Lab Corps - GCLP Audit

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

INTERNAL INFORMATION

• Requested/Authorized by:

• Archive Record Number

• Scope of Services Proposed:

• Scope of Audit:

• Applicable Standards:

Vendor Type

• What type of vendor is being used?

  IRB

  CRO

  Phase I

  Supplier

  Other

DESCRIPTION

• Corporate Name:

• Address/Telephone/Fax:

• Website:

• Manager or Executive in Charge:

• Manager or Executive in Charge Phone and E-Mail:

• Quality Contact:

• Lab Director/Contact

• Pathologist Medical Director/Contact

• Is the Organization credentialed by any Professional Group?

  Yes

  No

  N/A

• If so, Describe and Provide copies.

• Logistics:

• Lab Ownership:

• Does the lab use any sub contractor services?

  Yes

  No

  N/A
If so, Identify.

• Organization Name

• Services

• If the lab uses sub contractors: How are they vetted? Who approves them?

• If the lab uses sub contractors: Are audit reports issued? May Sponsors view them?

• Was a copy of the Lab License obtained? (State, Local, and/or National)

  Yes

  No

  N/A

GENERAL

• Does Organization have a Mission Statement? Describe.

  Yes

  No

  N/A

• Number of Employees

• Location(s):

• SOP's Reviewed? Describe.

  Yes

  No

  N/A
SOP's Reviewed? List each SOP

• SOP Number

• SOP Content

• Were Training Records Reviewed?

  Yes

  No

  N/A
Describe records for each appropriate personnel. (ie. Project Managers, QA, Lab Scientist, etc.)

• Name of Personnel

• Title of Personnel

• Training Record

• Emergency Management Plan? Describe.

  Yes

  No

  N/A

• Disaster Recovery Plan Available? Describe.

  Yes

  No

  N/A

• Blood and Body Fluid Management Program? Describe.

  Yes

  No

  N/A

• Waste Disposal

• Employee Training

• Patient Training and Expectations

• CPR Training? Describe.

  Yes

  No

  N/A

ORGANIZATION AND PERSONNEL

• Organizational chart exists and accurately represents the organization? Decribe.

  Yes

  No

  N/A

• Is the laboratory affiliated with other organizations? Identify the organizations:

  Yes

  No

  N/A

• What are the organziations responsibilities in relation to our study? How are they vetted?

• Are training records available? List the components of the training record:

  Yes

  No

  N/A

• Is the CV and job description signed and dated?

  Yes

  No

  N/A

• Are there personnel curricula (training matrix/plan) established and documented for each individual? Decribe.

  Yes

  No

  N/A

• Are staff related to the conduct of the study on conformance? Describe.

  Yes

  No

  N/A

• Does the training program include new hire training and re-qualification training for personnel? Decribe.

  Yes

  No

  N/A

• Has personnel been appropirately trained to perform functions required by job descriptions? Decribe.

  Yes

  No

  N/A

• Is there a procedure to assess and document personnel competency on an annual basis? Decribe.

  Yes

  No

  N/A

• Is there an escalation process by which personnel that do not pass competency on an annual basis? Decribe.

  Yes

  No

  N/A

• Has the Laboratory manager received GCLP training? If so, by what organization and when?

  Yes

  No

  N/A

• Has personnel received regulatory training? GCLP? GCP? GLP? Other:

  Yes

  No

  N/A

• Has personnel received health/safety training? List safety training provided:

  Yes

  No

  N/A

• Is there a system in place for personnel to report any safety concerns or incidents? Decribe.

  Yes

  No

  N/A

• Does the laboratory have sufficient qualified personnel to perform function that support the GCLP clinical trial? Decribe.

  Yes

  No

  N/A

• Is there a list of consultants and is their qualifications maintained? Decribe.

  Yes

  No

  N/A

• Are external contractors/vendors utilized? If so, are they qualified/approved for use? Is there an SOP that outlines this process?

  Yes

  No

  N/A

• Is there a Quality Assurance Unit? If so, what are the roles of the Quality Control and the Quality Assurance group and who do they report to?

