DOCUMENTATION: THE

FOUNDATION OF QUALITY

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Lab Workers
Prepare Their
Documentation

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Documentation
Is Important!
Do what you say; say what you do.
If it isnt documented, it wasnt done.
Companies make two products, the one that
is sold and the documents that go with it.

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Function of Documentation

Ensure traceability
History and location of a product
The components of a product
Helps ensure that if problems arise, origin
of the problem can be traced to
components

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Traceability
Continued

Product can be found and recalled if

necessary
Legal and accountability issues arise often
many years after product was made
Traceability depends on an organized, welldesigned system of documentation

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Audit

FDA inspector comes to the facility!!!

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First thing they check is that all documentation

is present
That documentation is internally consistent
Documentation reflects what people really do
Auditors look closely at documentation

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Types Of
Documents:
Laboratory notebooks.
Standard Operating Procedures (SOPs)
Batch records
Equipment/Instrument logbooks
Electronic documents
Training logs

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More
Documents
Numbering systems
Labels
Chain of custody forms
Regulatory submissions
Release of final product record

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Example

Technician in a company prepares a 1 M

solution of NaCl:
1. The technician will follow an approved
standard operating procedure.

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2. The raw materials -- clean glassware,

NaCl, and purified water -- will all have
documents associated with them that
show they were tested and satisfactory.
3. The instruments used to weigh NaCl and
measure water have logbooks showing
they were properly maintained.

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4. The technician will record information

about the solution.
a) Preparers name
b) Date
c) Steps

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a) Quantities and
sources of raw
materials
b) Storage location
and conditions
c) Amounts of
components
d) ID number of
solution

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5. Solution will have an identifying number

and documentation associated with
assigning the number.
6. Solution will have a distinguishing label.

Labe
l
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Laboratory
Notebooks
Assigned to individuals.
Chronological log of everything that individual
does and observes.
Primary form of documentation in a research
laboratory.

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Legal document
Used to establish a patent claim
Assign credit for a discovery
Document the honesty and integrity of data
Trouble-shooting
Can be subpoenaed
Can be examined by regulatory agency

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A Lab Notebook
Is Not A Report

A laboratory notebook is not the same as a

report.
Lab notebook is chronological
1. May not be entirely neat
2. May have procedures materials mixed
with results

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Mistakes

Sometimes people record information on

separate sheets of paper
Forgot lab notebook
Want to keep the lab notebook neat and
orderly
DONT!!

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Annotated
Lab Notebook
Page

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SOPs Are
Very Important
Phrase often repeated in GMP: there shall
be procedures for
This means that by law, companies that are
compliant with GMP must have SOPs
SOPs are documents that spell out how to do
something, procedures

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Production facilities and many laboratories use

documents SOPS
Instruct personnel in how to perform particular tasks.
Step-by step outline of how a task is to be performed.
Indicate in which situations the task is done
Who is qualified or responsible for the work
Etc.

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Since everyone follows the same SOPs,

they help ensure that work is performed
correctly and consistently over time.

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Some Types
Of SOPs

Administrative SOPs
Such as how to assign lab notebooks
Processes
Such as how to investigate problem
Tasks
Such as how to operate a balance

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Writing SOPs

What is the purpose of the procedure? What

will be the outcome or product of the
procedure?
What resources and materials will the person
performing the SOP require in order to
achieve the desired result?

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Batch Records

Document that accompanies product as it is

made
Directs operators in how to make product
Provides blanks that are filled in as product is
made
For critical steps, witness watches and signs

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Moral Of
The Story
Keep good records, wherever you work
Dont obscure problems or mistakes
Dating is critical, keep records chronological,
that is, in order by date

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