GLP TOPICS

GLP Protocols and Study

Conduct–It Just Takes a
Little Planning
Jeff Morgan

“GLP Topics” addresses topics associated with good laboratory practice

requirements. We intend this column to be a useful resource for daily work
applications.
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column coordinator Cindy Green at [email protected] or to managing edi-

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EXECUTIVE SUMMARY
Good laboratory practices (GLPs) have been universally recognized
as rules that govern the conduct of non-clinical safety studies. The
GLP goal is to ensure the quality, integrity, and reliability of the data
developed from such studies, which in turn allows the appropriate
assessment of the safety and effectiveness of the drug or device that is
the object of the study. The US Food and Drug Administration relies on
documented adherence to GLP requirements by nonclinical laborato-
ries in judging the acceptability of safety data submitted in support of
research or marketing permits (1). Laboratory management is respon-
sible for communicating and supporting a commitment to the reporting
of laboratory results and delivery of services in an efficient and timely
manner. The “Good” in GLP cannot happen without well thought-out
protocols and proper conduct of the study itself. This article focuses on
these two critical elements to provide a roadmap for a journey to com-
plete and compliant GLP study.

INTRODUCTION
All nonclinical laboratory studies that support, or are intended to sup-
port, applications for products regulated by FDA must adhere to 21
CFR Part 58 (2). Section § 58.120, which addresses protocol require-
ments, and § 58.130, which defines the conduct of a nonclinical labora-
tory study, are especially important sections.

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TABLE I: Elements of GLP study protocol pre-planning.

Ensure there are a sufficient number of resources (e.g., adequate budget, personnel, facilities, equipment, and materials) for the
timely and proper conduct of the study before writing the protocol.
Ensure that the study director, the quality assurance unit, and study personnel clearly understand the duties and responsibilities they
are required to perform for the study.
Develop a study protocol according to established procedures.
Audit the standard operating procedures (SOPs) to be used in the study to ensure that they are current.
Ensure that SOPs are in place to conduct the study and that they meet the requirements of the protocol. Create or revise SOPs as
deemed necessary before completing the protocol development.
Where possible, develop the protocol with analytical methods that have been established and validated.
Correspond with the sponsor and obtain the required information for the protocol to ensure that the laboratory performing the GLP
work is capable of producing quality analytical results.
Review the objectives, methodology, analytical methods, and other requirements of the protocol with study personnel. This can pin-
point areas in the protocol that will require more detailed instructions and avoid having to amend an approved protocol.

Any person who submits an application for a re- and handling, analytical methodologies, data analysis
search or marketing permit that includes data from and documentation of the study), then the template ap-
a study in connection with the application must proach may be acceptable.
include a true and correct statement that the study However, this approach is not without pitfalls,
was conducted in accordance with GLP require- because there may be a tendency for developers
ments. Admission of false information may result in using a template to actually skip over the contents,
the cancellation, suspension, or modification of an missing some key elements. Likewise, this same
approved research or marketing permit, or denial scenario may apply to those who review and ap-
or disapproval of an application for such permit. prove such documents. When this occurs, it is quite
Therefore, it is essential that the testing facility likely that the protocol will require amending after
strictly adhere to the requirements of GLP and the its initial approval, often because the individuals
approved study protocol. who must execute the protocol have encountered a
Although it is not required by regulatory require- problem in the documentation.
ments, studies not intended for submission should Developers of any protocol should strive to mini-
be conducted in a manner comparable to GLP. mize, if not eliminate, the need for amendments. Keys
Maintaining a standard of compliance assures that to strategically pre-planning a well-developed protocol
regulatory studies, when conducted, are not nega- are found in Table I.
tively impacted. Protocols developed for a nonclinical laboratory
study should comply with a standard format and con-
PRE-PLANNING AND tent to ensure that all elements are addressed. Failure
DEVELOPING A SUSTAINABLE PROTOCOL to have such requirements is another reason for having
Much has been written about protocol development to amend the study protocol. The study director, who is
with regard to format and content. Developing proto- responsible for designing the protocol format and con-
cols is a time consuming and costly endeavor to the tents, can then assign the task of protocol preparation
extent that facilities often use “cookie cutter” templates to appropriate personnel and monitor its development.
for their development. If the GLP study is similar to The protocol for a nonclinical laboratory study must
that of a previously performed protocol (with regard provide specific information required to properly con-
to the study goal, risks, populations, sample collection duct the study. The protocol must clearly state the

