Regulatory Writing: An Overview 16
Regulatory bodies do not provide a complete GDP
framework. Most guidance documents and defined
regulatory standards contain GDP elements, and each
stage of product development has its nuances as to
how documentation should be approached. Although
guidance documents do not establish legally enforce-
able responsibilities, and their influence is limited to
a health authority’s current thinking on a topic, their
recommendations should be applied when possible
and supplemented with existing available statutory
requirements. An organization should consult the
expectations of all applicable regulatory authori-
ties, the International Council for Harmonisation
of Technical Requirements for Pharmaceuticals
for Human Use (ICH), and the World Health
Organization (WHO).
Being well-versed in regulations is only the
first step in creating a healthy compliance profile,
producing documentation, maintaining a robust
quality system, and meeting regulatory requirements.
Much emphasis on GDP adherence is placed on
postmarket documentation, such as medical infor-
mation communications, promotional materials, and
user operation manuals. These documents should not
stray from the approved indications or safety and
efficacy claims. Supporting documentation should
be kept on file.
This chapter explores the components of GDPs.
While this discussion is not exhaustive, the best efforts
have been made to provide a thorough understanding
of the principles and concepts necessary to develop,
maintain, or improve an existing documentation
system. Health authority expectations and industry
best practices will continue to evolve, which under-
scores the importance of regularly monitoring internal
systems and implementing value-added changes.
Goals of Documentation
It is best to start organizing documentation with the
end purpose in mind. Documentation is essential
for effective and efficient operations and serves the
following purposes:
• Making internal processes and procedures
clear and consistent
• Assisting in personnel training and
cross-training
• Creating a reference for conducting
evaluations
• Creating standards upon which continual
improvements can be built
• Tracking product changes and the reason-
ing behind them
o Centralizing important concepts
related to business development
o Creating a foundation for risk
assessments and quality systems’
maintenance
o Incorporating global regulatory con-
siderations, as necessary
o Allowing internal and external product
knowledge transfer
• Complying with quality and regulatory
expectations
• Supporting product approval applications
• Assisting in putting the product into and
maintaining it in commercial distribution
An organization must understand its documenta-
tion system’s goals, define its components, review
its requirements, implement its execution, train for
incorporating it into organizational culture, and
maintain it and its results periodically.
Basic Principles of GDPs
When developing GDPs:
• Look at the consequences of including or
omitting information:
o If information is not documented, it
does not exist retrospective documen-
tation is not recommended.
o Overkill in reporting minor details or
repeating information may impede
transparency.
o Templates are a good start, but cus-
tomization is crucial and should be
specific to each organization and each
internal group within an organization.
o Do not make reviewers look too hard
to verify the organization’s compliance.
• Make required actions and expectations
attainable:
o Avoid requiring actions that existing
personnel cannot support.
o Budgetary constraints may exist that
limit implementation of the ideal
system.
Regulatory bodies do not provide a complete GDP
framework. Most guidance documents and defined
regulatory standards contain GDP elements, and each
stage of product development has its nuances as to
how documentation should be approached. Although
guidance documents do not establish legally enforce-
able responsibilities, and their influence is limited to
a health authority’s current thinking on a topic, their
recommendations should be applied when possible
and supplemented with existing available statutory
requirements. An organization should consult the
expectations of all applicable regulatory authori-
ties, the International Council for Harmonisation
of Technical Requirements for Pharmaceuticals
for Human Use (ICH), and the World Health
Organization (WHO).
Being well-versed in regulations is only the
first step in creating a healthy compliance profile,
producing documentation, maintaining a robust
quality system, and meeting regulatory requirements.
Much emphasis on GDP adherence is placed on
postmarket documentation, such as medical infor-
mation communications, promotional materials, and
user operation manuals. These documents should not
stray from the approved indications or safety and
efficacy claims. Supporting documentation should
be kept on file.
This chapter explores the components of GDPs.
While this discussion is not exhaustive, the best efforts
have been made to provide a thorough understanding
of the principles and concepts necessary to develop,
maintain, or improve an existing documentation
system. Health authority expectations and industry
best practices will continue to evolve, which under-
scores the importance of regularly monitoring internal
systems and implementing value-added changes.
Goals of Documentation
It is best to start organizing documentation with the
end purpose in mind. Documentation is essential
for effective and efficient operations and serves the
following purposes:
• Making internal processes and procedures
clear and consistent
• Assisting in personnel training and
cross-training
• Creating a reference for conducting
evaluations
• Creating standards upon which continual
improvements can be built
• Tracking product changes and the reason-
ing behind them
o Centralizing important concepts
related to business development
o Creating a foundation for risk
assessments and quality systems’
maintenance
o Incorporating global regulatory con-
siderations, as necessary
o Allowing internal and external product
knowledge transfer
• Complying with quality and regulatory
expectations
• Supporting product approval applications
• Assisting in putting the product into and
maintaining it in commercial distribution
An organization must understand its documenta-
tion system’s goals, define its components, review
its requirements, implement its execution, train for
incorporating it into organizational culture, and
maintain it and its results periodically.
Basic Principles of GDPs
When developing GDPs:
• Look at the consequences of including or
omitting information:
o If information is not documented, it
does not exist retrospective documen-
tation is not recommended.
o Overkill in reporting minor details or
repeating information may impede
transparency.
o Templates are a good start, but cus-
tomization is crucial and should be
specific to each organization and each
internal group within an organization.
o Do not make reviewers look too hard
to verify the organization’s compliance.
• Make required actions and expectations
attainable:
o Avoid requiring actions that existing
personnel cannot support.
o Budgetary constraints may exist that
limit implementation of the ideal
system.