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SECTION III DOCUMENT/REPORT EXAMPLES

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Section III-1

QUALITY ASSURANCE DOCUMENTS

2000 by CRC Press LLC

2000 by CRC Press LLC

NORTHERN RESEARCH, INC. QUALITY ASSURANCE


PROJECTIONS: QAU Inspections Protocol Issued Final Report Interim Report I P R r 2000 Test Article AC-123 AC-123 BD-149 BD-149 RS-160 RS-160 Study Identity Test System Study Initiation 01/07/00 03/09/00 09/19/99 12/17/99 03/25/00 04/09/00 08/20/99 08/06/98 09/20/98 10/02/99 Study Director Smith Robbins Robbins Williams Smith Smith Gentry Robbins Williams Harris Anderson Nature of Study and Current Status/Final Report Acute PO Tox/In-Preparation One-Month IV Tox/In-Process Three-Month IV Tox/ Issued 3/26/00 Six-Month IV Tox/In-Process Acute IV Tox/Protocol One-Month IV/Protocol Ames Test/In-Preparation Twelve-Month Diet/In-Process 2-Year Carcinogenicity Diet In-Process 2-Year Carcinogenicity Diet In-Process Three-Month PO Tox/In-Preparation r I r R I M A M R I R I P I P R I I I I I I R I R I I R J J A S

Page 1 Status: March 27, 2000

MASTER SCHEDULE

2001 O N D J F

99-322 Mouse 00-107 Rat 99-257 Dog 99-314 Monkey 00-059 Rat 00-103 Rat

TM-172 99-337 Salmonella 03/05/00 VW-178 99-157 Dog ST-205 ST-205 WS-310 98-145 Mouse 98-147 Rat 99-258 Dog

R I I I

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STUDY INSPECTION RECORD

Version 1

Study Title: Test Article: Study Identity: Study Species: Route: Study Director: Study Phase Initiation Inspection Dates 9/19, 20/99 9/24,25/99

Three-Month Intravenous Toxicity BD-149 99-257 Dog IV G. Robbins, Ph.D. Signature/ Date A.D. Moulchin 9/20/99 A.D. Moulchin 9/25/99 A.D. Moulchin 10/17/99 A.D. Moulchin 10/25/99 A.D. Moulchin 11/15/99 A.D. Moulchin 12/20/99 A.D. Moulchin 1/14/00 A.D. Moulchin 2/5/00 A.D. Moulchin 2/28/00 A.D. Moulchin 3/6/00 00-027 3/6/00 3/20/00 99-112 12/20/99 1/8/00 99-093 10/25/99 11/6/99 Inspection Report No./Date Corrective Action Acceptance Date

In-Process

10/8, 1517/99 10/2325/99 11/1215/99

Completion

12/1720/99 1/13,14/00 2/5/00

Reporting

2/28/00 3/46/00

2000 by CRC Press LLC

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STUDY INSPECTION RECORD

Version 2

Study Title: Test Article: Study Identity: Study Species: Route: Study Director: Study Phase Initiation Procedure PRO AWS FOR In-Process AWS DOS FOR BCN OBS DOS Completion NEC CCH/HEM MJC Reporting RPJ

Three-Month PO Toxicity WS-310 99-258 Dog PO J. B. E. Anderson, Ph.D. Inspection Dates 10/2/99 10/2/99 10/9/99 10/7/99 10/9/99 11/12/99 12/2/99 12/6/99 12/10/99 1/2, 3/00 1/2,7/00 2/19/00 4/7-9/00 4/16/00 Signature/ Date P. Verke 10/2/99 P. Verke 10/2/99 P. Verke 10/9/99 P. Verke 10/7/99 P. Verke 10/9/99 P. Verke 11/12/99 P. Verke 12/2/99 P. Verke 12/6/99 P. Verke 12/10/99 P. Verke 1/3/00 P. Verke 1/7/00 P. Verke 2/19/00 P. Verke 4/9/00 P. Verke 4/16/00 Inspection Report No./Date Corrective Action Acceptance Date