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TABLE II: Example of items for a pre-development checklist.

Inspect the areas of the testing facility where the study is to be conducted. Ensure there is adequate space and sufficient separation
from any concurrent function or activity that may have an adverse effect on the study.
To prevent contamination or mix-ups of the test and control articles and their mixtures, establish separate areas away from the housing
of the test system for:
• Receipt and storage of the test and control articles
• Mixing of the test and control articles with a carrier
• Storage of the test and control mixtures
Ensure equipment used in the generation, measurement, or assessment of data as well as the equipment used for facility environmental
control are of appropriate design and have the adequate capacity to function according to the protocol.
Place the equipment, if necessary, in areas that allow easy access for operation, inspection, cleaning, and maintenance.
Prior to development of the protocol and use in conducting the GLP study, ensure specified parameters have been developed, vali-
dated, or verified for each unit.
Establish schedules for routine inspection, cleaning, maintenance, testing, calibration, or standardization.
Establish procedures for the action to be taken in the event of failure or malfunction of equipment.
Provide for the appropriate collection, storage, and disposal of waste materials. Review safety requirements of the study with study
personnel.
Review the SOP index and representative samples of SOPs to ensure that written procedures exist to cover all of the required test
article collection, storage, handling, shipment, receipt, logging, analytical methodologies, quality control and what to do in the event
of out-of-specification results.
Verify that only current SOPs are available at the personnel workstations.
Make significant changes to approved SOPs according to established procedures. Verify that changes to SOPs are properly authorized
and dated and that a historical file of SOPs is maintained.
Review key SOPs in detail and check for proper authorization signatures and dates, and general adequacy with respect to the content
(i.e., SOPs are clear, complete, and can be followed by a trained individual).
Ensure that there are procedures for familiarizing employees with SOPs.
Determine that there are SOPs to ensure the quality and integrity of data, including input (data checking and verification), output
(data control), and an audit trail covering all data changes.
Verify that a historical file of outdated or modified computer programs is maintained in digital form.
Verify that SOPs are periodically reviewed for current applicability and that they are representative of the actual procedures in use.
Review selected SOPs and observe employees performing the operation to evaluate SOP adherence and familiarity.
Do not deviate from a SOP without proper authorization by the study director. Document all deviations in the raw data.
All protocols new and/or amended shall be reviewed and approved by the study director and appropriate management in quality assur-
ance prior to use.

objectives, methodology, and analytical methods PRE-DEVELOPMENT CHECKLIST

used for the analysis of collected data necessary to Human nature often invites developers of the study pro-
assess the test article. tocol to rush headlong into its development only to find
Only testing facility personnel with the scientific that several edits and revisions of the draft are necessary
education and experience appropriate to the type of due to omissions of critical elements. It is well worth the
study to be conducted should have authorization to investment in time to prepare a pre-development check-
participate in the preparation of the study protocol. list (Table II) in addition to the overall strategic plan.

