• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Organization & Personnel

Comparison of FDA, EPA, OECD GLP Organization & Personnel
Topic FDA EPA OECD
Training &
Experience of
Personnel
58.29
(a) Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions.
792.29
(a) Each individual engaged in the conduct of or responsible for the supervision of a study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions.
Section II
1.4.1
All personnel involved in the conduct of the study must be knowledgeable in those parts of the Principles of Good Laboratory Practice which are applicable to their involvement in the study.
Summary of
Training & Job
Descriptions
58.29
(b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study.
792.29
(b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a study.
Section II
1.1.2
(c) ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual;
Personnel Access
to &
Responsibility to
Follow SOPs
    Section II
1.4.2
Study personnel will have access to the study plan and appropriate Standard Operating Procedures applicable to their involvement in the study. It is their responsibility to comply with the instructions given in these documents.
Any deviation from these instructions should be documented and communicated directly to the Study Director, and/or if appropriate, the Principal Investigator(s).
Personnel
Responsibility to
Record Data
    Section II
1.4.3
All study personnel are responsible for recording raw data promptly and accurately and in compliance with these Principles of Good Laboratory Practice, and are responsible for the quality of their data.
Sufficient
Personnel
58.29
(c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol.
792.29
(c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol.
Section II
1.1.2
(b) ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study;
Personnel Health
Precautions
58.29
(d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test and control articles and test systems.
792.29
(d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test, control, and reference substances and test systems.
Section II.
1.4.4
Study personnel should exercise health precautions to minimise risk to themselves and to ensure the integrity of the study.
Clothing for
Personnel
58.29
(e) Personnel engaged in a nonclinical laboratory study shall wear clothing appropriate for the duties they perform. Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test and control articles.
792.29
(e) Personnel engaged in a study shall wear clothing appropriate for the duties they perform. Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test, control, and reference substances.
 
Personnel Illness
Precautions
58.29
(f) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the nonclinical laboratory study shall be excluded from direct contact with test systems, test and control articles and any other operation or function that may adversely affect the study until the condition is corrected. All personnel shall be instructed to report to their immediate supervisors any health or medical conditions that may reasonably be considered to have an adverse effect on a nonclinical laboratory study.
792.29
(f) Any individual found at any time to have an illness
that may adversely affect the quality and integrity of the study shall be excluded from direct contact with test systems, test, control, and reference substances and any other operation or function that may adversely affect the study until the condition is corrected. All personnel shall be instructed to report to their immediate supervisors any health or medical conditions that may reasonably be considered to have an adverse effect on a study.
Section II
1.4.4
They should communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study.
Statement
Identifying
Testing Facility
Management
(TFM)
   

Section II
1.1.2

(a) ensure that a statement exists which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by these Principles of Good Laboratory Practice;

TFM - Assure
Compliance with
GLPs
    Section II
1.1.1
Each test facility management should ensure that these Principles of Good Laboratory Practice are complied with, in its test facility.
TFM - Designate
a Study Director
58.31
(a) Designate a study director as described in Sec. 58.33, before the study is initiated.
792.31
(a) Designate a study director as described in Sec. 792.33 before the study is initiated.
Section II
1.1.2
(g) ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the Study Director before the study is initiated.
TFM - Replace a
Study Director
58.29
(b) Replace the study director promptly if it becomes necessary to do so during the conduct of a study.
792.31
(b) Replace the study director promptly if it becomes necessary to do so during the conduct of a study.
Section II
1.1.2
(g) Replacement of a Study Director should be done according to established procedures, and should be documented.
TFM - Assure
Study Director
Approves
Protoco
   

Section II
1.1.2

(i) ensure documented approval of the study plan by the Study Director;

TFM - Assure
Study Director
Provides Protocol
to QAU
    Section II
1.1.2
(j) ensure that the Study Director has made the approved study plan available to the Quality Assurance personnel;
TFM - Establish a
QAU
58.31
(c) Assure that there is a quality assurance unit as described in Sec. 58.35.
792.31
(c) Assure that there is a quality assurance unit as described in Sec. 792.35.
Section II
1.1.2
(f) ensure that there is a Quality Assurance Programme with designated personnel and assure that the quality assurance responsibility is being performed in accordance with these Principles of Good Laboratory Practice;
TFM - Assure
Appropriate
Testing
58.31
(d) Assure that test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.
792.31
(d) Assure that test, control, and reference substances or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.
Section II
1.1.2
(p) ensure that test and reference items are appropriately characterised;
TFM- Assure
Availability of
Resources
58.31
(e) Assure that personnel, resources, facilities, equipment, materials, and methodologies are available as scheduled.
792.31
(e) Assure that personnel, resources, facilities, equipment, materials and methodologies are available as scheduled.
Section II
1.1.2
(n) ensure that test facility supplies meet requirements appropriate to their use in a study;
TFM - Assure
Personnel
Understand Their
Functions
58.31
(f) Assure that personnel clearly understand the functions they are to perform.
792.31
(f) Assure that personnel clearly understand the functions they are to perform.
Section II
1.1.2
(d) ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions;
TFM - Assure
Corrective
Actions
58.31
(g) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented.
792.31
(g) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented.
 