  Yes

  No

  N/A

• Does the Quality Assurance Unit perform audits, trend metrics and report the results to the Laboratory Management? Decribe.

  Yes

  No

  N/A

• What does the QA stuff review? Are they properly trained for the areas they audit?

• Is the Quality Assurance Unit independent from the personnel engaged in the direction or conduct of a clinical trial? Decribe.

  Yes

  No

  N/A

INSPECTIONS AND CERTIFICATIONS

• Does the laboratory maintain any certifications/licenses? Describe.

  Yes

  No

  N/A

• Does the lab participate in CLIA?

  Yes

  No

  N/A

• Does the lab participate in CAP?

  Yes

  No

  N/A

• Does the lab participate in Proficiency Testing?

  Yes

  No

  N/A

• Does the lab participate in Blinded Sample Analysis?

  Yes

  No

  N/A

• Was a copy of each current certification obtained?

  Yes

  No

  N/A

• Does the lab undergo an FDA/state/regional/483 inspection and certification? If so, please indicate what for and the date of the last inspection.

  Yes

  No

  N/A

• Was a copy of the inspection and certification obtained?

  Yes

  No

  N/A

• How are lab normals calculated?

• Was a copy of the most recent normals obtained?

  Yes

  No

  N/A
Most recent audits or inspections:

• Agency:

• Date:

  Date

• Findings:

STANDARD OPERATING PROCEDURES/METHODS

• Is there a governing SOP that outlines the creation, revision, approval, distribution, document control and retirement of SOPs? Decribe.

  Yes

  No

  N/A

• Are SOPs in compliance with the current version governing SOPs?

  Yes

  No

  N/A

• Is there a current index listing of the SOPs available? Decribe.

  Yes

  No

  N/A

• Are there appropriate SOPs in place to conduct the study? If labs utilize guidances in place of SOPs; where are they stored, how are they updated, and who is responsible for them?

  Yes

  No

  N/A

• Is there a schedule for review of the SOPs and are the SOPs current? Decribe.

  Yes

  No

  N/A

• Are the SOPs in locations where they are used and does the lab staff have access? Decribe.

  Yes

  No

  N/A

• Is there a system for documenting and handling SOP/method deviations and CAPAs? Decribe.

  Yes

  No

  N/A

• Who reviews and approves the documenting and handling SOP/method deviations and CAPAs? How is the Sponsor notified?

• Is there a change control system for SOP/Methods? Decribe.

  Yes

  No

  N/A

FACILITY

• Security and confidentiality is adequate to prevent unauthorized access to records/test samples and a procedure to report unauthorized access exists? Decribe.

  Yes

  No

  N/A

• Are security staff employees or contracted?

• Are there security cameras, window and door alarms?

  Yes

  No

  N/A

• Is there sufficient space to store materials, archive records, equipment to function properly and conduct laboratory testing? Decribe.

  Yes

  No

  N/A

• Is the work flow designed to prevent contaminations and mix-ups of test samples? Decribe.

  Yes

  No

  N/A

• Are storage and processing areas separate? Describe.

  Yes

  No

  N/A

• Does the lab have a floor plan/facility design?

  Yes

  No

  N/A

• Is the facility maintained and clean?

  Yes

  No

  N/A

• Is there safety equipment (e.g. showers, eyewash stations) available? Is the equipment maintained?

  Yes

  No

  N/A

• Are updated Material Safety Data sheets and Certificate of Analysis available? If so, describe where they are stores and if the labs have access.

  Yes

  No

  N/A

• Are there environmental controls within laboratory and are the controls monitored? Decribe.

  Yes

  No

  N/A

• Are personnel wearing appropriate garmenting for designated areas? Decribe.

  Yes

  No

  N/A

• Is there an SOP detailing the designated routes and methods available for waste disposal? Decribe.

  Yes

  No

  N/A

• Is the biohazardous and hazardous chemical waste disposal described? Decribe.

  Yes

  No

  N/A

• Is there sanitation or cleaning procedure establised and is it being followed and documented? Decribe.

