21 Chapter 2: Good Documentation Practices
Building a Robust GDP System
Consider all Applicable Documentation
The following are some documents that should be
considered in regulated healthcare environments:
• Research and development
o Conception plans
o Prototype designs
o Specification requirements
o Clinical study protocols
o Investigator’s Brochures
o Investigational Review Board (IRB)
and investigator communications
o Informed consent forms
o Case Report Forms (CRFs)
o Investigator clinical study reports
• Sponsor narratives
• Commercialization
o FDA presubmission communications
o Supportive documentation for regula-
tory submissions
o Manufacturing standard operating
procedures (SOPs)
o Validation and stability reports
o Batch records
o COAs
o Labeling justifications and finalization
o Regulatory submissions
• Postmarket
o Market and launch documentation
o Proof of compliance with acceptable
practices and ISO requirements
o Pharmacovigilance reports
o Periodic safety updates
o Medical information communications
o Annual reports
o Supplemental filings
o Benefit-risk evaluation reports
o Serious adverse reaction reports
o Postmarket study requirements
o Advertising and promotional materials
and references
Good Practices for Signatures, Change Control,
Validation, and Dating
If records are kept electronically, the system must
be validated and backed up, and access should be
limited to maintain control over any changes. Under
GDPs, only the most current document may be
used for any given purpose, and change control is a
must. Each document should be assigned an internal
control number, and revisions should be tracked.
Originators, reviewers, and approvers should be
identified and have appropriate qualifications to sup-
port their respective decisions.
Documentation should be dated in real-time
and never pre- or post-dated. Any retrospective
additions, modifications, or deletions should be
signed and dated having these changes witnessed
should be considered.
The time an organization should retain any given
documentation can vary, so care should be taken before
destroying any records. Documents often require
signatures. No document should be signed unless it is
understood, and the contents are supported.
An organization’s documents can be pivotal
in a product liability or personal injury case, and
it is possible they will be demanded during court
proceedings. Likewise, any person within an orga-
nization responsible for that documentation also
may be called into court. The credibility of a witness
or a product’s quality can be influenced greatly
by implementing GDPs. In today’s increasingly
litigious environment, all documentation should be
viewed through the lens of “could this document be
explained, justified, or defended in a court of law?”
Recordkeeping, Review, Training
Understandably, organizations are focused on get-
ting product out the door, but good documentation
improves processes and, ultimately, the bottom line.
An organization’s quality system is based on its doc-
umentation system. Even with the best intentions,
individual differences in execution or interpreta-
tion can result in inconsistencies and compromise
product quality. That is why it is best to implement
a GDP system at the earliest stages to minimize
subjective interpretation.
Good documentation is a significant investment
that may not bring immediate returns but provides
important protection against internal inconsisten-
cies, adverse regulatory actions, and legal liabilities.
The human resources required to respond to an
FDA 483 warrant the upfront investment in a docu-
mentation system that will mitigate communication,
performance, and recordkeeping failures. Any find-
ings of deficiencies are on the public record, available
to competitors and customers alike.
Building a Robust GDP System
Consider all Applicable Documentation
The following are some documents that should be
considered in regulated healthcare environments:
• Research and development
o Conception plans
o Prototype designs
o Specification requirements
o Clinical study protocols
o Investigator’s Brochures
o Investigational Review Board (IRB)
and investigator communications
o Informed consent forms
o Case Report Forms (CRFs)
o Investigator clinical study reports
• Sponsor narratives
• Commercialization
o FDA presubmission communications
o Supportive documentation for regula-
tory submissions
o Manufacturing standard operating
procedures (SOPs)
o Validation and stability reports
o Batch records
o COAs
o Labeling justifications and finalization
o Regulatory submissions
• Postmarket
o Market and launch documentation
o Proof of compliance with acceptable
practices and ISO requirements
o Pharmacovigilance reports
o Periodic safety updates
o Medical information communications
o Annual reports
o Supplemental filings
o Benefit-risk evaluation reports
o Serious adverse reaction reports
o Postmarket study requirements
o Advertising and promotional materials
and references
Good Practices for Signatures, Change Control,
Validation, and Dating
If records are kept electronically, the system must
be validated and backed up, and access should be
limited to maintain control over any changes. Under
GDPs, only the most current document may be
used for any given purpose, and change control is a
must. Each document should be assigned an internal
control number, and revisions should be tracked.
Originators, reviewers, and approvers should be
identified and have appropriate qualifications to sup-
port their respective decisions.
Documentation should be dated in real-time
and never pre- or post-dated. Any retrospective
additions, modifications, or deletions should be
signed and dated having these changes witnessed
should be considered.
The time an organization should retain any given
documentation can vary, so care should be taken before
destroying any records. Documents often require
signatures. No document should be signed unless it is
understood, and the contents are supported.
An organization’s documents can be pivotal
in a product liability or personal injury case, and
it is possible they will be demanded during court
proceedings. Likewise, any person within an orga-
nization responsible for that documentation also
may be called into court. The credibility of a witness
or a product’s quality can be influenced greatly
by implementing GDPs. In today’s increasingly
litigious environment, all documentation should be
viewed through the lens of “could this document be
explained, justified, or defended in a court of law?”
Recordkeeping, Review, Training
Understandably, organizations are focused on get-
ting product out the door, but good documentation
improves processes and, ultimately, the bottom line.
An organization’s quality system is based on its doc-
umentation system. Even with the best intentions,
individual differences in execution or interpreta-
tion can result in inconsistencies and compromise
product quality. That is why it is best to implement
a GDP system at the earliest stages to minimize
subjective interpretation.
Good documentation is a significant investment
that may not bring immediate returns but provides
important protection against internal inconsisten-
cies, adverse regulatory actions, and legal liabilities.
The human resources required to respond to an
FDA 483 warrant the upfront investment in a docu-
mentation system that will mitigate communication,
performance, and recordkeeping failures. Any find-
ings of deficiencies are on the public record, available
to competitors and customers alike.