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PROTOCOL DEVELOPMENT onstrate compliance with the regulations and

Prior to drafting the protocol for the study, a unique monitor environmental controls according to
number should be assigned to the protocol. The established procedures.
assigned number serves to identify the test article; • Upon receipt of test and control articles, check
to accurately record, track, and account for data and the label on each storage container for name,
records generated during the study; and to ensure chemical abstract number or code number,
collected data and information remain unbiased in batch number, expiration date (if any), and stor-
their interpretation. All protocol numbers are gener- age conditions.
ally assigned by the quality assurance unit (QAU), • A ssign storage containers to hold the test article
which also maintains a list of the protocol numbers for the duration of the study and ensure that
and titles. test and control articles or mixtures have been
Development and drafting the protocol for all appropriately tested for identity, strength, puri-
nonclinical laboratory studies is then initiated. The ty, stability, and uniformity, as applicable.
draft document is circulated for review and com- • Ensure that all test articles, reagents, controls
ment by subject matter experts or key study partici- and associated test materials are well cataloged
pants. The suggested elements and requirements for as to their location and quantity. Remember, at
a protocol are found in Table III. It is recommended any time during a study, the quality assurance
that a statistician prepare the statistical analysis department and the study director must be able
plan for inclusion in the protocol. to locate these items.
• Follow procedures for test and control article
WHEN THE PROTOCOL IS UNDERWAY receipt and distribution in order to maintain
There are fundamental rules for performance by proper identification and to prevent contamina-
laboratory personnel when executing the protocol. tion, deterioration, or damage.
These include the following: • Document all receipts and withdrawals of
• Do not use unidentified, deteriorated, or out- inventory on appropriate accountability
dated reagents or solutions. records.
• Inspect, clean, and maintain equipment used • Perform appropriate analytical methods for
for the generation, measurement, or assessment each test or control article that is mixed with a
of data according to schedule. carrier to determine the uniformity of the mix-
• Test, calibrate, or standardize equipment as ture, concentration of the test or control article
required in established procedures, maintain- in the mixture, and the stability of the test and
ing written records of all inspections, main- control articles in the mixture as required by
tenance, testing, calibrating, or standardizing the protocol.
operations.
• If equipment used in the GLP study malfunc- Extended Studies
tions, maintain records for the non-routine It is good practice for studies greater than four
repair performed and any remedial action weeks duration to reserve samples from each batch
taken in response to the malfunction, as well as of test and control article according to regulatory
performing an assessment of the impact of the requirements. Identify collected specimens by test
malfunction on the study. system, study, nature, and date of collection. Label
• Handle and dispose of waste materials accord- the specimen container in a manner that minimizes
ing to federal, state, and local requirements the potential error in the recording and storage of
and follow the applicable safety requirements data. When using an automated data collection
as described in the material safety data sheets system, ensure the individual responsible for direct
(MSDS). Record all of these activities to dem- data input is identified at the time of data input.

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TABLE III: Suggested protocol elements and requirements.

Element Requirements

Cover page Title of study

Protocol number/contract number
Sponsor’s name/address/telephone number(s)
Testing facility’s name/address/telephone number(s)
Protocol approval date to include signature of study director and signature of sponsor
Table of contents List the contents by description, section, and page number.
Introduction Provide background information of the test article (i.e., information from literature).
Objective State the purpose for the study and the expected outcome.
Test and control article Identifying of the test and control articles by name, chemical abstract number, or code/lot num-
ber. More detailed information may be given in this section including molecular formula, molecular
weight, purity, appearance.
Criteria for collection of samples outside the scope of the study (i.e., future research).
Proposed start and The starting date is the date the protocol is signed and dated by the study director and the comple-
completion date tion date is the date the final report is signed by the study director.
Product supply and storage Record standards or reagents supplied by the sponsor. Indicate the location of the test article sample
and any sponsor supplied standards or reagents. Include storage conditions. Specify the quantity of
product to be used in the study.
Test system description Where applicable, provide the number, body weight range, sex, source of supply, species, strain, sub-
strain, and age of the test system.
Test system identification Describe the procedure for identifying the test system during the course of the study. If using cage
cards in the study, the information to be included on the cards may be described in this section.
Test system justification Provide a direct statement to explain the reasoning for choosing the test system for the test article
(optional) assessment.
Experimental design Present a clear and well organized experimental design that describes the conditions under which the
study will be conducted.
Provide timelines showing the various phases of the study and timing requirements for specific tests
and procedures. Include a proposed schedule of the critical phases of the study to assist the quality
assurance unit with scheduling inspections.
Describe the frequency and methods for monitoring the study.
Provide the methods for the control of bias. This includes instructions to follow in cases where,
based on the outcome of the various phases of the study, revision to the methodology is required from
the original design. Describe the options and the rationale for making any change.
Diet and vehicle Describe and identify the diet used in the study. Include solvents, emulsifiers, or other materials
used to solubilize or suspend the test or control articles before mixing with the carrier. Include speci-
fications for acceptable levels of contaminants that are reasonably expected to be present in the
dietary materials and are known to be capable of interfering with the purpose or conduct of the study
if present at levels greater than established by the specifications.
Route of administration Describe the route of administration of the test article into the test system (i.e., gavage, dermal
absorption, injection).

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TABLE III: Continued.

Dosage level Describe each dosage level, expressed in milligrams per kilogram of body or test system weight
or other appropriate units, of the test, control, or reference substance to be administered and the
method and frequency of administration.
Tests and analyses List the type and frequency of tests, analyses, and measurements to be made during the study. The
list is used by quality assurance to assure completion of the study record and in selecting records for
auditing the final report.
Documentation List the records to be maintained by the testing facility and their format. Records include raw data,
all subsequent analyses, correspondence related to discussions on study conduct and results, speci-
mens, and supporting documentation.
Describe the record storage requirements applicable to the testing and sponsor sites.
Statistical methods Describe the statistical methods to be used.
Include justification for the sample size.
Statistical analysis Describe the type of data to be analyzed
Include time frames for completion
Clarify any special or interim analyses to be completed
Accountability of product Describe the packaging, label contents, coding, etc. of the test, control, and reference substances.
Include procedures for receipt, handling, and shipping, if any.
Include procedures for final disposition of the sponsor test, control, and reference substances after
completion of study.
Appendices Attach tables, figures and description of special procedures.
References Include current bibliography.

PROTOCOL DEVIATION REPORTING after the occurrence or after becoming aware of the
Referred to here are unplanned deviations. Most will incident). Maintenance of a protocol deviation report
agree that a protocol that necessitates a so-called log is often the responsibility of quality assurance or
“planned deviation” is poorly conceived and is lacking under the administration of the study director, who
in planning—meaning it should never have left the is ultimately responsible for review and approval of
launch pad. protocol deviation reports. A sample protocol devia-
Deviations from protocols are, unfortunately, not tion report is found in Figure 1.
uncommon events. Human error is generally the In addition, the study director must also review
culprit lurking behind a deviation. While it is best to and approve summary and trend analysis reports,
avoid deviating from the prescribed activities defined recurring deviations, and effectiveness of corrective
in the protocol, strategies must be made in advance for actions as well as ensure timely completion of correc-
efficient and expeditious management of these events. tive actions identified in protocol deviation reports.
It is essential to provide a mechanism for docu- Summary and trend analysis reports are important in
menting exceptions from approved methods de- discovering recurring deviations and effectiveness of
scribed in a protocol for a nonclinical laboratory corrective actions.
study. All unplanned deviations must be recorded The following are two basic reasons for most
and specifically assigned an identifier by which it deviations:
can be used in creation of a deviation report and for • The source of the deviation is internal, where the
tracking and trending. The supervisor of the as- people responsible for conducting the study have
signed area must immediately be notified when the created (unwittingly) the set-up for deviations to
deviations occur (preferably no later than 24 hours occur

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Figure 1:
ExampleFigure: Example
protocol deviation report. protocol deviation report.

Protocol  Deviation  Number:    

 Planned              Unplanned            Date:                                                    Requested  by:  

Protocol  or  Protocol   Report  No.                                                     Assigned  by:  

Amendment  No.                                