TFM - Assure
Appropriate
SOPs
    Section II
1.1.2
(e) ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and approve all original and revised Standard Operating Procedures;
TFM - Assure
Historical SOPs
    Section II
1.1.2
(k) ensure the maintenance of an historical file of all Standard Operating Procedures;
TFM- Assure there
is a PI
    Section II
1.1.2
(h) ensure, in the event of a multi-site study, that, if needed, a Principal Investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal Investigator should be done
according to established procedures, and should be documented.
TFM - Assure
there is Archivist
    Section II
1.1.2
(l) ensure that an individual is identified as responsible for the management of the archive(s);
TFM - Assure
Master Schedule
    Section II
1.1.2
(m) ensure the maintenance of a master schedule;
TFM - Clear Lines
of
Communication
    Section II
1.1.2
(o) ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel;
TFM - Validation
of Computerized
Systems
    Section II
1.1.2
(q) establish procedures to ensure that computerised systems are suitable for their intended purpose, and are validated, operated and maintained in accordance with these Principles of Good Laboratory Practice.
Test Site
Management
Responsibilities
    Section II
1.1.3
When a phase(s) of a study is conducted at a test site, test site management (if appointed) will have the responsibilities as defined above with the following exceptions: 1.1.2 g), i), j) and o).
General
Responsibilites of
a Study Director
58.33
For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control.
792.33
For each study, a scientist or other professional of
appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results, and represents the single point of study control.
Section II
1.2.1
The Study Director is the single point of study control and has the responsibility for the overall conduct of the study and for its final report.
Study Director -
Protocol
Approval &
Compliance
58.29
(a) The protocol, including any change, is approved as provided by Sec. 58.120 and is followed.
792.33
(a) The protocol, including any change, is approved as provided by Sec. 792.120 and is followed.
Section II
1.2.2.
(a) approve the study plan and any amendments to the study plan by dated signature;
(e) ensure that the procedures specified in the study plan are followed, and assess and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary; acknowledge deviations from Standard Operating Procedures during the conduct of the study;
Study Director -
Assure QAU has
Protocol
    Section II
1.2.2
(b) ensure that the Quality Assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the Quality Assurance personnel as required during the conduct of the study;
Study Director -
Assure Personnel
have Protocol
    Section II
1.2.2
(c) ensure that study plans and amendments and Standard Operating Procedures are available to study personnel;
Study Director -
Assure Personnel
have Protocol
    Section II
1.2.2
(c) ensure that study plans and amendments and Standard Operating Procedures are available to study personnel;
Study Director -
Assure PI Role
    Section II
1.2.2
(d) ensure that the study plan and the final report for a multi-site study identify and define the role of any Principal Investigator(s) and any test facilities and test sites involved in the conduct of the study;
Study Director -
Recording &
Verification of
Data
58.33
(b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
792.33
(b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
Section II
1.2.2
(f) ensure that all raw data generated are fully documented and recorded;
Study Director -
Unforseen
Circumstances
58.33
(c) Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.
792.33
(c) Unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented.
 
Study Director -
Test Systems
58.33
(d) Test systems are as specified in the protocol.
792.33
(d) Test systems are as specified in the protocol.
 
