations.

STUDY PHASE(S) INSPECTED INSPECTION DATE(S)

Initiation: ✓ 3/25/00
In-Process:
Completion:
Reporting:
A. V. Moulchin A. V. Moulchin 3/26/00
OBSERVATION: The study protocol did not include the following information as required by the
GLP (58.120):
The procedure for identification of the test system
The statement of the proposed statistical methods to be used
RESPONSE: Protocol Change #2 has been approved and issued. It includes both the procedure
for identification of the rats and the proposed statistical methods to be used.

Prepared By: R. Derich Date: 3/26/00

Approved By: W. C. Jones Date: 3/27/00
Proposed Completion Date(s): 3/27/00
Study Director: J. C. Smith Date: 3/27/00

QAU REVIEW:
Action Plan Acceptance Date: March 30, 2000
By: A. V. Moulchin
Completed: 3/30/00

© 2000 by CRC Press LLC

 NORTHERN RESEARCH, INC.
QUALITY ASSURANCE

INSPECTION REPORT

D. Williams, PhD
To: ______________________________ K. Bellows, DVM
and ________________________
STUDY DIRECTOR
______________________________ MONITOR
________________________
Please respond to the observation below, and return this report to the
Quality Assurance Unit by 4/16/00.
Report Number: 00-006
__________________________
Study Number: 99-314
__________________________ Page: 1 of 1
__________________________
Test Article: BD-149
__________________________ Date: 3/6/00
__________________________

This is a CONFIDENTIAL legal document that is to be maintained by Quality Assurance for the pe-
riod of time as prescribed by the Good Laboratory Practice Regulations.

STUDY PHASE(S) INSPECTED INSPECTION DATE(S)

Initiation: 12/17, 18, 24/99; 3/2, 6/00

In-Process: ✓
Completion:
Reporting:
P. Verke P. Verke 3/6/00
OBSERVATION: SOP 43-74A, Subcutaneous Injections of Primates, requires the use of a 23-gauge
needle for administration of the test article mixture or control substances for a
2-minute duration. A 20-gauge needle was being used, and the mixtures were ad-
ministered for a duration of 1 minute.
RESPONSE: For these larger primates (4.5–5.5 kg) the increased cannula size and administra-
tion rates are appropriate. The SOP will be modified, reflecting the increases in
cannula size and administration rates correlated with primate weight averages.

Prepared By: W. Strykowski Date: 3/12/00

Approved By: K. Bellows Date: 3/14/00
Proposed Completion Date(s): 4/15/00
Study Director: D. Williams Date: 3/17/00

QAU REVIEW:
Action Plan Acceptance Date: 3/20/00
By: P. Verke
Completed: 4/16/00

© 2000 by CRC Press LLC

 NORTHERN RESEARCH, INC.
QUALITY ASSURANCE

INSPECTION REPORT

G. Robbins, PhD
To: ______________________________ L. Kannal, PhD
and ________________________
STUDY DIRECTOR
______________________________ MONITOR
________________________
Please respond to the observation below, and return this report to the
Quality Assurance Unit by 1/21/00.
Report Number: 99-112
__________________________
Study Number: 99-257
__________________________ Page: 1 of 1
__________________________
Test Article: BD-149
__________________________ Date: 12/20/99
__________________________

This is a CONFIDENTIAL legal document that is to be maintained by Quality Assurance for the pe-
riod of time as prescribed by the Good Laboratory Practice Regulations.

STUDY PHASE(S) INSPECTED INSPECTION DATE(S)

Initiation: 12/17–20/99
In-Process:
Completion: ✓
Reporting:
A. D. Moulchin A. D. Moulchin 12/23/99
OBSERVATION: During necropsy, spinal fluid was collected from each animal. No departmental
SOP existed describing this procedure.
RESPONSE: The method describing this procedure has been written and will be documented in
a new SOP.

Prepared By: J. Rodriguez Date: 12/27/99

Approved By: L. Kannal Date: 1/2/00
Proposed Completion Date(s): 1/17/00
Study Director: G. Robbins Date: 1/3/00

QAU REVIEW:
Action Plan Acceptance Date: 1/8/00
By: A. D. Moulchin
Completed: 1/21/00

© 2000 by CRC Press LLC

 NORTHERN RESEARCH, INC.
QUALITY ASSURANCE

INSPECTION REPORT

G. Robbins, PhD
To: ______________________________ L. McCarley, MS
and ________________________
STUDY DIRECTOR
______________________________ MONITOR
________________________
Please respond to the observation below, and return this report to the
Quality Assurance Unit by 4/6/00.
Report Number: 00-027
__________________________
Study Number: 99-257
__________________________ Page: 1 of 1
__________________________
Test Article: BD-149
__________________________ Date: 3/6/00
__________________________

This is a CONFIDENTIAL legal document that is to be maintained by Quality Assurance for the pe-
riod of time as prescribed by the Good Laboratory Practice Regulations.