99-097 10/9/99

10/17/99

00-002 1/7/00

1/23/00

00-017 4/16/00

4/27/00

2000 by CRC Press LLC

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INSPECTION REPORT
W. Harris, PhD To: ______________________________ STUDY DIRECTOR ______________________________ K. Bellows, DVM and ________________________ 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 __________________________ Test Article: ST-205 __________________________ Page: 1 of 1 __________________________ Date: 8/6/99 __________________________

This is a CONFIDENTIAL legal document that is to be maintained by Quality Assurance for the period of time as prescribed by the Good Laboratory Practice Regulations. STUDY PHASE(S) INSPECTED Initiation: In-Process: Completion: Reporting: B. W. Herrick B. W. Herrick 8/6/99 5/24; 6/12, 20; 7/8; 8/2/99 INSPECTION DATE(S)

OBSERVATION: The scale used in measuring body weights had an expired calibration date. Weighings 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. H. James K. Bellows 8/14/99 W. Harris Date: Date: Date: 8/8/99 8/9/99 8/12/99

Prepared By: Approved By: Proposed Completion Date(s): Study Director: QAU REVIEW: Action Plan Acceptance Date: By: Completed:

August 13, 1999 B. W. Herrick 8/19/99

2000 by CRC Press LLC

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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, 1517, 2325, 1999 November 1215, 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 signators knowledge there were no significant deviations from the Good Laboratory Practice Regulations that affected the quality of integrity of the study. James A. Kensington ______________________________ James A. Kensington Manager, Quality Assurance 3/6/00 __________________________ Date

2000 by CRC Press LLC

Section III-2

INSPECTION REPORT EXAMPLES

2000 by CRC Press LLC

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INSPECTION REPORT
J. C. Smith, PhD To: ______________________________ STUDY DIRECTOR ______________________________ W. C. Jones, DVM, PhD and ________________________ 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 __________________________ Test Article: RS-160 __________________________

Page: 1 of 1 __________________________ Date: 3/26/00 __________________________

This is a CONFIDENTIAL legal document that is to be maintained by Quality Assurance for the period of time as prescribed by the Good Laboratory Practice Regulations. STUDY PHASE(S) INSPECTED Initiation: In-Process: Completion: Reporting: A. V. Moulchin A. V. Moulchin 3/26/00 INSPECTION DATE(S) 3/25/00

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. R. Derich W. C. Jones 3/27/00 J. C. Smith Date: Date: Date: 3/26/00 3/27/00 3/27/00

Prepared By: Approved By: Proposed Completion Date(s): Study Director: QAU REVIEW: Action Plan Acceptance Date: By: Completed:

March 30, 2000 A. V. Moulchin 3/30/00

2000 by CRC Press LLC

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INSPECTION REPORT
D. Williams, PhD To: ______________________________ STUDY DIRECTOR ______________________________ K. Bellows, DVM and ________________________ 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 __________________________ Test Article: BD-149 __________________________ Page: 1 of 1 __________________________ Date: 3/6/00 __________________________

This is a CONFIDENTIAL legal document that is to be maintained by Quality Assurance for the period of time as prescribed by the Good Laboratory Practice Regulations. STUDY PHASE(S) INSPECTED Initiation: In-Process: Completion: Reporting: P. Verke P. Verke 3/6/00 INSPECTION DATE(S) 12/17, 18, 24/99; 3/2, 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 administered for a duration of 1 minute. RESPONSE: For these larger primates (4.55.5 kg) the increased cannula size and administration rates are appropriate. The SOP will be modified, reflecting the increases in cannula size and administration rates correlated with primate weight averages. W. Strykowski K. Bellows 4/15/00 D. Williams Date: Date: Date: 3/12/00 3/14/00 3/17/00

Prepared By: Approved By: Proposed Completion Date(s): Study Director: QAU REVIEW: Action Plan Acceptance Date: By: Completed:

3/20/00 P. Verke 4/16/00

2000 by CRC Press LLC

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INSPECTION REPORT
G. Robbins, PhD To: ______________________________ STUDY DIRECTOR ______________________________ L. Kannal, PhD and ________________________ 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 __________________________ Test Article: BD-149 __________________________ Page: 1 of 1 __________________________ Date: 12/20/99 __________________________

This is a CONFIDENTIAL legal document that is to be maintained by Quality Assurance for the period of time as prescribed by the Good Laboratory Practice Regulations. STUDY PHASE(S) INSPECTED Initiation: In-Process: Completion: Reporting: A. D. Moulchin A. D. Moulchin 12/23/99 12/1720/99 INSPECTION DATE(S)