Study Director -
GLP Compliance
58.33
(e) All applicable good laboratory practice regulations are followed.
792.33
(e) All applicable good laboratory practice regulations are followed.
Section II
1.2.2
(h) sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these Principles of Good Laboratory Practice;
Study Director -
Archiving
58.33
(f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.
792.33
(f) All raw data, documentation, protocols, specimens,
and final reports are transferred to the archives during or at the close of the study.
Section II
1.2.2
(i) ensure that after completion (including termination) of the study, the study plan, the final report, raw data and supporting material are archived.
Study Director -
Validation of
Computerized
Systems
    Section II
1.2.2
(g) ensure that computerised systems used in the study have been validated;
Principal
Investigator
    Section II
1.3
The Principal Investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable Principles of Good Laboratory Practice.
QAU General
Responsibilities
Sec. 58.35
(a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part.
Sec. 792.35 Quality assurance unit.
(a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. The quality assurance unit shall conduct inspections and maintain records appropriate to the study.
Section II
2.1.1
The test facility should have a documented Quality Assurance Programme to assure that studies performed are in compliance with these Principles of Good Laboratory Practice.
2.1.2.
The Quality Assurance Programme should be carried out by an individual or by individuals designated by and directly responsible to management and who are familiar with the test procedures.
QAU
Independence
Sec. 58.35
(a) For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study.
Sec. 792.35 Quality assurance unit. (a) For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. Section II
2.1.3
This individual(s) should not be involved in the conduct of the study being assured.
QAU - Maintain
Copy of Master
Schedule
58.29
(b)
(1) Maintain a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director.
792.35
(b)
(1) Maintain a copy of a master schedule sheet of all studies conducted at the testing facility indexed by test substance and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director.
Section II
2.2.1
(a) have access to an up-to-date copy of the master schedule;
QAU - Maintain
Copies of
Protocols
58.35
(b)
(2) Maintain copies of all protocols pertaining to all nonclinical laboratory studies for which the unit is responsible.
792.35
(b)
(2) Maintain copies of all protocols pertaining to all studies for which the unit is responsible.
Section II
2.2.1
(a) maintain copies of all approved study plans and Standard Operating Procedures in use in the test facility
QAU - Verify
Content of
Protocol
    Section II
2.2.1
(b) verify that the study plan contains the information required for compliance with these Principles of Good Laboratory Practice. This verification should be documented;
QAU - Maintain
copies of SOPs
    Section II
2.2.1
(a) maintain copies Standard Operating Procedures in use in the test facility
QAU -
Inspections
58.35
(b)
(3) Inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for reinspection.
792.35
(b)
(3) Inspect each study at intervals adequate to ensure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for re-inspection.
Section II
2.2.1
(c) conduct inspections to determine if all studies are conducted in accordance with these Principles of Good Laboratory Practice. Inspections should also determine that study plans and Standard Operating Procedures have been made available to study personnel and are being followed.
Inspections can be of three types as specified by Quality Assurance Programme Standard Operating Procedures:
  • Study-based inspections,
  • Facility-based inspections,
  • Process-based inspections.
Records of such inspections should be retained.
QAU - Reporting 58.35
(b)
(3) Any problems found during the course of an inspection which are likely to affect study integrity shall be brought to the attention of the study director and management immediately. Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken.
792.35
  1.  
    1. Any problems which are likely to affect study integrity found during the course of an inspection shall be brought to the attention of the study director and management immediately.
    2. Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken.
Section II
2.2.1
(e) promptly report any inspection results in writing to management and to the Study Director, and to the Principal Investigator(s) and the respective management, when applicable;
QAU - Assure
Deviations are
Authorized
58.35
(b)
(3) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
792.35
(b)
(5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
 
QAU - Review of
Final Report
58.35
(b)
(3) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the nonclinical laboratory study.
792.35
(b)
(6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the study.
Section II
2.2.1
(d) inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies;
QAU - Final
Report
Statement
58.35
(b)
(3) Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director.
792.35
(b)
(7) Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director.
Section II
2.2.1
(f) prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phase(s) of the study inspected, and the dates inspection results were reported to management and the Study Director and Principal Investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.
QAU -
Responsibilities &
Procedures
58.35
(c) The responsibilities and procedures applicable to the quality assurance unit, the records maintained by the quality assurance unit, and the method of indexing such records shall be in writing and shall be maintained. These items including inspection dates, the study inspected, the phase or segment of the study inspected, and the name of the individual performing the inspection shall be made available for inspection to authorized employees of the Food and Drug Administration.
792.35
(c) The responsibilities and procedures applicable to the quality assurance unit, the records maintained by the quality assurance unit, and the method of indexing such records shall be in writing and shall be maintained. These items including inspection dates, the study inspected, the phase or segment of the study inspected, and the name of the individual performing the inspection shall be made available for inspection to authorized employees or duly designated representatives of EPA or FDA.
 
QAU -
Management
Certification of
QAU Inspections
58.35
(d) A designated representative of the Food and Drug Administration shall have access to the written procedures established for the inspection and may request testing facility management to certify that inspections are being implemented, performed, documented, and followed-up in accordance with this paragraph.
792.35
(d) An authorized employee or a duly designated representative of EPA or FDA shall have access to the written procedures established for the inspection and may request testing facility management to certify that inspections are being implemented, performed, documented, and followed up in accordance with this paragraph.