FACILITY INSPECTION CHECKLIST (2019)

Name of Facility
Date
Name of Inspector
Scope

FACILITIES - GENERAL

GENERAL FACILITIES Y N N/A

1 Facility is of suitable size
2 Adequate working areas
3 Facility appears clean/well maintained
4 Satisfactory facilities for toilets/etc.
5 Facilities are secure from the outside (perimeter fence for toxicology; no obvious signs of
research -describe)
6 Client confidentiality is adequately maintained
7 Are adequate to contain special hazards
8 If a floor plan present that adequately describes the facility with historical copies maintained
9 Is a Master Schedule available that contains all GLP requirements
10 Are historical copies of the MS maintained
11 Does the MS adequately describe the status of each study
12 Is the MS accurate (check a couple studies)

Findings/Recommendation:

ORGANIZATION AND PERSONNEL

Testing Facility Management Y N N/A

Organizational Chart available and delineates who is TFM; archivist and QA designated.
Org chart is dated and clearly shows reporting structure; historic copies archived
Has written procedures for SD/PI designation
Is independent from study personnel
Written procedures for replacing study director/principal investigator if necessary
Written procedures for assuring a GLP compliant QAU exists and QA inspections are carried out
Assures corrective actions are taken and are appropriate
Assures facilities are in compliance with GLP
Assures personnel are adequately trained and qualified and sufficient personnel exist
Job descriptions/CVs Training records Y N N/A
Job Descriptions
Available for each position on Org chart
Available for management
Available for archivist, QA, SD/PI
Contains minimum education and experience requirements
Are dated and historical copies maintained
Training Records
Are available for all staff
Procedure training documented
GLP training documented
Training Records are current (check a few)
Training on SOPs documented
Advanced training for SD and PIs

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 SD training adequate to understand all aspects of study (check a few)
Key personnel have adequate education, experience and training to meet job descriptions
CVs
CVs adequately summarize past experience and current job duties
CVs contain educational background
CVs contain formal meetings and training
External GLP training for management and SD
Are dated and historical copies maintained

Findings/Recommendations:

STANDARD OPERATING PROCEDURES

A testing facility shall have standard operating procedures in writing setting forth nonclinical laboratory study
methods that management is satisfied are adequate to insure the quality and integrity of the data generated in
the course of a study. All deviations in a study from standard operating procedures shall be authorized by the
study director and shall be documented in the raw data. Significant changes in established standard operating
procedures shall be properly authorized in writing by management.
GENERAL Y N N/A
Is there a document describing who can approve SOPs as management?
Methods in place for periodic review/documentation to assure SOPs are current
Methods in place for review and documentation by study personnel
SOPs immediately available to study personnel, especially if electronically distributed
SOPs have been revised/reviewed in the past year ( or two, depending on SOP for SOPs)
SOPs reflect current procedures (compare select SOPs to procedures)
Is SOP index complete and dated
Revision history available and documented
Are the following general SOPs in place Y N N/A

SOP for SOPs (writing/reviewing/revising/retiring SOPs)

Data handling, storage, and retrieval
Training of scientific staff
Maintenance of personnel files, including periodic reviews
Duties and responsibilities of facility management
Duties and responsibilities of Study Directors
Duties and responsibilities of Principal Investigators
Assignment of internal study numbers
Protocol requirements and signatures necessary for approval
Documentation and reporting of protocol amendments/deviations
Documentation and reporting of SOP deviations
Maintenance of the Master Schedule
Procedures to be followed during regulatory/sponsor inspections
Recording of data and observations
Documentation of study specific phone conversations/correspondence
Significant figures and rounding procedures
Labeling reagents and solutions
Maintenance, use, calibration of temperature monitoring devices
Source/final report requirements
Procedures for amending reports
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 Archiving requirements/procedures and archivist duties
Transfer of raw data
SOPs as per specific discipline (see attachments)

Findings/recommendations:

TEST/CONTROL ARTICLES

Receipt and Use Y N N/A

Receipt and condition upon receipt adequately documented
Adequate usage/accountability documentation
Amount and container description documented
Physical description of test material documented
Storage Y N N/A
Do separate areas exist for
Receipt of test/reference articles
Storage of test articles
Test article mixing
TA storage Y N N/A
Is access limited
Environmentally controlled
Temperature continually monitored
Adequate calibration of temperature monitoring device
Calibration methodology
Temperature range adequate for compound integrity
Storage area adequately ventilated (describe)
Storage areas neat, organized to preclude mix-up
Adequate separation from study specimens
Temperature logbook up to date

Findings/recommendations:

SPECIMEN AND SAMPLE STORAGE AREAS

Receipt and Handling Y N N/A

Separate from test material/reference standard storage area
Clean, organized free from contamination
Individual freezers or areas uniquely identified
Tracking/accountability system in place and adequate
Freezer/area inventories maintained
Adequate separation of treated and controls when applicable)
Temperatures continuously recorded
Recording devices adequately calibrated
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 Back up generators available
Alarm system in case of malfunction in place

Other backup system in place

Equipment log available on freezers/refrigerators
Temperatures recorded with acceptable ranges
Routine and non-routine maintenance documented
Malfunctions documented
SOP present and provides
Routine testing (including alarms)
Acceptable temperature ranges
Calibrartion/standardization methods and intervals
Remedial action in case of malfunction

Findings/recommendations:

GENERAL LABORATORY AREAS

General Y N N/A
Work areas neat clean unclutters
Ample bench space
Reagents and Solutions properly labeled
No outdated reagents or solutions present
Any equipment not used for regulatory studies identified (if applicable)
SOPs immediately available to laboratory personnel
Proper work attire worn (Labcoats, safety glasses)
Proper storage for all chemicals
Spill procedures posted
Safety showers present
Spill kit available
Emergency contact number posted
Fire extinguishers present
Canisters appropriately secured
Eye wash stations present
Fume Hoods calibrated
BALANCES AND SCALES Y N N/A
Are scales/balances or weights certified
Calibration/servicing as per SOP
Does certification certificate indicate tolerances and certified range
Is calibration check performed before each weighing
Weights and ranges used appropriate for scale/balance
Do SOPs require scale checks to bracket expected weight range
Logbooks present and up to date
Target weight, weight ID and observed weight recorded
Tolerances provided
Routine maintenance recorded and indicates whetehr SOP was followed
Non-routine indicates nature of defect, how/when discovered and remedial
SOPs available and contain all GLP required elelments
Routine inspection/maintenance intervals specified

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Calibration/standardization procedures specified
Remedial action to be taken in case of malfunction specified
Responsible person for performance of each operation specified

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Findings/recommendations:

EQUIPMENT/INSTRUMENTATION (OTHER THAN SCALES/BALANCES/REFRIGERATORS/FREEZERS)

EQUIPMENT Y N N/A
Equipment adequately cleaned/in good repair
Equipment suitably designed and located
Equipment adequately stored when not used
SOPs on each piece of equipment present and contains
Routine inspection/cleaning intervals specified
Routine maintenance procedures/timeframes defined
Calibration/standardization procedures specified
Remedial action to be taken in case of malfunction specified
Responsible person for performance of each operation specified
Maintenance from owners manual included or manual attached
Equipment logbooks present and up to date
Contains standardization/ calibration records
Owners manual immediately available if referenced in SOP
Routine and non-routine maintenance specified and documented
Specifies whether or not SOP was followed for routine maintenance
Specifies nature of defect, how and when discovered and remedial actions for non-routine
INSTRUMENTATION Y N N/A
Automated data collection systems validated and validation packages available
High level computerized system document available showing all interfaces
Security systems in place for instrumentation (login w/ID password)
Systems backup as per SOP
Additional system/data backup located off-site
SOP defines static vs. dynamic data with archiving requirements included for each
Part 11 compliant if applicable

Findings/Recommendations:

ARCHIVES

General Y N N/A
Are the archives adequate & with limited access
Are smoke detectors and alarms present
Is temperature and humidity monitored?
Are the archives environmentally controlled to minimize deterioration of documents
Are archives fireproof and designed to minimize deterioration
Are procedures in place and adequate for logging in and out data
Date archived
Logged out to whom and by whom
Date returned and alterations/reasons documented
Is there a designated archivist and back-up
Is the material indexed to permit expedite retrieval
Are indexing procedures in writing
Are the archives neat and orderly
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 Are all facility records archived? How often
Is there an SOP and does it adequately detail archiving procedures
Is there an SOP detailing archivist duties
Does data retention meet GLP requirements
Are provisions in place for secure storage of electronic data?
If electronic data are archived as part of the system, are procedures detailed and under the
control of the archivist
Have procedures for migration of data been established

Findings/Recommendations:

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QUALITY ASSURANCE UNIT

General Y N N/A
Is there an independent QA Unit?
Has the QAU undergone formal GLP training
Does at least one member belong to SQA or regional chapter
Does at least one member routinely attend the annual SQA meeting
Does the QAU report directly to facility management
Is the method of reporting adequate (documented in writing and timely)
Does the QAU conduct periodic facility inspections
Does the QAU inspect critical phases of each study
Are critical phases defined in an SOP
Are process based inspections used to supplement critical phase inspections for routine items
Does QA periodically review raw data for studies greater than a month
Does the SOP include what percentage of data points are audited
Does QA report findings to Study Directors promptly (within 5 days)
Are inspections reported to PIs in a timely fashion?
Is the method of reporting adequate (i.e. email requesting response)
Are findings reported to TFM in a timely manner so TFM can assure corrective actions are
appropriate
Are methods in place to confirm receipt of QA findings by SD?
Are systems in place for follow-up of QA inspections?
Do inspection procedures provide sufficient detail
Do inspections indicated recommend corrective actions and reinspections
Are all QA records kept in a central location
Does the QA statement meet GLPs and provide adequate detail
Does the QAU offer periodic GLP training to staff
Is the QAU adequately staffed
Does the QAU appear to have adequate management support
Does QA maintain a copy of all signed, approved protocols and amendments
QA SOPs Are QA SOP's adequate Y N N/A
Training of Quality Assurance personnel
Duties and responsibilities of the QAU
Reporting of QA findings, including time frames (internally and externally)
Inspecting various types of studies (checklists included)
Internal facility audits
Method of indexing QA records/records to be maintained by QA
Does the QAU maintain a copy of the Master Schedule
Does the QAU have a copy of the final regulations
Are member of the QAU recognized QA Professionals?

OTHER
If the site is involved in multi-site studies are appropriate SOPs available
Does QA and technical staff qualify all subcontractors
Are site inspections conducted of subcontractors at least every two years
Are SOPs in place to detail systems to be followed when Sponsors select subcontractors
Does the site provide sufficient oversight to subcontractors and is it detailed in SOPs

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Findings/Recommendations:

Appendix 1 – ANALYTICAL SPECIFIC

GENERAL _ SPECIMEN HANDLING Y N N/

A
Adequate specimen log-in/inventory procedures
Temperatures continually monitored through out storage
Specimen log-in study specific and not co-mingled
Specimens 100% tracked and documented throughout study
Documentation to support thaw times (when applicable)
Specimen processing adequately documented
Specimens processed with dry ice (when applicable)
Documentation of extract storage conditions
Extracts/specimens stored separate from reference standards
Documentation in place for extraction/analysis procedures
Adequate procedures in place for disposition of specimens

GENERAL – REFERENCE STANDARDS

Documentation to support receipt and storage of reference standards
Accountability records present for neat standards
Adequate tracking of neat standards and dilutions
Documentation available for standard solution preparation

ACQUISITION SYSTEMS
Software acquisition and processing systems validated
High level document available to show interfaces
Back-up procedures in place and data stored off-site
Archiving procedures documented
Export options for data in non-proprietary formats known and validated and
secure

OTHER
Does the laboratory have personnel involved in National/International
organizations to keep up on latest guidance’s and Agency requirements
(such as ISR, temperature monitoring od sample shipment, etc.)

SOPS – are the following SOPs available

Reference standard receipt/storage/accountability
Preparation/accountability of standard solutions
Stock solution dilutions/storage requirements/assignment of expiration
dates
General conduct of chromatographic assays
Acceptance and rejection of chromatographic runs/data points
Validation of analytical methods Y N N/A
Analytical terminology
Rejection of outliers
General laboratory procedures
Standardization/calibration of instrumentation
Validation of data acquisition systems
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Use and security of data acquisition systems
Receipt/storage and tracking of specimens
Storage requirements/accountability of specimen extracts
Specimen disposition

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Toxicology/TASS Specific

General Y N N/A
Does the facility have an IACUC/how often do they meet/who are the members
What role does QA play on the IACUC?
Is the facility AAALAC certified? Are any technicians AAALAS certified?
When was the last USDA inspection? Have deficiencies been corrected?
Animal care – toxicology facilities (and TAS when applicable)
Are door sweeps present?
Is critical information located on the outside of animal rooms?
Are viewing windows available?
Are rooms for reproductive studies adequately controlled (day/night).
Have light timers been verified
What type temperature monitoring system is used? Has it been validated?
How are room temperatures controlled? How often is this checked?
Does pest control appear adequate?
Is there evidence of pests
Are animals screened for diseases
Has the facility audited it’s animal vendors
Are animal procurement vendors documented
Are newly received animals quarantined from all others
Are animals vet checked prior to release for studies
Are diseased animals isolated
Are procedures in place to prevent movement of personnel and equipment from isolation
areas to study rooms? Are the air intake/exhaust systems separated
Are Animal Welfare issues addressed (exercise for dogs, psychological enrichment for
primates)
Are cage washing procedures sufficiently validated and documented
Are clean and dirty areas well defined and kept separated
Is bedding type documented for rodents?
Has bedding been checked for interfering compounds
Are automatic waterers used? If so are lines bled and flushed with each change
Do animal rooms appear clean with animals well maintained
Is a vet on site? How many? Are they knowledgeable of GLPs?
Animal feed Y N N/A
Is certified feed used for study animals
Is feed analyzed for contaminants? Are acceptance criteria available
Is feed stored on pallets or on floors
Is feed 3” from wall (AAALAC)?
Is feed rotated? Is any expired feed present
Is perishable feed adequately stored
Are mixtures stored separate from housing units?
Water Y N N/A
Is water source documented
Is water treated
Is water analyzed for contaminants
Are water samples taken from areas entering building and at farthest location
Is there acceptance criteria for water
Does appropriate personnel review water analysis and is this documented
Pest control Y N N/A
Are pest control procedures defined in SOPs
Is there complete documentation of any chemicals sprayed
Are pest control chemicals ever sprayed in animal rooms
Is management aware of all pest control
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 Could pest control procedures potentially contaminate study areas

Toxicology (con’t)

Animal cage/area cleaning Y N N/A

Are SOPs available for cleaning animal areas/rooms
Have cleaning methods been validated
Are pens/areas/cages disinfected and cleaned
Are cage washing procedures well defined
Are water temperatures verified for cage washing
Are cages tagged after being cleaned
Are clean cages kept out of dirty areas from cleaning to placement in rooms
SOPs – are the following SOPs available Y N N/A
Animal room preparation (for each species)
Animal observations (for each species)
HVAC systems
Ordering and qualifying feed
Analysis of feed for contaminants
Analysis of water for contaminants
Identification of test animals
Dosing procedures
Animals care (including vet authority and treatments)
Ordering, storage and rotation of feed
Ordering and storage of bedding
Handling moribund and dead animals on study
Sacrifice procedures
Necropsy procedures
Specimen collection, labeling and handling
Sanitation of cages and animal areas
Disposition of animal waste
Disposition of dead animals
Pest control procedures
Housing/caging requirements for test animals (each species)
Cleaning of animal rooms during studies

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