STUDY PHASE(S) INSPECTED INSPECTION DATE(S)

Initiation: 2/28; 3/4, 6/00

In-Process:
Completion:
Reporting: ✓
A. D. Moulchin A. D. Moulchin 3/9/00
OBSERVATION: The following were observed in the appended Statistical Report:
In Table 2, Urinanalysis, the mean pH of the T2 females and T3 males are respec-
tively recorded as 6.5 and 7.3. Calculations associated with the raw data indicate re-
spective mean pH of 6.7 and 7.0.
In Table 5, Absolute and Relative Animal Organ Weights, the mean kidney weight
of the T4 males is recorded as 44.23 g. Calculations associated with the raw data in-
dicate a mean of 47.57 g.
RESPONSE: The errors noted above in Tables 2 and 5 of the Statistical Report have been cor-
rected and the database changed to reflect the raw data.
Prepared By: R. Chin, PhD (Statistician) Date: 3/12/00
Approved By: B. Murphy, PhD (Stats. Mgr.) Date: 3/17/00
Proposed Completion Date(s): 3/20/00
Study Director: G. Robbins Date: 3/18/00

QAU REVIEW:
Action Plan Acceptance Date: 3/20/00
By: A. D. Moulchin
Completed: 3/23/00

© 2000 by CRC Press LLC

 NORTHERN RESEARCH, INC.
QUALITY ASSURANCE

AUDIT REPORT

Report Number: 99-105 Page 1

Date: 11/26/99
Department Audited: Analytical Chemistry
Location: Coeur d’Alene, ID
Date(s) Audited: 11/18–21/99
Auditors: M. Simpson M. Simpson 11/26/99

OBSERVATION: 1—The Test Method validation file for determining the potency of test article
ST-211 had been approved by the department manager on 10/16/99. Animals in
study 99-125 were dosed with this compound seven days prior to approval of the
validated test method on 10/9/99.

2—SOP 796-35.02, MS-345 Determination-HPLC, approved 5/3/97, requires that

for each standardization and test, the chromatographic system components be
identified on the charts.

Examination of the applicable HPLC charts, run 11/06/99, indicate that only the
column has been identified.

RESPONSE: 1—The Test Method for the determination of potency for ST-211 includes more
than three determinations consistently using the same methodology and performed
by the same scientist. This had been reviewed in Dr. Shaw’s Laboratory Notebook,
accepted and acknowledged by management on 10/3/99. The formal Test Method-
ology Report was signed, as indicated, on 10/16/99. An explanation will be written,
filed both in the validation file and with the documentation for study 99-125.

2—These identity requirements had inadvertently been excluded; however, they

had been recorded in the scientist’s Laboratory Notebook, and have now been tran-
scribed to the proper charts. This individual and other members of the department
have been cautioned to be more meticulous.

Prepared By: R. Shaw, PhD, Methods Development Date: 11/28/99

Approved By: W. Kimura, PhD, Laboratory Manager Date: 12/4/99

QAU REVIEW:
Report Return Date: 12/5/99
Accepted By: J. A. Kensington Plan Accepted Date: 12/6/99
Title: Manager QA
Auditor: M. Simpson Plan Completed Date: 12/18/99

© 2000 by CRC Press LLC

 NORTHERN RESEARCH, INC.
QUALITY ASSURANCE

AUDIT REPORT
Contract Laboratory

Report Number: 00-030 Date: 6/18/00

Facility Audited: Southwestern Laboratories (SWL)
Location: Albuquerque, NM
Date(s) Audited: 6/11/00
Auditors: B. E. Anderson B. E. Anderson 6/18/00
AUDIT SCOPE: At the request of Drug Safety Evaluation (DSE), the QAU evaluated the
organization, facilities, operations, and SOPs of SWL with intensive sur-
veillance of their QAU.
AUDIT COVERAGE:
Facilities: There are four buildings at this site, three used for nonclinical studies. Primates
were in Bldg. B; observed building and room maintenance, cage washing, and fa-
cility security. Bldg. A contained the QAU, the archives, and computer opera-
tions. Evaluated QAU facilities and files. Observed raw data, report retention,
and histology tissue storage.
Operations: Observed technicians IM dosing, measuring body weights and food consump-
tion, recorded by clinical signs; general facility animal husbandry and computer
operations. Concurrently reviewed the QAU auditor’s documentation process.
Documentation: Reviewed the SOPs of the study function groups and the QAU. Also reviewed the
Master Schedule, CVs of personnel, pest applicator’s log, cage wash equipment
log, instrument calibrations, and primate TB treatment test records.
Recommendation: Our evaluation of SWL indicates that it has an excellent staff of scientific and
technical personnel. Their management personnel stress total compliance and
administer the most stringent international standards to all of their contracted
regulated studies. We would recommend contracting with SWL, contingent on
their acquiring a remote secondary backup tape storage facility.
Observation: SWL stores its computer backup tapes within the computer operation’s facilities
of Bldg. A. It does not have off-site location for the secure storage of secondary
backup tapes.
Response: In my phone conversation of 6/22/00 with Dr. Simmons, President of SWL, he
informed me they have a project commencing on 7/1/00, providing for second-
ary computer tape storage in a local bank vault.
Prepared By: K. Patel, DVM, Toxicologist Date: 6/23/00
Approved By: R. Schubert, PhD, Director DSE Date: 6/25/00

QAU REVIEW:
Report Return Date: 6/23/00
Accepted By: J. A. Kensington Plan Accepted Date: 6/24/00
Title: Manager QA
Auditor: B. E. Anderson Plan Completed Date: 7/6/00

© 2000 by CRC Press LLC