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. J. Rodriguez L. Kannal 1/17/00 G. Robbins Date: Date: Date: 12/27/99 1/2/00 1/3/00

Prepared By: Approved By: Proposed Completion Date(s): Study Director: QAU REVIEW: Action Plan Acceptance Date: By: Completed:

1/8/00 A. D. Moulchin 1/21/00

2000 by CRC Press LLC

NORTHERN RESEARCH, INC. QUALITY ASSURANCE


INSPECTION REPORT
G. Robbins, PhD To: ______________________________ STUDY DIRECTOR ______________________________ L. McCarley, MS and ________________________ 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 __________________________ Test Article: BD-149 __________________________ Page: 1 of 1 __________________________ Date: 3/6/00 __________________________

This is a CONFIDENTIAL legal document that is to be maintained by Quality Assurance for the period of time as prescribed by the Good Laboratory Practice Regulations. STUDY PHASE(S) INSPECTED Initiation: In-Process: Completion: Reporting: A. D. Moulchin A. D. Moulchin 3/9/00 INSPECTION DATE(S) 2/28; 3/4, 6/00

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 respectively recorded as 6.5 and 7.3. Calculations associated with the raw data indicate respective 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 indicate a mean of 47.57 g. RESPONSE: The errors noted above in Tables 2 and 5 of the Statistical Report have been corrected and the database changed to reflect the raw data. R. Chin, PhD (Statistician) B. Murphy, PhD (Stats. Mgr.) 3/20/00 G. Robbins Date: Date: Date: 3/12/00 3/17/00 3/18/00

Prepared By: Approved By: Proposed Completion Date(s): Study Director: QAU REVIEW: Action Plan Acceptance Date: By: Completed:

3/20/00 A. D. Moulchin 3/23/00

2000 by CRC Press LLC

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AUDIT REPORT
Report Number: Date: Department Audited: Location: Date(s) Audited: Auditors: 99-105 11/26/99 Analytical Chemistry Coeur dAlene, ID 11/1821/99 M. Simpson M. Simpson 11/26/99 Page 1

OBSERVATION: 1The 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. 2SOP 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: 1The 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. Shaws Laboratory Notebook, accepted and acknowledged by management on 10/3/99. The formal Test Methodology 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. 2These identity requirements had inadvertently been excluded; however, they had been recorded in the scientists Laboratory Notebook, and have now been transcribed to the proper charts. This individual and other members of the department have been cautioned to be more meticulous. Prepared By: Approved By: R. Shaw, PhD, Methods Development W. Kimura, PhD, Laboratory Manager Date: Date: 11/28/99 12/4/99

QAU REVIEW: Report Return Date: Accepted By: Title: Auditor:

12/5/99 J. A. Kensington Manager QA M. Simpson

Plan Accepted Date: Plan Completed Date:

12/6/99 12/18/99

2000 by CRC Press LLC

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AUDIT REPORT Contract Laboratory
Report Number: Facility Audited: Location: Date(s) Audited: Auditors: AUDIT SCOPE: 00-030 Southwestern Laboratories (SWL) Albuquerque, NM 6/11/00 B. E. Anderson B. E. Anderson 6/18/00 At the request of Drug Safety Evaluation (DSE), the QAU evaluated the organization, facilities, operations, and SOPs of SWL with intensive surveillance of their QAU. Date: 6/18/00

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 facility security. Bldg. A contained the QAU, the archives, and computer operations. Evaluated QAU facilities and files. Observed raw data, report retention, and histology tissue storage. Operations: Observed technicians IM dosing, measuring body weights and food consumption, recorded by clinical signs; general facility animal husbandry and computer operations. Concurrently reviewed the QAU auditors documentation process. Documentation: Reviewed the SOPs of the study function groups and the QAU. Also reviewed the Master Schedule, CVs of personnel, pest applicators 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 operations 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 secondary 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: Accepted By: Title: Auditor:

6/23/00 J. A. Kensington Manager QA B. E. Anderson

Plan Accepted Date: Plan Completed Date:

6/24/00 7/6/00

2000 by CRC Press LLC