Information
-
Document No.
-
Audit Title
-
Client / Site
-
Conducted on
-
Prepared by
-
Location
-
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?
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?
-
If so, Describe and Provide copies.
-
Logistics:
-
Lab Ownership:
-
Does the lab use any sub contractor services?
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)
GENERAL
-
Does Organization have a Mission Statement? Describe.
-
Location(s):
-
SOP's Reviewed? Describe.
SOP's Reviewed? List each SOP
-
SOP Number
-
SOP Content
-
Were Training Records Reviewed?
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.
-
Disaster Recovery Plan Available? Describe.
-
Blood and Body Fluid Management Program? Describe.
-
Waste Disposal
-
Employee Training
-
Patient Training and Expectations
-
CPR Training? Describe.
ORGANIZATION AND PERSONNEL
-
Organizational chart exists and accurately represents the organization? Decribe.
-
Is the laboratory affiliated with other organizations? Identify the organizations:
-
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:
-
Is the CV and job description signed and dated?
-
Are there personnel curricula (training matrix/plan) established and documented for each individual? Decribe.
-
Are staff related to the conduct of the study on conformance? Describe.
-
Does the training program include new hire training and re-qualification training for personnel? Decribe.
-
Has personnel been appropirately trained to perform functions required by job descriptions? Decribe.
-
Is there a procedure to assess and document personnel competency on an annual basis? Decribe.
-
Is there an escalation process by which personnel that do not pass competency on an annual basis? Decribe.
-
Has the Laboratory manager received GCLP training? If so, by what organization and when?
-
Has personnel received regulatory training? GCLP? GCP? GLP? Other:
-
Has personnel received health/safety training? List safety training provided:
-
Is there a system in place for personnel to report any safety concerns or incidents? Decribe.
-
Does the laboratory have sufficient qualified personnel to perform function that support the GCLP clinical trial? Decribe.
-
Is there a list of consultants and is their qualifications maintained? Decribe.
-
Are external contractors/vendors utilized? If so, are they qualified/approved for use? Is there an SOP that outlines this process?
-
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?
-
Does the Quality Assurance Unit perform audits, trend metrics and report the results to the Laboratory Management? Decribe.
-
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.
INSPECTIONS AND CERTIFICATIONS
-
Does the laboratory maintain any certifications/licenses? Describe.
-
Does the lab participate in CLIA?
-
Does the lab participate in CAP?
-
Does the lab participate in Proficiency Testing?
-
Does the lab participate in Blinded Sample Analysis?
-
Was a copy of each current certification obtained?
-
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.
-
Was a copy of the inspection and certification obtained?
-
How are lab normals calculated?
-
Was a copy of the most recent normals obtained?
Most recent audits or inspections:
-
Agency:
-
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.
-
Are SOPs in compliance with the current version governing SOPs?
-
Is there a current index listing of the SOPs available? Decribe.
-
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?
-
Is there a schedule for review of the SOPs and are the SOPs current? Decribe.
-
Are the SOPs in locations where they are used and does the lab staff have access? Decribe.
-
Is there a system for documenting and handling SOP/method deviations and CAPAs? Decribe.
-
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.
FACILITY
-
Security and confidentiality is adequate to prevent unauthorized access to records/test samples and a procedure to report unauthorized access exists? Decribe.
-
Are security staff employees or contracted?
-
Are there security cameras, window and door alarms?
-
Is there sufficient space to store materials, archive records, equipment to function properly and conduct laboratory testing? Decribe.
-
Is the work flow designed to prevent contaminations and mix-ups of test samples? Decribe.
-
Are storage and processing areas separate? Describe.
-
Does the lab have a floor plan/facility design?
-
Is the facility maintained and clean?
-
Is there safety equipment (e.g. showers, eyewash stations) available? Is the equipment maintained?
-
Are updated Material Safety Data sheets and Certificate of Analysis available? If so, describe where they are stores and if the labs have access.
-
Are there environmental controls within laboratory and are the controls monitored? Decribe.
-
Are personnel wearing appropriate garmenting for designated areas? Decribe.
-
Is there an SOP detailing the designated routes and methods available for waste disposal? Decribe.
-
Is the biohazardous and hazardous chemical waste disposal described? Decribe.
-
Is there sanitation or cleaning procedure establised and is it being followed and documented? Decribe.
