Regulatory Writing: An Overview
Third Edition
5 Regulatory Affairs Professionals Society
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 increasing emphasis being put on quality
management systems and risk management during agency
inspections and audits, an organization must pay careful
attention to its SOP documentation. Procedures estab-
lished to maintain quality operations 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, other controlled
documents as well as work instructions or study plans (when
applicable) referenced within the system. The documents con-
taining validated product specifications are most important
since any deviation could compromise product quality and
potentially pose a danger to consumers.
Consistency, Clarity, and 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 docu-
ments with similar business goals but diverging execution
pathways. Internal communication is key when documenting
roles, responsibilities, and expectations while avoiding con-
flicting or inconsistent information.
A lack of specificity and detail can result in unantici-
pated vulnerabilities by inviting subjective interpretations.
Achieving consistency involves carefully defining the terms
used, abbreviations employed, and unifying individual writing
styles. A focus on the documentation’s goal and understand-
ing the targeted audience is also important.
Clearly Delineate Processes and Relationships. Writing style
and language use also are important in maintaining consis-
tency 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 identified 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 an inspection?
• Is the information included in the document all relevant
to the subject matter under discussion?
Organizations should create document inventory lists, so they
are readily available to users and regulators upon request. An
electronically based documentation system should include
copies of historic 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 operations
and a healthy regulatory compliance profile.
Completeness matters. When filling out forms or docu-
menting 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-inspec-
tions, any use of not applicable are scrutinized carefully and
blank spaces eliminated.
Transparency and Disclosure
A culture of honesty and openness is an essential compo-
nent of GDPs and achieving a healthy compliance profile.
In addition to an organization’s willingness to communicate,
such a culture can open the door to more efficient product
review processes, audits, inspections, and compliance dispute
resolution efforts. The FDA emphasizes the importance of
data integrity during inspections, particularly current Good
Manufacturing Practice inspections.2
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 Investigational New Drug application or
background package. Internal planning and clear upper
management direction are necessary, so an organization’s
documents remain meaningful, relevant, and applicable to its
actual operations.
Identifying Documentation Guidelines and
Resources
Although no single regulation or policy defines GDP, its
components are cited by federal and international agencies,
including FDA, ICH, IMDRF, and WHO, as well as insti-
tutional policy. Professional groups, such as Pharmaceutical
Research and Manufacturers of America (PhRMA) and
TransCelerate, also collaborate with industry partners to
provide guidance that, such as the ICH guidelines, help
bridge content development and ethical concerns with
requirements for reporting and other types of documentation.
Additionally, country-, region-, and therapeutic area-specific
guidelines exist for many different purposes. For example,
guidance such as the PhRMA Code,3 the Standard Protocol
Items: Recommendations for Interventional Trials (SPIRIT)
Checklist,4 and various works on the Enhancing the Quality
Third Edition
5 Regulatory Affairs Professionals Society
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 increasing emphasis being put on quality
management systems and risk management during agency
inspections and audits, an organization must pay careful
attention to its SOP documentation. Procedures estab-
lished to maintain quality operations 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, other controlled
documents as well as work instructions or study plans (when
applicable) referenced within the system. The documents con-
taining validated product specifications are most important
since any deviation could compromise product quality and
potentially pose a danger to consumers.
Consistency, Clarity, and 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 docu-
ments with similar business goals but diverging execution
pathways. Internal communication is key when documenting
roles, responsibilities, and expectations while avoiding con-
flicting or inconsistent information.
A lack of specificity and detail can result in unantici-
pated vulnerabilities by inviting subjective interpretations.
Achieving consistency involves carefully defining the terms
used, abbreviations employed, and unifying individual writing
styles. A focus on the documentation’s goal and understand-
ing the targeted audience is also important.
Clearly Delineate Processes and Relationships. Writing style
and language use also are important in maintaining consis-
tency 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 identified 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 an inspection?
• Is the information included in the document all relevant
to the subject matter under discussion?
Organizations should create document inventory lists, so they
are readily available to users and regulators upon request. An
electronically based documentation system should include
copies of historic 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 operations
and a healthy regulatory compliance profile.
Completeness matters. When filling out forms or docu-
menting 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-inspec-
tions, any use of not applicable are scrutinized carefully and
blank spaces eliminated.
Transparency and Disclosure
A culture of honesty and openness is an essential compo-
nent of GDPs and achieving a healthy compliance profile.
In addition to an organization’s willingness to communicate,
such a culture can open the door to more efficient product
review processes, audits, inspections, and compliance dispute
resolution efforts. The FDA emphasizes the importance of
data integrity during inspections, particularly current Good
Manufacturing Practice inspections.2
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 Investigational New Drug application or
background package. Internal planning and clear upper
management direction are necessary, so an organization’s
documents remain meaningful, relevant, and applicable to its
actual operations.
Identifying Documentation Guidelines and
Resources
Although no single regulation or policy defines GDP, its
components are cited by federal and international agencies,
including FDA, ICH, IMDRF, and WHO, as well as insti-
tutional policy. Professional groups, such as Pharmaceutical
Research and Manufacturers of America (PhRMA) and
TransCelerate, also collaborate with industry partners to
provide guidance that, such as the ICH guidelines, help
bridge content development and ethical concerns with
requirements for reporting and other types of documentation.
Additionally, country-, region-, and therapeutic area-specific
guidelines exist for many different purposes. For example,
guidance such as the PhRMA Code,3 the Standard Protocol
Items: Recommendations for Interventional Trials (SPIRIT)
Checklist,4 and various works on the Enhancing the Quality