3 Regulatory Affairs Professionals Society
Introduction
Documentation is often a regulator’s first, and sometimes
only, impression of a research group or organization. A robust
documentation system 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), essential in any
professional setting, are critical in regulated medical device,
drug, and biological product environments. In general, GDPs
encompass 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 potential time-
line for realizing commercialization, good documentation
allows consistent information transfer among parties, func-
tional groups, and regulatory authorities. Some organizations
refer to GDPs to encompass Good Recordkeeping Practice,
an essential component of overall Pharmaceutical Quality
Systems (PQS) and Quality Risk Management strategies
(QRM).
A sound documentation system also allows regula-
tory 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.
Ensuring the safety of approved products is critically
important GDP compliance should be applied from the
product’s conception and throughout its development.
From prototype through clinical trials and up to postmarket
surveillance, GDPs should be developed, implemented, and
maintained.
GDPs apply to the following:
• Procedures (e.g., standard operating procedures [SOPs])
• Documentation during product development (e.g., for-
mulation development reports, drug master files, device
master files or design history files)
• Documentation for purposes of product clearances,
approvals, and licenses (e.g., premarket notification
[510(k)s], premarket approval applications, new drug
applications, and biologics license applications)
• Pharmacovigilance and medical device reporting
documentation
• Assembly of justification files to support an organiza-
tion’s decision-making process and conclusions reached
• Regulatory authority meeting packages and meeting
minutes
• Regulatory interaction correspondence
• Postmarket documentation
Regulatory authorities can provide a GDP framework that is
incomplete. 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 issued by the
US Food and Drug Administration (FDA), the European
Medicines Agency (EMA), or other regulatory authorities do
not establish legally enforceable responsibilities. Their influ-
ence is limited to a regulatory authority’s current thinking on
a topic and their recommendations should be applied when
possible and supplemented with existing available statutory
requirements. An organization should consult the expecta-
tions of all applicable regulatory authorities, the International
Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH), the International
Medical Device Regulators Forum (IMDRF), and the World
Health Organization (WHO).
Being well-versed in regulations is merely the first step
in creating a healthy compliance profile, producing docu-
mentation, maintaining a robust quality system, and meeting
1 Good Documentation Practices
Jenny Grodberg, PhD, RAC-US Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices, FRAPS
Introduction
Documentation is often a regulator’s first, and sometimes
only, impression of a research group or organization. A robust
documentation system 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), essential in any
professional setting, are critical in regulated medical device,
drug, and biological product environments. In general, GDPs
encompass 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 potential time-
line for realizing commercialization, good documentation
allows consistent information transfer among parties, func-
tional groups, and regulatory authorities. Some organizations
refer to GDPs to encompass Good Recordkeeping Practice,
an essential component of overall Pharmaceutical Quality
Systems (PQS) and Quality Risk Management strategies
(QRM).
A sound documentation system also allows regula-
tory 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.
Ensuring the safety of approved products is critically
important GDP compliance should be applied from the
product’s conception and throughout its development.
From prototype through clinical trials and up to postmarket
surveillance, GDPs should be developed, implemented, and
maintained.
GDPs apply to the following:
• Procedures (e.g., standard operating procedures [SOPs])
• Documentation during product development (e.g., for-
mulation development reports, drug master files, device
master files or design history files)
• Documentation for purposes of product clearances,
approvals, and licenses (e.g., premarket notification
[510(k)s], premarket approval applications, new drug
applications, and biologics license applications)
• Pharmacovigilance and medical device reporting
documentation
• Assembly of justification files to support an organiza-
tion’s decision-making process and conclusions reached
• Regulatory authority meeting packages and meeting
minutes
• Regulatory interaction correspondence
• Postmarket documentation
Regulatory authorities can provide a GDP framework that is
incomplete. 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 issued by the
US Food and Drug Administration (FDA), the European
Medicines Agency (EMA), or other regulatory authorities do
not establish legally enforceable responsibilities. Their influ-
ence is limited to a regulatory authority’s current thinking on
a topic and their recommendations should be applied when
possible and supplemented with existing available statutory
requirements. An organization should consult the expecta-
tions of all applicable regulatory authorities, the International
Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH), the International
Medical Device Regulators Forum (IMDRF), and the World
Health Organization (WHO).
Being well-versed in regulations is merely the first step
in creating a healthy compliance profile, producing docu-
mentation, maintaining a robust quality system, and meeting
1 Good Documentation Practices
Jenny Grodberg, PhD, RAC-US Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices, FRAPS