-
Does the Laboratory have a disaster recovery plan that covers all areas for the facility including computer systems and equipment? Describe.
-
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.
-
Does the lab have an SOP for the testing and maintenance of generators? Request to review generator logs.
-
Does the lab use a water purifying system? Are there logs to show maintenace of the system? Grade of water utilized?
EQUIPMENT
-
Is equipment used for GCLP studies readily distinguishable from equipment used for non-GCLP studies? Decribe.
-
Is there a Master Equipment Inventory present? Decribe.
-
Are there site-specific SOPs detailing equipment use, maintenance and calibration? Decribe.
-
Is the equipment utilized in the lab suitable to perform the required operations? Decribe.
-
Are user logs utilized for equipment/maintence/repair/calibration and do they include a chronological record of use? Decribe.
-
Log entries show the date, time, name of person performing and checking the work, as appropriate.
-
Equipment calibration and/or preventative maintenance schedules have been established and are being followed and documented.
-
Are equipment calibration and/or preventative maintenance schedules listed in an instrument log book?
-
Records of equipment calibration or maintenance are mainted in the laboratory and archived. Decribe.
-
Is there a system for moving or removing a piece of equipment from service or tagging the equipment? Documentation? Decribe.
-
Calibration of the equipment is traceable to NIST or another recognized standards institution. Decribe if the standards have an expiration date. Are they current?
-
Are there established tolerance limits for the equipment? Who established the tolerance ranges?
-
Are the equipment manuals available and stored near the instruments? Decribe.
-
Is there a written equipment qualification/validation program? Decribe.
LABORATORY CONTROLS
-
Are there an assay validation, re-validation and limited validation process outlined in a SOP? Decribe.
-
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.
-
What are the criteria for repeating samples?
-
Are results that fail specifications investigated or non-conformances investigated? If so, How are they investigated?
-
Are there validated methods and acceptance criteria for each test method? Decribe.
-
Is there a SOP for significant figures? Decribe.
-
Is there a SOP that outlines good documentation practices? Decribe.
REAGANT AND SOLUTION LABELING AND QUALIFICATION
-
Is there an SOP that outlines how reagents are labeled, how expiration dates are established? Decribe.
-
Are reagents qualified for use? Is parallel testing of the reagents performed? Decribe.
-
Is there a current inventory of all reagents and solutions? If so, are the reagents viewed in the labs properly labeled? Describe.
SAMPLE SHIPMENT, RECEIPT AND STORAGE
-
Is there a SOP for sample receipt, shipment and storage of materials and test samples? Decribe.
-
Are storage units monitored for temp/humidity? Validated?
-
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.
-
Is the sample receipt area maintained separate from the sample processing area? Describe.
-
Are samples stored separately from standards and reference samples?
-
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.
-
Is the computer network and computer systems maintained, if applicable? If so, How is it maintained and who maintains them?
-
Is there a computer validation master plan and/or SOPs? Describe.
-
List computer systems and software utilized. Are they validated and are the validation reports available?
-
Are computer systems validated? Who validates them?
-
Are changes to computer system errors maintained and investigated? Describe.
-
Are records of hardware maintenance and repairs maintained? Describe.
-
Are computers backed up routinely to prevent loss of data?
-
Is there a back up log for the computer systems?
-
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.
-
Is the LIMS (Laboratory Information Management System) complaint with 21 CFR part 11? Describe.
RECORDS AND REPORTS
-
A documentation control system exists and is functional. Describe.
-
Is raw laboratory data recorded in lab notebooks, electronically, or controlled data sheets? Describe.
-
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.
-
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.
-
Is there a SOP tor a system for the retention, storage, and destruction of records? Describe.
-
Is the sponsor notified prior to destruction of records?
-
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.
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.).
-
Is there control access to the archival facility? If so, Describe who has access.
-
How is the data retrieved from archive?
-
Is the environment of the facility monitored and controlled? Is there a fire supression system? Describe.
-
Is the procedure for archiving records outlined in an SOP? Describe.
-
Is the retention time for records stated in the SOP? If so, Describe how long records are retained on site.
-
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.)
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
-
GCLP Representative Signature and Date
-
Was the organization provided with a copy of AUDIT FORM at the conclusion of the Audit Visit? If so, who received a copy?
Copies of this Audit are provided to:
-
Name:
-
Title:
-
E-mail: