17 Chapter 2: Good Documentation Practices
o If current operations do not allow
for compliance with stated require-
ments, do not document them as
requirements.
• Implement robust change control pro-
cedures to capture all changes made to
documentation and review periodically:
o Corrections to hand-written documen-
tation should be made with a single
line, signed and dated.
o White out should never be used for
corrections. (ICH GCP 4.9.3)
o The reason(s) for any documentation
corrections or changes should be
stated.
• Remain current on quality and regulatory
rules and regulations, and update documen-
tation as needed:
o Document compliance clearly and
reference supporting guidelines and
resources used.
o If applicable, justification for any
necessary noncompliance resulting
from business decisions or changes in
rules, regulations, or policies should be
documented.
• Write clearly, using consistent practices and
language:
o Stick to technical writing basics this is
not creative writing.
o Use established words, references, and
acronyms.
o Avoid discrepancies within and
between documents. While many
groups may contribute to a document,
finalization should be centralized
within the quality, regulatory, medical
writing, and labeling group.
o Adopt an appropriate style for each
document. Bench science, manufac-
turing, and regulatory affairs writing
styles differ and should be used as
appropriate.
o Avoid the use of arrows and “ditto”
marks.
• Maintain control of contents and records:
o Documentation should be attributable,
legible, contemporaneous, original, and
accurate (ALCOA).
o Verify what is documented to the
extent practicable.
o In the event of an audit or inspection,
the information trail should be clear
and complete where it may lead, or
where it may fail to lead, should be
anticipated and defensible.
o Do not destroy records keep them as
accessible as possible for internal use
while protecting them from public
access.
Documenting Procedures
When creating documentation, the questions of
what, when, why, and how should be addressed and
a format created to memorialize the outcome of
documented processes or procedures. With increas-
ing emphasis being put on Quality Management
Systems (QMS) and risk management during
agency inspections and audits, an organization must
pay careful attention to its SOP documentation.
Procedures established to maintain quality oper-
ations are of little value if not followed, and when
such documentation is not followed, it creates a trail
of noncompliance. Any deficiency in adhering to the
specifications, procedures, or recordkeeping require-
ments impacts an organization’s compliance profile.
One must adhere to SOPs, validated specifications,
or other work instructions referenced within the
system. The documents containing validated product
specifications are most important since any deviation
could compromise product quality and potentially
pose a danger to consumers. If an organization has
no intention of adhering to SOPs, it may be better
not to have them.
Consistency, Clarity, Completeness
A primary goal of GDP is to avoid conflicting
provisions, ambiguous statements, incompatible
requirements, and unattainable compliance goals.
Consistency is important among related documents,
regulatory requirements, and agency documents so
that readers can find needed information.
A documentation system often involves many
cross-functional groups, sometimes with overlapping
areas of responsibility. Hence, an organization may
develop documents with similar business goals but
diverging execution pathways. Internal communica-
tion is key when documenting roles, responsibilities,
o If current operations do not allow
for compliance with stated require-
ments, do not document them as
requirements.
• Implement robust change control pro-
cedures to capture all changes made to
documentation and review periodically:
o Corrections to hand-written documen-
tation should be made with a single
line, signed and dated.
o White out should never be used for
corrections. (ICH GCP 4.9.3)
o The reason(s) for any documentation
corrections or changes should be
stated.
• Remain current on quality and regulatory
rules and regulations, and update documen-
tation as needed:
o Document compliance clearly and
reference supporting guidelines and
resources used.
o If applicable, justification for any
necessary noncompliance resulting
from business decisions or changes in
rules, regulations, or policies should be
documented.
• Write clearly, using consistent practices and
language:
o Stick to technical writing basics this is
not creative writing.
o Use established words, references, and
acronyms.
o Avoid discrepancies within and
between documents. While many
groups may contribute to a document,
finalization should be centralized
within the quality, regulatory, medical
writing, and labeling group.
o Adopt an appropriate style for each
document. Bench science, manufac-
turing, and regulatory affairs writing
styles differ and should be used as
appropriate.
o Avoid the use of arrows and “ditto”
marks.
• Maintain control of contents and records:
o Documentation should be attributable,
legible, contemporaneous, original, and
accurate (ALCOA).
o Verify what is documented to the
extent practicable.
o In the event of an audit or inspection,
the information trail should be clear
and complete where it may lead, or
where it may fail to lead, should be
anticipated and defensible.
o Do not destroy records keep them as
accessible as possible for internal use
while protecting them from public
access.
Documenting Procedures
When creating documentation, the questions of
what, when, why, and how should be addressed and
a format created to memorialize the outcome of
documented processes or procedures. With increas-
ing emphasis being put on Quality Management
Systems (QMS) and risk management during
agency inspections and audits, an organization must
pay careful attention to its SOP documentation.
Procedures established to maintain quality oper-
ations are of little value if not followed, and when
such documentation is not followed, it creates a trail
of noncompliance. Any deficiency in adhering to the
specifications, procedures, or recordkeeping require-
ments impacts an organization’s compliance profile.
One must adhere to SOPs, validated specifications,
or other work instructions referenced within the
system. The documents containing validated product
specifications are most important since any deviation
could compromise product quality and potentially
pose a danger to consumers. If an organization has
no intention of adhering to SOPs, it may be better
not to have them.
Consistency, Clarity, Completeness
A primary goal of GDP is to avoid conflicting
provisions, ambiguous statements, incompatible
requirements, and unattainable compliance goals.
Consistency is important among related documents,
regulatory requirements, and agency documents so
that readers can find needed information.
A documentation system often involves many
cross-functional groups, sometimes with overlapping
areas of responsibility. Hence, an organization may
develop documents with similar business goals but
diverging execution pathways. Internal communica-
tion is key when documenting roles, responsibilities,