Top 22 ways to create documents that will achieve FDA Compliance. Create your documents the right way to stay compliance with the FDA

1. Copyrighted 2013, Compliance
Insight, Inc.
Top 22 Tips:
Writing for FDA Compliance
Troy Fugate
Compliance Insight, Inc.
Investigator, Auditor

2. Copyrighted 2013, Compliance
Insight, Inc.
This presentation will cover…
• Why we document?
• If we don’t document or document poorly,
what are the consequences.
• Good writing overview
• Report writing tips

3. Copyrighted 2013, Compliance
Insight, Inc.
Why document?
• It is the law!
– Thou shall document
• 211.192
– “A written record of the investigation
shall be made and shall include the
conclusions and follow-up”
• Guidance “Investigating OOS Test
Results for Pharmaceutical
Production”

4. Copyrighted 2013, Compliance
Insight, Inc.
Formal Documentation
• The goal is to clearly describe:
– The issue or problem
– The paths taken during the
investigation
– CAPA
– Conclusion
• Prevents errors due to oral
communication
• Prevents errors due to informal
documentation

5. Copyrighted 2013, Compliance
Insight, Inc.
Poor Documentation
• Examples
– None
– Confusing, unclear, vague
• Consequences
– Release bad product
– Reject good product
– Legal issues
– Reputation
• FDA
• Public

6. Copyrighted 2013, Compliance
Insight, Inc.
What are you going to document?
• All GMP related operations
– Manufacturing
– Packaging
– Testing
– Etc.
• Investigations
• Complaints
You are going to document
just about everything in
pharmaceutical operations
– especially dealing with
quality!!!!!

7. Copyrighted 2013, Compliance
Insight, Inc.
The Top 22 Tips…
1. Be clear, concise and timely
2. Clearly summarize the issue
3. Include all pertinent items found during
the investigation
4. Have a conclusion
5. Indicate CAPA
6. Be approved – QA ++++
7. Be communicated to the appropriate
people
If you don’t have a
conclusion, the FDA
will make one for you!

8. Copyrighted 2013, Compliance
Insight, Inc.
The Top 22 Tips…
8. Not assume anything
– The reader may not know
• The process (or know if very well)
• The product
• The history
8. Use charts, tables, graphs
9. Do Not use slang, jargon
10.Backup findings with evidence, data
11.Do Not exaggerate

9. Copyrighted 2013, Compliance
Insight, Inc.
The Top 22 Tips…
13.State the scope of the problem or issue
14.Outline the root cause
15.Indicate CAPA
– Systemic approach
13.Flows well
– Paragraphs connected via some form of
thought process
13.Use bullet points as necessary

10. Copyrighted 2013, Compliance
Insight, Inc.
The Top 22 Tips…
18.List key dates and times
19.Timeline of the investigation
20.Contain copies of reference data
21.Contain copies of CAPA items
– Training
– Purchases
– Employee issues – NO (this is personal)
18.Be all inclusive to the incident
– Don’t stop just because you “think” you found the
problem

11. Copyrighted 2013, Compliance
Insight, Inc.
How to write
• Place yourself in the background
• Use nouns and verbs
– Minimal use of adjectives and adverbs
• Revise, revise, revise
– Let others not involved with the issue read the
report
– Remember, the next person to read this
report may be the FDA

12. Copyrighted 2013, Compliance
Insight, Inc.
How to write
• Avoid “local” or technologically advanced
wording
• Do not inject opinion
• Spell out abbreviations
• Be specific
– The product didn’t meet specifications.
– Better: Product Fugatium Bromide, Tablets,
10 mg, did not meet potency specifications of
92 – 102% as dictated in the USP. The
results were as follows:

13. Copyrighted 2013, Compliance
Insight, Inc.
How to write
• Select a format and stick with it
• Select a report format
– Introduction
– Outline of investigation
– Summary of investigation
– Conclusion
– CAPA

14. Copyrighted 2013, Compliance
Insight, Inc.
How to write
• Put statements in a positive form
• Use definite, specific language
• Don’t include needless wording or
statements
• Check your data (calculation errors have
resulted in further problems)

15. Copyrighted 2013, Compliance
Insight, Inc.
How to write
• The next reader will probably be an
auditor
• Begin with the end in mind
– (i.e. What is your goal?)
• Include all areas of the investigation
– Even those that resulted in “no issues noted”
• Indicate results, expected ranges and
specifications (internal, NDA, ANDA, USP)

16. For More Information or Help…
• Give us a call at:
– 513-860-3512
– www.Compliance-Insight.com
– FDATrainingTeam@compliance-insight.com
– Free consultation by phone
Copyrighted 2013, Compliance
Insight, Inc.