Originally Published MDDI January
2005
Quality
Good Laboratory Notebook Practice
Laboratory notebooks can be an integral part of a company’s controlled
documentation but must be managed carefully to ensure quality.
John A. DeLucia
 |
| Manufacturers
must consider many factors during a product’s development to ensure proper end-use of the device. |
Controlled documentation is a vital component of a quality system. Its benefits
include information availability, knowledge preservation, and controlled review
and approval of revisions and obsolete documents. Typically, controlled documents
may include work instructions, procedures, policies, product drawings, and specifications.
Laboratory notebooks are sometimes neglected; but their information can be used
in the documentation required in FDA-regulated industries.
Laboratory notebooks can be a primary source for documenting raw data generation
for the test engineer and laboratory technician. The notebooks also are used
for recording patented inventions and concepts. Laboratory data not otherwise
controlled by standard operating procedures or test forms also can be recorded
in the notebooks. Such data include, but are not limited to, laboratory data
resulting from product development, failure investigations, complaint investigations,
product validations, or competitive product testing to support marketing claims.
Any individual in a company who is required to gather data could use a laboratory
notebook successfully. However, generally, individuals who use laboratory notebooks
are from research and development, quality engineering, manufacturing engineering,
and testing laboratories departments.
Good Laboratory Notebook Practice
Good laboratory notebook practice is just one way to comply with the much larger
concept of good laboratory practice. FDA promulgated the good laboratory practice
(GLP) regulations, 21 CFR Part 58, on December 22, 1978. The regulations became
effective in June 1979 and established standards for the conduct and reporting
of nonclinical laboratory studies. The regulations are intended to ensure the
quality and integrity of safety data submitted to FDA.1 GLP addresses
the documentation of research. It provides a means of ensuring that all work
is done according to agreed procedures and that the data are properly recorded.
The recommendations in this article are designed to help companies develop procedures
for good laboratory notebook practice. Moreover, these recommendations can be
adapted to develop a procedure for a particular company.
Laboratory Notebook
A laboratory notebook is a permanently bound, rigidly constructed book that
can protect its contents in a laboratory environment. Typically, notebooks are
issued by the document control department and are tracked and controlled by
a serial number. When issued to laboratory workers, the serial number is entered
on the cover of each notebook along with the recipient’s name and the date
the notebook was issued. The serial number should also be noted in a log maintained
by the document control department. Once issued, the user should write his or
her name and the title of project or purpose of the notebook on the front page.
The notebook should also contain a table of contents that includes a listing,
by page number, of all experiments or entries. A space should be provided where
report titles or numbers can be entered. On each page, the user should state
the report title and project number, laboratory notebook number, and page number.
Each page should have a space for a “performed by” signature and date.
If the page describes a potential patented product or process, the inventor
should sign an “invented by” signature space. A “witnessed by”
or “reviewed by” signature and date also should be required on each
page. A witness is defined as a member of the organization who can objectively
review the information, but who is neither a coinventor nor integrally involved
in data collection. Notebooks are available that have a preprinted table of
contents, report description, page entry, and signature lines.
Data Entry
Various data entries may be made in a laboratory notebook. The more prevalent
practice uses the laboratory notebook to document an experiment and collect
test data. So it is worthwhile to look at the proper documentation practices
involved in this activity.
Before recording any data, a standardized format should be used to make entries.
The list below outlines the information that should be included.
Purpose and Objectives. The purpose and objectives section should include a
statement about or definition of the experiment. This section identifies anticipated
outcomes and provides an action plan to achieve the outcomes.
Test Articles. A description of all test articles must be written in the laboratory
notebook. It is important to provide the test-sample lot numbers and reference
any documents that contain the complete history or traceability of the test
articles. For instance, if the protocol assesses a newly designed component,
minimum information would include the component specification number, revision
level, supplier, lot or control number, purchase order number, supplier shop
order record, and a copy of the certificate of compliance. All test samples
should be retained until after the work has been witnessed in the notebook.
If the test samples are to be archived, the archive location should be indicated
in the laboratory notebook.
Test Preparation. The test preparation section is where the relevant test methods,
equipment, and conditions must be described. All laboratory equipment must be
identified by type, manufacturer, and model or tool number. It is important
to verify that the calibration and preventive maintenance are current on all
equipment.
All test methods and test specifications must be described in detail. This can
be done by referencing previously approved and issued documents (including revision
levels) or by referencing previous laboratory notebook entries by notebook number
and page. Environmental conditions, which may be important and relevant to a
test, should be noted. It is important to describe all conditions relevant during
testing, such as room temperature, humidity, or sample conditioning. All monitoring
equipment used to collect environmental data must be identified in the same
way. Laboratory equipment used in the study must also be included.
Test Results. Minimum requirements for collecting test information include entering
test results with units. All data transformations, calculations, or operations
performed on the data need to be described. Statistical analysis of the data
should be carried out according to the prospective protocol instructions and
recorded in the notebook before performing the analyses on the data set. A summary
of the test results with conclusions should be included in this section. If
inconsistent results or unusual data points were encountered, then these must
be identified and explained. Lastly, study initiation and completion dates also
should be documented.
Maintenance of Data Integrity. Maintaining data integrity is critical to good
laboratory notebook practice. It is important to write legibly and clearly and
to use recognizable and accepted terms. If abbreviations, code names, trademarks,
trade names, or numbers are used, they should be defined at least once, at first
use, in every notebook. As with any quality record, errors should be deleted
by drawing a single line through the error that does not render the deletion
illegible. A notation stating the reason for the deletion should be added, initialed,
and dated by the person who made the deletion. Pages should never be removed
from a laboratory notebook.
All data must be entered directly into the notebook, rather than on separate
papers for later copying into the notebook. When attaching forms, photographs,
charts, statistical printouts, etc., using glue or tape ensures permanence.
A mark or signature should be placed across any portion of the attachment and
lab notebook page. There must be no document replacement after the witness signs.
If there is blank space at the bottom of the page, lines drawn across the length
and width prevent additional comments or results from being added after the
page is witnessed. All transcribed data must be signed and dated by the individual
performing the transcription. The location of the raw data should also be included
if it is not in the notebook.
Control of Laboratory Notebooks
The document control department is responsible for the issuance, retrieval,
and maintenance of laboratory notebooks. However, during use, the assigned individual
assumes responsibility for the care and whereabouts of the book at all times.
The control of laboratory notebooks should be no different from other controlled
documents or quality records.
The laboratory notebook should be returned to the document control department
when completed or upon termination of its use. Before a laboratory notebook
is returned, appropriate personnel should review it to ensure that all items
were entered in accordance with procedure. The document control department should
note the return date in its log. All returned laboratory notebooks should be
filed in a centralized holding area in the department and should not leave the
area unless they are signed out. If a laboratory notebook is lost, the document
control department should be notified in writing, detailing the circumstances
surrounding the loss. This notice must be signed and dated by the employee and
his or her immediate supervisor.
Lastly, laboratory notebooks should be retained like any other controlled document.
Their retention should be specified in the company’s records retention
procedures.
Conclusion
Laboratory notebooks are an important component of a company’s quality
system and controlled documentation. The notebooks play an important role in
preserving and transferring valuable information and knowledge within a company.
An employee’s laboratory notebook is subject to inspection by colleagues,
supervisors, or outside regulatory body auditors. Thus, it is imperative that
GLP notebook practices are implemented and that a standardized procedure is
in place for handling laboratory notebooks. Laboratory notebooks must contain
all of the pertinent information required by the company. They must also be
maintained in a controlled manner. Defining these requirements ensures that
the contents of laboratory notebooks can withstand any challenges to their validity,
accuracy, or legibility.
Reference
1. FDA Compliance Program Guidance Manual, Program 7348.808, Chapter 28, “Bioresearch
Monitoring: Good Laboratory Practice (Nonclinical Laboratories),” February
21, 2001.
John A. DeLucia is vice president of regulatory affairs and quality assurance
at Smiths Medical ASD Inc. (Keene, NH).
Copyright ©2005 Medical Device & Diagnostic Industry