Description  of  Deviation:  

 

Cause  (if  known):  

 

Proposed  Corrective  Action:    

 
By:____________________________________________    Date:  ___________________________  

Corrective  Action  Taken:  

 
By:____________________________________________    Date:  ___________________________  

Corrective  Action  Completed:  

 
By:____________________________________________    Date:  ___________________________  

Effectiveness  of  Corrective  Action  Verified:  

 
By:____________________________________________    Date:  ___________________________  

Protocol  Amendment  Required?  

   No                  Yes  Date  Assigned:_______________    Assigned  to:  _________________________  

Future  Action:  
 
By:____________________________________________    Date:  ___________________________  

Final  Approval:  
Quality  Assurance:  _______________________________    Date:  ___________________________  

Study  Director:  __________________________________    Date:  ___________________________  

 

 
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• The source of the deviation is external, where the data can and have led to serious errors in an oth-
participants in the study fail to follow instructions. erwise good study. This is where logs and training
records become invaluable. Call logs, training logs,
Internal Sources of Deviations written communication and responses should be
Internal sources of deviations further fall into the developed so that communication is clear and con-
following categories: cise, and can be traceable, not only to avoid devia-
• Poor planning. Examples include incorrect or tions, but as a tool in investigating the root cause
insufficient quantities of study supplies, poor of deviations. Additional root causes for deviations
quality study supplies, unprepared study sites, from an approved protocol are found in Table IV.
study sites incorrect (i.e., cannot handle the vol-
ume, have insufficient storage or clinical facilities), External Sources of Deviations
and facilities issues (i.e., insufficient cold storage External sources of deviations are similar in nature to
for samples, problems with validated systems, those mentioned with internal issues, but an additional
including system failures that may impact product layer of problems may occur if written instructions to
quality or may require increased environmental patients have not been “road tested” by non-clinical
monitoring). personnel for clarity and understanding to determine
• Insufficient training. Examples include the lack how easy the instructions are to follow. This is a big
of specialized individuals to process and evalu- challenge, because well-written subject instructions
ate specimens taken from patients during a study can make or break a study.
(i.e., ensuring serum samples are not hemolyzed For example, during one study, the subject was
or being aware of how to judge whether lipemia or responsible for collecting a 24-hour urine sample and
specimens with high bilirubin may interfere with was given instructions written by a medical profession-
test results). Training can also relate to counsel- al. During the evaluation of data, the patient appeared
ing a study subject on a variety of issues such as to be an outlier because the analyte in the urine was
fasting before blood draws, timing of taking study extremely elevated. However, as the data were further
medications, proper collection of in-home samples scrutinized, it became apparent that the patient under-
or spotting a problem that could lead to disquali- stood that the sample was to be taken once, and again
fying a subject, such as excessive weight gain. 24 hours later instead of collecting all urine output over
• Lack of experience. While experience must be 24 hours. The error was discovered because the sample
thoroughly assessed during the selection of study volume was consistent with a patient with kidney
sites, it is possible that through employee turnover failure, but the blood work showed just the opposite.
the individuals in place during the site assessment The takeaway from this is if the patient is given written
may have moved on at some point in the study. instructions, they need to be written in “patient-ese”
It is important for the study director to be kept and not with confusing, conflicting medical terminol-
appraised of any study site personnel changes and ogy or jargon.
evaluate the experience of the replacement per- One-off deviations can and will occur. However,
sonnel to ensure optimal quality throughout the when the same category, cause, or class of deviation
study’s lifecycle. recurs, then a larger issue is introduced. Not only is the
• Poor communication. Most problems of this reason for the present problem important to discover,
nature arise from assumption. Nonclinical labora- the reason for the recurrence must also be pinpointed.
tory studies are expensive, time consuming, and Repeat problems or deviations must first be completely
must be exact in the execution. Assumptions by dissected for the root cause, reviewed for previous
the study director or sponsor regarding the avail- attempts at corrective and preventive action, analyzed
ability of supplies, proper study subject prepara- to discover why the corrective and preventive action
tion, managing the subjects and their samples and was inadequate, and re-evaluated to permanently fix

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TABLE IV: Common root causes for deviations from an approved protocol.
Material Use of non-conforming material or reference standards where the testing and specification have been
validated; includes the use of expired material.
Method Use of an inadequately validated method.
Document Use of a SOP (i.e., redlined) that is not approved for use.
Operator Errors made by study personnel or instances of not following approved procedures (without an approved
protocol deviation report).
Equipment Equipment or facility breakdowns, failures, or instruments found to be out of calibration.
Environment Air, surface, or water sampling results out of specification.
Schedule Departure from established schedules such as environmental monitoring, preventive maintenance, and
calibration programs.
Validation/qualification Use of equipment or method inadequately validated or qualified, or specifications established without
adequate supporting data.
Vendor Changes in vendor supplied product (i.e., documentation or certification of purchased parts, changes in
product specifications, changes in packaging), inability to deliver pre-shipment samples, and contract
test lab errors.

the situation. Retraining the retrained is not a viable apparent, indicate the need for further investiga-
option. tion to determine corrective action or indicate that
Well-trained area supervisors should possess the the QA unit or the study director will determine
proper skills for determining the cause of the devia- the corrective action.
tion within their area and recommending appropri- • Review the report with QA to determine the
ate corrective action. While deviation investigation impact of the deviation on the study. Obtain and
techniques are beyond the scope of this article, it is record approval by QA for the report. Confirm
sufficient to say that using tried and true root cause the cause of the deviation and determine the next
analysis should be in an area supervisor’s toolkit. course of action.
• Do not accept any planned deviation that has a
IF YOU HAVE TO DEVIATE, DO IT CORRECTLY significant effect on the study. The study direc-
The following are recommended when deviations are tor must evaluate these deviations prior to their
necessary: potential implementation.
• Evaluate the deviation to determine whether the • Review each protocol deviation report to deter-
deviation could affect the data collected for the test mine whether the deviation described should be
article or otherwise corrupt the study data. If this permanently incorporated into the protocol. If it is
is the case, send the report to the study director for determined that the deviation should be incorpo-
review, discussion, and approval. If the deviation rated, amend the protocol according to established
report is approved, return the report to the quality procedures. Significant repeated unauthorized
assurance (QA) department for inclusion in the protocol deviations by a testing facility will war-
final study report. rant further investigation by the sponsor and may
• Recommend and assign a corrective action in the result in termination or suspension of the testing
report to prevent the future occurrence of devia- facility’s participation in the study. The takeaway
tions due to the same or similar reason. here is that any deviation is a serious event and
• Describe the corrective action specifically to allow requires the utmost attention to detail.
verification. If the corrective action is not yet