  Yes

  No

  N/A

• Does the Laboratory have a disaster recovery plan that covers all areas for the facility including computer systems and equipment? Describe.

  Yes

  No

  N/A

• If the Laboratory has a disaster recovery plan, how are changes documented? When is a sponsor notified when the disastor plan is initiated?

• Are generators utilized at the facility? Decribe.

  Yes

  No

  N/A

• Does the lab have an SOP for the testing and maintenance of generators? Request to review generator logs.

  Yes

  No

  N/A

• Does the lab use a water purifying system? Are there logs to show maintenace of the system? Grade of water utilized?

  Yes

  No

  N/A

EQUIPMENT

• Is equipment used for GCLP studies readily distinguishable from equipment used for non-GCLP studies? Decribe.

  Yes

  No

  N/A

• Is there a Master Equipment Inventory present? Decribe.

  Yes

  No

  N/A

• Are there site-specific SOPs detailing equipment use, maintenance and calibration? Decribe.

  Yes

  No

  N/A

• Is the equipment utilized in the lab suitable to perform the required operations? Decribe.

  Yes

  No

  N/A

• Are user logs utilized for equipment/maintence/repair/calibration and do they include a chronological record of use? Decribe.

  Yes

  No

  N/A

• Log entries show the date, time, name of person performing and checking the work, as appropriate.

  Yes

  No

  N/A

• Equipment calibration and/or preventative maintenance schedules have been established and are being followed and documented.

  Yes

  No

  N/A

• Are equipment calibration and/or preventative maintenance schedules listed in an instrument log book?

  Yes

  No

  N/A

• Records of equipment calibration or maintenance are mainted in the laboratory and archived. Decribe.

  Yes

  No

  N/A

• Is there a system for moving or removing a piece of equipment from service or tagging the equipment? Documentation? Decribe.

  Yes

  No

  N/A

• Calibration of the equipment is traceable to NIST or another recognized standards institution. Decribe if the standards have an expiration date. Are they current?

  Yes

  No

  N/A

• Are there established tolerance limits for the equipment? Who established the tolerance ranges?

  Yes

  No

  N/A

• Are the equipment manuals available and stored near the instruments? Decribe.

  Yes

  No

  N/A

• Is there a written equipment qualification/validation program? Decribe.

  Yes

  No

  N/A

LABORATORY CONTROLS

• Are there an assay validation, re-validation and limited validation process outlined in a SOP? Decribe.

  Yes

  No

  N/A

• What are the criteria for a re-validation?

• Is there a written procedure for repeating testing or invalidating lab data? Is there a repeat decision tree? Decribe.

  Yes

  No

  N/A

• What are the criteria for repeating samples?

• Are results that fail specifications investigated or non-conformances investigated? If so, How are they investigated?

  Yes

  No

  N/A

• Are there validated methods and acceptance criteria for each test method? Decribe.

  Yes

  No

  N/A

• Is there a SOP for significant figures? Decribe.

  Yes

  No

  N/A

• Is there a SOP that outlines good documentation practices? Decribe.

  Yes

  No

  N/A

REAGANT AND SOLUTION LABELING AND QUALIFICATION

• Is there an SOP that outlines how reagents are labeled, how expiration dates are established? Decribe.

  Yes

  No

  N/A

• Are reagents qualified for use? Is parallel testing of the reagents performed? Decribe.

  Yes

  No

  N/A

• Is there a current inventory of all reagents and solutions? If so, are the reagents viewed in the labs properly labeled? Describe.

  Yes

  No

  N/A

SAMPLE SHIPMENT, RECEIPT AND STORAGE

• Is there a SOP for sample receipt, shipment and storage of materials and test samples? Decribe.

  Yes

  No

  N/A

• Are storage units monitored for temp/humidity? Validated?

  Yes

  No

  N/A

• What is the plan when a unit breaks down and how it is documented?

• Does the SOP contain a chain of custody procedure? If so, Decribe who retrieves samples from storage and how the removal of samples is tracked.

