GLP TOPICS
Testing Facility Management
for GLP Testing
BBS UNITED, ALEX HAYDEN/GETTY IMAGES
Cindy Green
“GLP Topics” addresses topics associated with good laboratory practice
requirements. We intend this column to be a useful resource for daily work
applications. The key objective for this column: Useful information.
Reader comments, questions, and suggestions are needed to help us fulfill
our objective for this column. Please send your comments and suggestions to
column coordinator Cindy Green at cindynwrs@seanet.com or to journal coordinating editor Susan Haigney at shaigney@advanstar.com.
KEY POINTS
The following key points are discussed:
•Testing facility management is the person(s) who has the authority
and formal responsibility for the organization and functioning of
the testing facility according to the principles of good laboratory
practice
•A testing facility will have three levels of management: facility
management, study personnel, and quality assurance program staff
•The US Food and Drug Administration has stipulated that the quality assurance unit shall be entirely separate from and independent
of the personnel engaged in the direction and conduct of that study
•Qualifications and responsibilities of management are described
•Requirements of management are discussed
•Management should be prepared to field inspections and audits and
to provide specific documents when requested
•Testing facility management has ultimate responsibility for the
operating of the testing facility including oversight of all studies
planned and executed at the facility
•There are five important principles of good laboratory practices:
resources, characterization, rules (protocols and reports), results,
and quality assurance.
INTRODUCTION
What, exactly, is “Testing Facility Management?”
According to the World Health Organization’s GLP handbook, testing
facility management is “the person(s) who has the authority and formal
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Cindy Green
responsibility for the organization and functioning
of the test facility according to the principles of good
laboratory practice” (1).
Management of a testing facility may involve more
than one person in more than one location. The
particular management level to whom a study director
reports has the ultimate responsibility for ensuring that
the facilities operate in compliance with the principles
of good laboratory practice (GLP). But even in the
simplest case, a testing facility will have three levels
of management. These include facility management,
study personnel, and quality assurance program staff.
In any endeavor with multiple levels of management,
it is absolutely critical that clear lines of authority and
communication are established and that responsibilities are assigned. It is the responsibility of the testing
facility management to ensure that clear lines of communication exist and that these lines of communication are clearly documented.
MANAGEMENT QUALIFICATIONS AND
RESPONSIBILITIES
Before delving into who the management person(s)
can be and what that person’s responsibilities are,
perhaps a quick discussion of who that person cannot be is in order.
A question often asked is whether the study director
can also hold a management position in the testing
facility. The US Food and Drug Administration has
stipulated in 21 CFR, Part 58, Subpart B, Section 58.35
that “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” (2). Based on this regulation, FDA has answered the question with a resounding “No.” It may be
inferred from this that for study personnel, such as the
study director, to also have a management role would
violate the “entirely separate from and independent of”
requirement because management does oversee the
quality assurance unit (2).
Qualifications
So who can qualify as testing facility management?
According to 21 CFR, Part 58, Subpart B, Section
58.29, “Each individual…responsible for the super-
vision of a nonclinical laboratory study shall have
education, training, and experience, or combination
thereof, to enable that individual to perform the assigned functions”(2).
Of course, from the discussion above we could
add that they must not be involved in the actual
conduct of the study itself.
Responsibilities and Requirements
What are the responsibilities of the testing facility
management?
Overall, management has the responsibility for
the organization of the testing facility. Although
testing facility management is permitted to delegate
designated control activities through the organization, management is required to always maintain
overall responsibility. Beyond the organizational
responsibility, however, probably first and foremost is that management is ultimately responsible
for ensuring that the facility as a whole operates
in compliance with the principles of good laboratory practice. At a minimum, management should
ensure that their facility is compliant with the GLP
principles described as follows.
Organizational chart. A statement should exist,
such as an organizational chart, that identifies the
individual(s) within the testing facility who fulfill
the responsibilities of management. It should be
noted that often the first document requested by
national monitoring authorities is the organizational chart. It is this document that describes how the
facility functions.
Master plan. A sufficient number of qualified personnel, appropriate facilities, equipment,
and materials should be available for the timely
and proper conduct of the study. The planning
and resource allocation system required by GLP
is generally referred to as a master plan or master
schedule. According to the WHO GLP handbook,
the master plan or schedule, no matter what form
it takes, must ensure that all studies, contracted or
in-house, are included. It must ensure that change
control reflects changes in dates and workload, and
that activities such as protocol review and report
preparation are allocated sufficient time. FurtherWinter 2011 Volume 15 Number 1
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GLP TOPICS
more, the system must be the “official” one (no
competing systems for the same purpose), and it
must be described in an approved standard operating procedure (SOP).
Personnel records. A record of the qualifications, training, experience, and job description for
each professional and technical individual should
be maintained.
Personnel function. Personnel should clearly
understand the functions they are to perform and,
where necessary, be provided training for these
functions.
Procedures. Appropriate and technically valid
SOPs should be established and followed, and all
original and revised SOPs should be approved.
Quality assurance. A quality assurance program with designated and adequately trained
personnel should be established. The quality
assurance responsibility should be performed in
compliance to the principles of good laboratory
practice.
Study director. A study director with the
appropriate qualifications, training, and experience should be designated for each study before
the study is initiated. A study director should be
replaced, if necessary, according to established procedures and should be properly documented.
Principal investigator. For a multi-site study,
a principal investigator should be designated. The
principal investigator should be appropriately
trained, qualified, and experienced to supervise the
delegated phase(s) of the study. A principal investigator should be replaced, if necessary, according
to established procedures and should be properly
documented.
Study plan. The study director has approved the
study plan and has made the approved study plan
available to the quality assurance personnel.
SOP historical file. A historical file of all SOPs
should be maintained.
Archives. An individual should be designated
who is responsible for the management of the
archive(s).
Master plan maintenance. The master plan or
schedule should be properly maintained.
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Supplies. The testing facility supplies should meet
the requirements appropriate to their use in a study.
Communication. For a multi-site study, clear
lines of communication should exist between the
study director, principal investigator, the quality
assurance program(s), and study personnel.
Characterization of test and reference items.
Test and reference items should be appropriately
characterized.
Computerized systems. Procedures should be in
place to ensure that computerized systems are suitable for their intended purpose and are validated,
operated, and maintained in accordance with the
principles of good laboratory practice (2).
AUDIT READINESS
In addition to the overall compliance with the principles of good laboratory practice (2), management
should be prepared to field inspections and audits
and to provide specific documents when requested.
According to the WHO GLP handbook (1), testing
facility management should be prepared to produce
the following documents for inspection:
•Floor plans
•Facility management and scientific organization
charts
•C Vs of personnel involved in a study
•List(s) of ongoing and completed studies with
information on the type of study, initiation and
completion dates, test system, method of application of test substance, and name of the study
director
•Staff health surveillance policies
•Staff job descriptions and staff training programs and records
•A n index to the facility’s SOPs
•Specific SOPs as related to the studies or procedures being inspected or audited
•List of the study directors and sponsors associated with the study being audited.
TESTING FACILITY OPERATIONS
Testing facility management has ultimate responsibility for the operating of the testing facility. This
includes the oversight of all studies planned and
Cindy Green
executed at the testing facility. If the testing conducted at the testing facility is under contract (i.e.,
external companies, organizations, facilities request
contract services from the testing facility), the testing facility is still responsible for assuring that the
test articles and controls have been properly characterized and the characterization is documented.
This does not necessarily mean that the testing facility management is responsible for reviewing and
determining the adequacy of the characterization of
test and control articles; however, it does mean that
testing facility management must ensure there is a
system in place to assure that those knowledgeable
in the review of the test and control article characterization have satisfactorily completed the review.
In addition, it is the responsibility of testing facility
management to ensure that the test and control
articles have been approved for use in the planned
GLP studies. This process of assurance that the
test and control articles have been approved must
be documented, and the records of the review and
approval must be included in the study files.
sonnel, careful preparation and review of protocols
and testing procedures, validation or verification of
test methods, qualification of materials, qualification
of testing laboratories, handling and care of animals
(i.e., test systems), validation of software, statistical
techniques for sampling and data analysis, monitoring of studies by the quality assurance unit, and
much more. The oversight and control of all aspects
of GLP studies conducted by the testing facility are
the responsibility of testing facility management.
SUMMARY
In summary, there are five important principles
of good laboratory practices. These are resources,
characterization, rules (i.e., protocols and reports),
results, and quality assurance (3).
Testing facility management has a significant responsibility in the management of studies conducted
in or by the testing facility. Adequate controls must
be in place to assure the data integrity, which is
absolutely vital to the usability of GLP studies to support product safety. To assure data integrity, there
are many controls required including equipment
calibration and maintenance, training of study per-
FDA GLP
SOP
WHO
REFERENCES
1. WHO, Handbook–Good Laboratory Practice (GLP), UNDP/World
Bank/WHO.
2. FDA, 21 CFR Part 58, Good Laboratory Practices, Title 21—
Food And Drugs Chapter I—Food And Drug Administration,
Department Of Health And Human Services, Subchapter A—
General, PART 58 Good Laboratory Practice for Nonclinical
Laboratory Studies, 43 Federal Register 60013, Dec. 22, 1978.
3. WHO, Good Laboratory Practice (GLP) – Training Manual, 2nd Edition, WHO, 2008. GXP
ARTICLE ACRONYM LISTING
US Food and Drug Administration
Good Laboratory Practice
Standard Operating Procedure
World Health Organization
ABOUT THE AUTHOR
Cindy Green, RAC, has been working with regulated industry for
nearly 35 years holding senior positions in regulatory, quality assurance, and quality control for several biotechnology and medical
device companies. She has been president of her own consulting
company for the past 18 years. Cindy can be reached by e-mail at
cindynwrs@seanet.com.
Winter 2011 Volume 15 Number 1
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