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PROTOCOL AMENDMENTS
TABLE V: Suggested content of a protocol amendment.
A protocol amendment is prepared when any perma-
nent modification to the objective, methodology, or Protocol number
analytical methods of the approved protocol is planned Protocol amendment number
and initiated. Date of protocol amendment
The Code of Federal Regulations succinctly directs Study title
what must be done in the event of a change to a
Nature of the revisions with reference to the applicable sections
protocol: of the protocol
“All changes in or revisions of an approved protocol
Reason for protocol amendment
and the reasons therefore shall be documented, signed
by the study director, dated, and maintained with the Name of individual initiating the amendment
protocol” (3). Signatures indicating approval of the amendment
When an amendment is necessary, inform the QAU Dated signature of individual responsible for filing the
of the proposed change prior to initiating and imple- completed document
menting the protocol amendment. Make amendments to
approved protocols according to established procedures
and request QA to assign a number for the amendment,
generally by assigning the number of the corresponding with safety and effectiveness to the patient. Thorough
protocol followed by a numeric suffix. For example, assessment, communication, pre-planning, and an
DEV-1-01 WOULD INDICATE THE FIRST AMEND- adherence to basic elements of protocol development
MENT FOR THE PROTOCOL NUMBERED DEV-1. and execution practices may seem on the surface to be
Subject the protocol amendment to the same review overkill, but will save time and expenses in avoid-
and approval requirements as those of the original ing protocol false-starts, numerous amendments, and
protocol. Include the same individuals in the review of potential deviations that can derail an otherwise good
the amendment that were responsible for review and study. Taking the time to get it right the first time is
approval of the original protocol. a guaranteed advantage over poorly or inadequately
Typical information to be included in a protocol prepared protocols or inadequate GLP resources, inef-
amendment is shown in Table V. ficient laboratories, or confused study participants. It’s
After the amended protocol is returned, incorporate just the right thing to do.
recommendations and circulate the revised protocol
for review and approval. Obtain the dated signature of REFERENCES
the study director to indicate approval of the amended 1. FDA, Food and Drug Administration Compliance Program
protocol. If necessary, obtain the dated signature of the Guidance Manual, Chapter 48–Bioresearch Monitoring, Good
sponsor. Laboratory Practice, February 21, 2001.
Once approved, submit original protocol amend- 2. FDA, 21 CFR Part 58-Good Laboratory Practice for Nonclini-
ments to the study director and a copy to the spon- cal Laboratory Studies.
sor. Maintain and control the original approved study 3. FDA, 21 CFR 58.120(b).
protocol and all approved protocol amendments in an
organized manner within the QAU files according to GENERAL REFERENCE
applicable regulatory requirements. WHO, Handbook: Good Laboratory Practice (GLP): Quality Practic-
es For Regulated Non-Clinical Research And Development-2nd
CONCLUSIONS edition, UNDP/World Bank/WHO Special Programme for
GLP study protocols and their conduct are critical Research and Training in Tropical Diseases (TDR), World
in the accurate and reliable assessment of whether a Health Organization, Geneva, 2009. GXP
given drug or device will meet its goal of intended use

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GLOSSARY ARTICLE ACRONYM LISTING

Good Laboratory Practice. A standard that ensures the FDA US Food and Drug Administration
quality of nonclinical laboratory studies, both in vitro GLP Good Laboratory Practice
and in vivo, and of the resultant data. QA Quality Assurance
Nonclinical Laboratory Study. Any in vivo or in vitro QAU Quality Assurance Unit
experiments in which test articles are studied pro- QC Quality Control
spectively in test systems under laboratory conditions SOPs Standard Operating Procedure
to determine their safety. The term does not include
studies utilizing human subjects, or clinical studies, ABOUT THE AUTHOR
or field trials in animals. Jeff Morgan, president and principal of JWM Associates LLC,
has assisted both international and domestic medical device,
Protocol. A document that describes the design, ob-
biopharmaceutical companies, and clinical laboratories since
jectives, methodology, statistical considerations, and 1998. JWM Associates helps clients in quality systems compli-
organization of a nonclinical laboratory study. ance, medical device regulatory approval, FDA compliance
Quality Assurance Unit. Any person or organizational troubleshooting, food supplement regulation compliance, and
element designated by management of the testing clinical laboratory certification. Jeff may be contact by phone at
253.208.3430 and e-mail at [email protected].
facility to perform the duties relating to quality assur-
ance of nonclinical laboratory studies.
Sponsor. A person who initiates and supports a non-
clinical laboratory study, who submits a nonclinical
study to the FDA in support of an application for a
research or marketing permit, or a testing facility that
both initiates and conducts the study.
Testing Facility. An individual, partnership, corpora-
tion, association, scientific or academic establish-
ment, government agency, or organizational unit
thereof, and any other legal entity who actually con-
ducts a study, and uses the test substance in a test
system. Testing facilities are operational units that
are being or have been used to conduct studies.

64   Journal of GXP Compliance