Regulatory Writing: An Overview 18
and expectations while avoiding conflicting or
inconsistent information.
A lack of specificity and detail can result in
unanticipated vulnerabilities by inviting subjective
interpretations. Achieving consistency involves care-
fully defining the terms used, abbreviations employed,
and unifying individual writing styles. Also, focusing
on the documentation’s goal and understanding the
targeted audience should be taken into consideration.
Clearly delineate processes and relationships.
Writing style and language use also are import-
ant in maintaining consistency and clarity. The
following questions apply:
• Is the terminology used consistently
throughout the documentation system?
• Does the language cater to the intended
reader’s level?
• Is the document easy to read and follow?
• Do the processes and/or procedures iden-
tified lead the user to the desired result
efficiently?
• Is the document’s information compliant
with regulatory expectations?
• Will the document’s contents and relevance
be easy to explain during the inspection?
• Is the information included in the doc-
ument all relevant to the subject matter
under discussion?
Organizations should create document inven-
tory lists, so they are readily available to users and
regulators upon request. An electronically based
documentation system should include copies of his-
toric documents and a robust change control process.
Connecting the documentation and any changes
to it with the training program would be optimal.
The more coordinated these good documentation
system elements are, the smoother the transition
between product development phases and across
different functional groups. The consistent capture of
specifications, procedures, records, and data, and this
information’s accessibility are key to successful oper-
ations and a healthy regulatory compliance profile.
Completeness matters. When filling out forms
or documenting results, each required element should
be addressed and every blank filled with either the
appropriate answer or, if not applicable, N/A. During
inspections, the agency will not assume a blank space
means a requirement was N/A it will presume the
requirement was overlooked. During pre-inspections,
any use of “not applicable” should be scrutinized
carefully and blank spaces eliminated.
Transparency and Disclosure
A culture of honesty and openness is an essen-
tial component of GDPs and achieving a healthy
compliance profile. In addition to an organization’s
willingness to communicate, that can open the door
to more efficient product review processes, audits,
inspections, and compliance dispute resolution
efforts. FDA emphasizes the importance of data
integrity during inspections, particularly current
Good Manufacturing Practice (CGMP) inspections.1
An organization must consider and make
decisions carefully about what content should be
captured in which documentation. For example, it is
inadvisable to address overall product development
strategy in a protocol or Investigator’s Brochure,
even though this information is included in an IND
or background package. Internal planning and clear
upper management direction are necessary, so an
organization’s documents remain meaningful, rele-
vant, and applicable to its actual operations.
Identifying Documentation
Guidelines and Resources
The ICH has been instrumental in the global
initiative to standardize pharmaceutical product
development and regulation. In realizing its vision,
ICH has taken the lead on preventing duplication
of efforts, reducing product development timelines,
streamlining product approvals, and contributing to
human health protection.
One of ICH’s most important initiatives
has been the creation and implementation of the
Common Technical Document (CTD) for the
assembly of all the quality, safety, and efficacy
information for regulatory reviews in each member
region. By consolidating the documentation nec-
essary for a product to be adequately reviewed and
approved efficiently, regulatory authorities, industry
sponsors, and the public have benefitted.
Elements of the requirements of Good Clinical
Practice (GCP), GMP, and Good Laboratory
Practice (GLP) can be utilized when putting an
effective GDP system into place. The following are
some available resources:
and expectations while avoiding conflicting or
inconsistent information.
A lack of specificity and detail can result in
unanticipated vulnerabilities by inviting subjective
interpretations. Achieving consistency involves care-
fully defining the terms used, abbreviations employed,
and unifying individual writing styles. Also, focusing
on the documentation’s goal and understanding the
targeted audience should be taken into consideration.
Clearly delineate processes and relationships.
Writing style and language use also are import-
ant in maintaining consistency and clarity. The
following questions apply:
• Is the terminology used consistently
throughout the documentation system?
• Does the language cater to the intended
reader’s level?
• Is the document easy to read and follow?
• Do the processes and/or procedures iden-
tified lead the user to the desired result
efficiently?
• Is the document’s information compliant
with regulatory expectations?
• Will the document’s contents and relevance
be easy to explain during the inspection?
• Is the information included in the doc-
ument all relevant to the subject matter
under discussion?
Organizations should create document inven-
tory lists, so they are readily available to users and
regulators upon request. An electronically based
documentation system should include copies of his-
toric documents and a robust change control process.
Connecting the documentation and any changes
to it with the training program would be optimal.
The more coordinated these good documentation
system elements are, the smoother the transition
between product development phases and across
different functional groups. The consistent capture of
specifications, procedures, records, and data, and this
information’s accessibility are key to successful oper-
ations and a healthy regulatory compliance profile.
Completeness matters. When filling out forms
or documenting results, each required element should
be addressed and every blank filled with either the
appropriate answer or, if not applicable, N/A. During
inspections, the agency will not assume a blank space
means a requirement was N/A it will presume the
requirement was overlooked. During pre-inspections,
any use of “not applicable” should be scrutinized
carefully and blank spaces eliminated.
Transparency and Disclosure
A culture of honesty and openness is an essen-
tial component of GDPs and achieving a healthy
compliance profile. In addition to an organization’s
willingness to communicate, that can open the door
to more efficient product review processes, audits,
inspections, and compliance dispute resolution
efforts. FDA emphasizes the importance of data
integrity during inspections, particularly current
Good Manufacturing Practice (CGMP) inspections.1
An organization must consider and make
decisions carefully about what content should be
captured in which documentation. For example, it is
inadvisable to address overall product development
strategy in a protocol or Investigator’s Brochure,
even though this information is included in an IND
or background package. Internal planning and clear
upper management direction are necessary, so an
organization’s documents remain meaningful, rele-
vant, and applicable to its actual operations.
Identifying Documentation
Guidelines and Resources
The ICH has been instrumental in the global
initiative to standardize pharmaceutical product
development and regulation. In realizing its vision,
ICH has taken the lead on preventing duplication
of efforts, reducing product development timelines,
streamlining product approvals, and contributing to
human health protection.
One of ICH’s most important initiatives
has been the creation and implementation of the
Common Technical Document (CTD) for the
assembly of all the quality, safety, and efficacy
information for regulatory reviews in each member
region. By consolidating the documentation nec-
essary for a product to be adequately reviewed and
approved efficiently, regulatory authorities, industry
sponsors, and the public have benefitted.
Elements of the requirements of Good Clinical
Practice (GCP), GMP, and Good Laboratory
Practice (GLP) can be utilized when putting an
effective GDP system into place. The following are
some available resources: