Regulatory Writing: An Overview 22
Any documentation system should contain
clear, consistent, and focused documents, includ-
ing SOPs and training materials. Inconsistencies
or ambiguities can have devastating effects on an
organization’s operations. Thus, documents should
be reviewed periodically and reconciled with each
other to minimize confusion among users. The
organization should determine which are specific to
its operations and customize policies and procedures
accordingly. For example, processes and procedures
not currently in place, even if they once were, should
not be documented.
Change control will ensure all users are using
the most up-to-date version of a document, and
an organized change control procedure should be
developed and followed. A document change control
system is intended to capture changes made to exist-
ing documentation and provide a means of tracking
these changes and communicating them throughout
an organization.
If an organization’s operations deal with med-
ical devices and pharmaceuticals, documentation
for each product type should be kept separately.
Likewise, specific provisions may be necessary for
documents related to an organization’s pharmaceuti-
cal products if they are DEA-controlled substances,
biologics, generics, etc.
Once the documentation system is in place, it
should not be neglected or abandoned. Changes
should be considered regularly, following schedules
mandated in regulations or in conjunction with
other appropriate events. In the event of an audit,
the trail of the changes made, the dates of those
changes, and the parties responsible for them should
be identified easily, and support for those changes
should be kept on file accordingly. Documenting the
obvious can make short work of inspections. One
test for whether updates are required is to answer
the question, “can you explain how this (i.e., the
subject matter of the document) all works?” It is
not unreasonable for an auditor to expect a docu-
ment user to explain the contents or their relevance
to business operations. If a document, as written,
cannot translate information to the reader to allow
informed decisions to be made, reworking the docu-
ment is advisable.
Training is vital to success, but such training
is only as good as the documentation on which
it is based. High-quality documents are the basis
for high-quality training. In smaller organizations
without a dedicated technical writer, consultants
specializing in GDPs are available.
Good documentation not only supports and
advances an organization’s quality system but safe-
guards public health and can enhance employee
retention. When everyone in an organization under-
stands what is expected, product quality will be
ensured, and the customer experience will be enhanced.
References
1. Data Integrity and Compliance with CGMP: Guidance for
Industry. FDA website. https://www.fda.gov/media/97005/
download. Accessed 25 September 2020.
2. Form FDA 483 Frequently Asked Questions. FDA web-
site. http://www.fda.gov/ICECI/Inspections/ucm256377.
htm. Accessed 25 September 2020.
3. ORA FOIA Reading Room. FDA website. http://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofGlobalRegulatoryOperationsandPolicy/ORA/
ORAElectronicReadingRoom/default.htm. Accessed 25
September 2020.
4. Ibid.
Any documentation system should contain
clear, consistent, and focused documents, includ-
ing SOPs and training materials. Inconsistencies
or ambiguities can have devastating effects on an
organization’s operations. Thus, documents should
be reviewed periodically and reconciled with each
other to minimize confusion among users. The
organization should determine which are specific to
its operations and customize policies and procedures
accordingly. For example, processes and procedures
not currently in place, even if they once were, should
not be documented.
Change control will ensure all users are using
the most up-to-date version of a document, and
an organized change control procedure should be
developed and followed. A document change control
system is intended to capture changes made to exist-
ing documentation and provide a means of tracking
these changes and communicating them throughout
an organization.
If an organization’s operations deal with med-
ical devices and pharmaceuticals, documentation
for each product type should be kept separately.
Likewise, specific provisions may be necessary for
documents related to an organization’s pharmaceuti-
cal products if they are DEA-controlled substances,
biologics, generics, etc.
Once the documentation system is in place, it
should not be neglected or abandoned. Changes
should be considered regularly, following schedules
mandated in regulations or in conjunction with
other appropriate events. In the event of an audit,
the trail of the changes made, the dates of those
changes, and the parties responsible for them should
be identified easily, and support for those changes
should be kept on file accordingly. Documenting the
obvious can make short work of inspections. One
test for whether updates are required is to answer
the question, “can you explain how this (i.e., the
subject matter of the document) all works?” It is
not unreasonable for an auditor to expect a docu-
ment user to explain the contents or their relevance
to business operations. If a document, as written,
cannot translate information to the reader to allow
informed decisions to be made, reworking the docu-
ment is advisable.
Training is vital to success, but such training
is only as good as the documentation on which
it is based. High-quality documents are the basis
for high-quality training. In smaller organizations
without a dedicated technical writer, consultants
specializing in GDPs are available.
Good documentation not only supports and
advances an organization’s quality system but safe-
guards public health and can enhance employee
retention. When everyone in an organization under-
stands what is expected, product quality will be
ensured, and the customer experience will be enhanced.
References
1. Data Integrity and Compliance with CGMP: Guidance for
Industry. FDA website. https://www.fda.gov/media/97005/
download. Accessed 25 September 2020.
2. Form FDA 483 Frequently Asked Questions. FDA web-
site. http://www.fda.gov/ICECI/Inspections/ucm256377.
htm. Accessed 25 September 2020.
3. ORA FOIA Reading Room. FDA website. http://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofGlobalRegulatoryOperationsandPolicy/ORA/
ORAElectronicReadingRoom/default.htm. Accessed 25
September 2020.
4. Ibid.