  Yes

  No

  N/A

• Is the sample receipt area maintained separate from the sample processing area? Describe.

  Yes

  No

  N/A

• Are samples stored separately from standards and reference samples?

  Yes

  No

  N/A

• How are the samples stored? (ie. Box, Bag Rack, etc.)

DATA HANDLING PROCEDURES AND COMPUTER VALIDATION

• Is access to computers limited by an individual username and password system (lab members cannot share a user name)? Describe.

  Yes

  No

  N/A

• Is the computer network and computer systems maintained, if applicable? If so, How is it maintained and who maintains them?

  Yes

  No

  N/A

• Is there a computer validation master plan and/or SOPs? Describe.

  Yes

  No

  N/A

• List computer systems and software utilized. Are they validated and are the validation reports available?

• Are computer systems validated? Who validates them?

  Yes

  No

  N/A

• Are changes to computer system errors maintained and investigated? Describe.

  Yes

  No

  N/A

• Are records of hardware maintenance and repairs maintained? Describe.

  Yes

  No

  N/A

• Are computers backed up routinely to prevent loss of data?

  Yes

  No

  N/A

• Is there a back up log for the computer systems?

  Yes

  No

  N/A

• How often are computers backed up? Where is the backup stored?

• Are the systems procted? How is the data retrieved?

• Is there a preventative maintenance program for computer systems? Describe program and if it is through an internal source or an external vendor.

  Yes

  No

  N/A

• Is the LIMS (Laboratory Information Management System) complaint with 21 CFR part 11? Describe.

  Yes

  No

  N/A

RECORDS AND REPORTS

• A documentation control system exists and is functional. Describe.

  Yes

  No

  N/A

• Is raw laboratory data recorded in lab notebooks, electronically, or controlled data sheets? Describe.

  Yes

  No

  N/A

• If raw laboratory data is recorded manually, how is the data verified? Who reviews the data?

• Are laboratory final reports generated for clinical studies? Who reviews the reports? Describe.

  Yes

  No

  N/A

• Who prepares and reviews the final reports?

• Does the sponsor get to review before finalizing?

• How are protocol deviations reported?

• When is the sponsor notified?

• Who makes the final determination of effect?

• Is the a SOP that outlines the content of the final report? Describe.

  Yes

  No

  N/A

• Is there a SOP tor a system for the retention, storage, and destruction of records? Describe.

  Yes

  No

  N/A

• Is the sponsor notified prior to destruction of records?

  Yes

  No

  N/A

• Does the site ensure the sponsor's proprietary information is not disclosed to unauthorized personnel or external organizations? If so, Describe how they ensure it.

  Yes

  No

  N/A

RECORD RETENTION AND ARCHIVAL

• Is there a dedicated facility/area for the archival of records? Describe what is archived (ie. Study notebooks, instrument logs, environmental records, etc.).

  Yes

  No

  N/A

• Is there control access to the archival facility? If so, Describe who has access.

  Yes

  No

  N/A

• How is the data retrieved from archive?

• Is the environment of the facility monitored and controlled? Is there a fire supression system? Describe.

  Yes

  No

  N/A

• Is the procedure for archiving records outlined in an SOP? Describe.

  Yes

  No

  N/A

• Is the retention time for records stated in the SOP? If so, Describe how long records are retained on site.

  Yes

  No

  N/A

• If records are sent off site, where is the off site storeage? How is the data retrieved?

• Is there a method of electronic data archive? If so, Describe the format (ie. Cd, DVD, tape, etc.)

  Yes

  No

  N/A

FINDINGS

• List all Deficiencies indentified including classification.

• If CAPA is required for this organization, list the CAPA requirements.

• Was a close-out conference held? If so, who was present?

• Overall Audit Assessment:

• Auditor's Recommendation:

• Auditor Signature and Date

  Sign

• GCLP Representative Signature and Date

  Sign

• Was the organization provided with a copy of AUDIT FORM at the conclusion of the Audit Visit? If so, who received a copy?

  Yes

  No

  N/A
Copies of this Audit are provided to:

• Name:

• Title:

• E-mail: