Chapter 1: Good Documentation Practices
4 Regulatory Affairs Professionals Society
regulatory requirements. GDP adherence is highly focused
on postmarket documentation, such as medical information
communications, promotional materials, and user opera-
tion 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.
Although not exhaustive, the discussion highlights the best
efforts to provide a thorough understanding of the princi-
ples and concepts necessary to develop, maintain, or improve
an existing documentation system. The fact that regula-
tory authority expectations and industry best practices will
continue to evolve underscores 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 fostered
• Tracking product changes and the reasoning 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 considerations, as
necessary
o Allowing internal and external product knowledge
transfer
o Complying with quality and regulatory expectations
o Supporting premarket applications
o Supporting postmarket commitment requirements and
surveillance activities
o Assisting in putting the product into and maintaining it
in commercial distribution
An organization must understand its documentation sys-
tem’s goals, define its components, review its requirements,
implement its execution, train for incorporating it into orga-
nizational culture, and maintain it and its results periodically.
Basic Principles of GDPs
When developing GDPs, it is important to:
• Look at the consequences of including or omitting infor-
mation:
o If information is not documented, it does not exist retro-
spective documentation is not recommended.
o Overkill in reporting minor details or repeating informa-
tion may impede transparency.
o Templates are a good start, but customization is crucial
and should be specific to each organization and internal
group within an organization.
o Do not make reviewers look too hard to verify the orga-
nization’s compliance.
• Make required actions and expectations attainable:
o Avoid requiring actions that existing personnel cannot
support.
o Budgetary constraints may exist that limit implementa-
tion of the ideal system.
o If current operations do not allow for compliance
with stated requirements, do not document them as
requirements.
• Implement robust change control procedures to cap-
ture all changes made to documentation and review
periodically:
o Corrections to hand-written documentation should be
made with a single line, signed and dated.
o White-out should never be used for corrections.
o The reason(s) for any documentation corrections or
changes should be stated.
• Remain current on quality and regulatory rules and regu-
lations, and update documentation as needed:
o Document compliance clearly and reference supporting
guidelines and resources used.
o If applicable, justification for any necessary noncom-
pliance 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. Define
acronyms on first usage in a document.
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, or labeling group.
o Adopt an appropriate style for each document. Bench
science, manufacturing, 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, con-
temporaneous, original, and accurate (ALCOA). (ICH
E6(R3) Section 2.12.2)1
o Verify what is documented to the extent practicable.
o In the event of an audit or inspection, the audit 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 pos-
sible for internal use while protecting them from public
access.
o Ensure data Integrity with validated, protected, secure
and backed-up data systems.
4 Regulatory Affairs Professionals Society
regulatory requirements. GDP adherence is highly focused
on postmarket documentation, such as medical information
communications, promotional materials, and user opera-
tion 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.
Although not exhaustive, the discussion highlights the best
efforts to provide a thorough understanding of the princi-
ples and concepts necessary to develop, maintain, or improve
an existing documentation system. The fact that regula-
tory authority expectations and industry best practices will
continue to evolve underscores 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 fostered
• Tracking product changes and the reasoning 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 considerations, as
necessary
o Allowing internal and external product knowledge
transfer
o Complying with quality and regulatory expectations
o Supporting premarket applications
o Supporting postmarket commitment requirements and
surveillance activities
o Assisting in putting the product into and maintaining it
in commercial distribution
An organization must understand its documentation sys-
tem’s goals, define its components, review its requirements,
implement its execution, train for incorporating it into orga-
nizational culture, and maintain it and its results periodically.
Basic Principles of GDPs
When developing GDPs, it is important to:
• Look at the consequences of including or omitting infor-
mation:
o If information is not documented, it does not exist retro-
spective documentation is not recommended.
o Overkill in reporting minor details or repeating informa-
tion may impede transparency.
o Templates are a good start, but customization is crucial
and should be specific to each organization and internal
group within an organization.
o Do not make reviewers look too hard to verify the orga-
nization’s compliance.
• Make required actions and expectations attainable:
o Avoid requiring actions that existing personnel cannot
support.
o Budgetary constraints may exist that limit implementa-
tion of the ideal system.
o If current operations do not allow for compliance
with stated requirements, do not document them as
requirements.
• Implement robust change control procedures to cap-
ture all changes made to documentation and review
periodically:
o Corrections to hand-written documentation should be
made with a single line, signed and dated.
o White-out should never be used for corrections.
o The reason(s) for any documentation corrections or
changes should be stated.
• Remain current on quality and regulatory rules and regu-
lations, and update documentation as needed:
o Document compliance clearly and reference supporting
guidelines and resources used.
o If applicable, justification for any necessary noncom-
pliance 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. Define
acronyms on first usage in a document.
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, or labeling group.
o Adopt an appropriate style for each document. Bench
science, manufacturing, 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, con-
temporaneous, original, and accurate (ALCOA). (ICH
E6(R3) Section 2.12.2)1
o Verify what is documented to the extent practicable.
o In the event of an audit or inspection, the audit 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 pos-
sible for internal use while protecting them from public
access.
o Ensure data Integrity with validated, protected, secure
and backed-up data systems.