Test Facility Inspection Checklist

Test Facility Inspection Checklist

Internal Audit/Inspection Number: ______

1. Quality Assurance Program / Compliant / Comments / Initials/

Date

(dd/mm/yy)
Yes / No
QAU program in accordance with GLP Principles
QAU Manager designated by, and reports directly to management

QAU personnel independent of GLP study

SOPs for QAU procedures and responsibilities

QAU files/records in secure location

File with copies of GLFC GLP Documents

Copy of current GLFC GLP Organization Chart

File of current GLP Work Areas; including floor plans and maps with study identification

GLP Training Log

Log of Notification of Non-compliance to a SOP
SOP Concurrence Log
SOP Checklist for Format and Content
Peer Review Log for SOPs, Study Plans and Final Reports
QAU Master List of SOPs and Reporting Forms
Current List of SOPs
Current List of Reporting Forms
SOP Manual
File of CFS Study Work Plans for current year
Study Plan Concurrence Log
Study Plan Checklist for Format and Content
Final Report Concurrence Log
Final Report Checklist for Format and Content
QAU file for each GLP study
Master Schedule Reporting Form Log
Master Schedule
File of Internal QAU Inspections/Audits
Internal audit/inspection results reported to management, SD, PI and others, as appropriate
File of Regulatory Inspections/Audits
File of Sponsor Inspections/Audits

Test Facility Inspection Checklist

Internal Audit/Inspection Number: ______

2. Archive / Compliant / Comments / Initials/

Date

(dd/mm/yy)
Yes / No

SOPs for Archivist responsibilities and procedures

Security and access controlled by Archivist

Archive Access Log

Sufficient space and appropriate storage facilities for the materials archived
Protection from untimely deterioration (e.g., water, humidity, fire, rodents, etc)
Materials indexed for orderly storage and retrieval

Log of Materials Received

Storage Requirements for Archived Materials

Retrieval of Archived Materials

Disposal of Archived Materials, justified and documented

Logbooks for Archive refrigeration equipment (current year)
Equipment maintenance, use and calibration logs for Archive refrigeration equipment (historical records)
Hazardous Waste Log, for Archive materials
Hazardous Waste Logs, filed by name of SD

Master Schedules

Files of GLP Work Areas, including floor plans/maps indicating GLP work areas, Archive, DCO records, QA records; filed by study number

Organization Charts, current and historical

Designation of GLP Officials, current and historical

Policy Documents, current and historical

Certificates of GLP Recognition, current and historical

SOPs, current and historical

Staff Records and GLP Training files for all study personnel and GLP officials
Study Manuals; including all required elements; filed by study number.
Supporting study materials, including samples, specimens, test/reference items, etc; filed/stored by study number
Equipment Maintenance, Use and Calibration Logs for GLP studies; including manuals when retired/disposed; filed by name of SD and by equipment identifier
Test Materials and Reference Items Logbooks, filed by name of SD

Computer Validation Documentation (when not part of Study Manual), filed by name of SD and by equipment identifier

QAU Files for Internal Inspections/Audits

QAU Files for Regulatory Inspections/Audits

QAU Files for Sponsor Inspections/Audits

Duplicate Samples, taken by regulatory inspectors; identified by study number and reference to inspection

Lists of SOPs and Reporting Forms, current and historical

Study Work Plans

Log of Notification of Non-compliance to a SOP

DCO Records, including exact copies of all forms up to start of current year

Test Facility Inspection Checklist

Internal Audit/Inspection Number: ______

3. Document Control / Compliant /

Comments

/ Initials/

Date

(dd/mm/yy)
Yes / No

SOPs for DCO responsibilities and procedures

DCO files/records in secure location

DCO Study Number Assignment Log

DCO Log of SOPs

DCO Log of Reporting Forms
DCO SOP Manual

DCO Distribution Log

Test Facility Inspection Checklist

Internal Audit/Inspection Number: ______

Note: Use a page form for each GLP Work Area (i.e., suite of labs under the control of one Study Director or Principle Investigator)

4. GLP Work Areas
(identify area: ______) / Compliant / Comments / Initials/

Date

(dd/mm/yy)
Yes / No
Valid/current SOPs readily available and followed
Work areas of suitable design, size, location, separation, construction and cleanliness
Separate wet chemistry and instrument labs
Chemicals, reagents, solutions labeled and stored properly
Equipment in good working condition
Equipment Maintenance, Use and Calibration Logs
Test Material Receipt Log
Test Material Use and Distribution Log
Reference Item Receipt Log
Reference Item Use and Distribution Log
Adequate collection, storage and disposal of solvents and waste
Hazardous Waste Log

Sample Shipment and Storage Log

Sample Tracking Form (included in equipment logbook)

GLFC Radioisotope Inventory Record

Radioactive Contamination Monitoring Log

Safety Binder

GLP Form Number 0064/002 Page 1 of 5