Regulatory Writing: An Overview
Third Edition
9 Regulatory Affairs Professionals Society
the basis for high-quality training. For smaller organizations
with limited resources, consultants specializing in GDPs are
available.
Good documentation not only supports and advances an
organization’s quality system but also safeguards public health
and can enhance employee retention. When everyone in an
organization understands what is expected, product quality
will be ensured, which enhances customer experience.
Acknowledgements
This chapter builds on the work of Joanne Rupprecht, Esq,
RAC whose coauthorship in the prior edition of this book is
deeply appreciated.
References
1 International Council for Harmonisation. Guideline for good clinical
practice-E6(R3). Dated 6 January 2025. Accessed 17 March 2025.
https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_
FinalGuideline_2025_0106.pdf
2 Food and Drug Administration. Data integrity and compliance
with drug CGMP: Questions and answers [guidance]. Current
as of 13 December 2018. Accessed 23 March 2025. https://www.
fda.gov/regulatory-information/search-fda-guidance-documents/
data-integrity-and-compliance-drug-cgmp-questions-and-answers
3 Pharmaceutical Research and Manufacturers of America. Code on inter-
actions with healthcare professionals. Dated 1 January 2021. Accessed 23
March 2025. https://cdn.aglty.io/phrma/global/resources/import/pdfs/
PhRMA%20Code%20-%20Final.pdf
4 Standard Protocol Items Recommendations for International Trials.
SPIRIT 2013 checklist. Accessed 23 March 2025. https://spirit-state-
ment.org/publications-downloads/
5 Enhancing the Quality and Transparency of Health Research-Equator
Network. Accessed 23 March 2025. https://www.equator-network.org/
6 Food and Drug Administration. Form FDA483 frequently
asked questions. Current as of 9 January 2020. Accessed 23
March 2025. https://www.fda.gov/inspections-compliance-en-
forcement-and-criminal-investigations/inspection-references/
fda-form-483-frequently-asked-questions
7 Food and Drug Administration. OII FOIA electronic reading room.
Current as of 11 March 2025. Accessed 23 March 2025. https://
www.fda.gov/about-fda/office-inspections-and-investigations/
oii-foia-electronic-reading-room
Third Edition
9 Regulatory Affairs Professionals Society
the basis for high-quality training. For smaller organizations
with limited resources, consultants specializing in GDPs are
available.
Good documentation not only supports and advances an
organization’s quality system but also safeguards public health
and can enhance employee retention. When everyone in an
organization understands what is expected, product quality
will be ensured, which enhances customer experience.
Acknowledgements
This chapter builds on the work of Joanne Rupprecht, Esq,
RAC whose coauthorship in the prior edition of this book is
deeply appreciated.
References
1 International Council for Harmonisation. Guideline for good clinical
practice-E6(R3). Dated 6 January 2025. Accessed 17 March 2025.
https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_
FinalGuideline_2025_0106.pdf
2 Food and Drug Administration. Data integrity and compliance
with drug CGMP: Questions and answers [guidance]. Current
as of 13 December 2018. Accessed 23 March 2025. https://www.
fda.gov/regulatory-information/search-fda-guidance-documents/
data-integrity-and-compliance-drug-cgmp-questions-and-answers
3 Pharmaceutical Research and Manufacturers of America. Code on inter-
actions with healthcare professionals. Dated 1 January 2021. Accessed 23
March 2025. https://cdn.aglty.io/phrma/global/resources/import/pdfs/
PhRMA%20Code%20-%20Final.pdf
4 Standard Protocol Items Recommendations for International Trials.
SPIRIT 2013 checklist. Accessed 23 March 2025. https://spirit-state-
ment.org/publications-downloads/
5 Enhancing the Quality and Transparency of Health Research-Equator
Network. Accessed 23 March 2025. https://www.equator-network.org/
6 Food and Drug Administration. Form FDA483 frequently
asked questions. Current as of 9 January 2020. Accessed 23
March 2025. https://www.fda.gov/inspections-compliance-en-
forcement-and-criminal-investigations/inspection-references/
fda-form-483-frequently-asked-questions
7 Food and Drug Administration. OII FOIA electronic reading room.
Current as of 11 March 2025. Accessed 23 March 2025. https://
www.fda.gov/about-fda/office-inspections-and-investigations/
oii-foia-electronic-reading-room