15 Chapter 2: Good Documentation Practices
Overview of Good Documentation
Practices
Documentation is often the first and sometimes the
only impression a regulator receives of a research
group or organization. A robust documentation sys-
tem serves as the foundation from which a healthy
compliance program can be built and, once in place,
will remain a source of first impressions during
audits and inspections. The documents themselves,
individually and collectively, represent the face of a
company’s operations.
Good Documentation Practices (GDPs) are
essential in any professional setting and critical in
regulated medical device, drug, and biological product
environments. In general, GDPs include all written
activities, processes, studies, and results associated
with product development, approval, maintenance,
and improvement. Good documentation serves as
evidence of product development decisions and
provides a basis for all activities required throughout
the product’s lifetime. Given the dynamics of product
development and the time it may take to realize com-
mercialization, good documentation allows consistent
information transfer among parties, functional groups,
and health authorities.
A sound documentation system also allows
regulatory agencies to conduct a complete and
efficient review of marketing applications and other
communications necessary for product evaluation
and approval. GDPs help regulators understand
the product’s history, assess the adequacy of studies,
verify data integrity, and assess the appropriateness
of intended use and the validity of claims about the
product’s safety, efficacy, and quality.
While critically important to ensure the safety
of approved products, GDP compliance throughout
product development should be applied from the
product’s conception. From prototype through clin-
ical trials and up to postmarket surveillance, GDPs
should be developed, implemented, and maintained.
GDPs apply to:
• Procedures (e.g., standard operating proce-
dures (SOPs))
• Documentation during product develop-
ment (e.g., Drug Master Files or Device
Master Files)
• Documentation for purposes of product
clearances, approvals, and licenses (e.g.,
510(k)s, Premarket Approval applications
(PMAs), New Drug Applications (NDAs),
and Biologics License Applications
(BLAs))
• Pharmacovigilance and medical device
reporting documentation
• Assembly of justification files to support an
organization’s decision-making process and
conclusions reached
• Postmarketing documentation
2
Good Documentation Practices
By Jenny Grodberg, PhD, RAC, Jocelyn Jennings, MS, RAC, and Joanne
Rupprecht, Esq, RAC
Overview of Good Documentation
Practices
Documentation is often the first and sometimes the
only impression a regulator receives of a research
group or organization. A robust documentation sys-
tem serves as the foundation from which a healthy
compliance program can be built and, once in place,
will remain a source of first impressions during
audits and inspections. The documents themselves,
individually and collectively, represent the face of a
company’s operations.
Good Documentation Practices (GDPs) are
essential in any professional setting and critical in
regulated medical device, drug, and biological product
environments. In general, GDPs include all written
activities, processes, studies, and results associated
with product development, approval, maintenance,
and improvement. Good documentation serves as
evidence of product development decisions and
provides a basis for all activities required throughout
the product’s lifetime. Given the dynamics of product
development and the time it may take to realize com-
mercialization, good documentation allows consistent
information transfer among parties, functional groups,
and health authorities.
A sound documentation system also allows
regulatory agencies to conduct a complete and
efficient review of marketing applications and other
communications necessary for product evaluation
and approval. GDPs help regulators understand
the product’s history, assess the adequacy of studies,
verify data integrity, and assess the appropriateness
of intended use and the validity of claims about the
product’s safety, efficacy, and quality.
While critically important to ensure the safety
of approved products, GDP compliance throughout
product development should be applied from the
product’s conception. From prototype through clin-
ical trials and up to postmarket surveillance, GDPs
should be developed, implemented, and maintained.
GDPs apply to:
• Procedures (e.g., standard operating proce-
dures (SOPs))
• Documentation during product develop-
ment (e.g., Drug Master Files or Device
Master Files)
• Documentation for purposes of product
clearances, approvals, and licenses (e.g.,
510(k)s, Premarket Approval applications
(PMAs), New Drug Applications (NDAs),
and Biologics License Applications
(BLAs))
• Pharmacovigilance and medical device
reporting documentation
• Assembly of justification files to support an
organization’s decision-making process and
conclusions reached
• Postmarketing documentation
2
Good Documentation Practices
By Jenny Grodberg, PhD, RAC, Jocelyn Jennings, MS, RAC, and Joanne
Rupprecht, Esq, RAC