top 22 tips: writing for fda compliance
DESCRIPTION
Top 22 ways to create documents that will achieve FDA Compliance. Create your documents the right way to stay compliance with the FDATRANSCRIPT
Copyrighted 2013, Compliance Insight, Inc.
Top 22 Tips:Writing for FDA Compliance
Troy Fugate
Compliance Insight, Inc.
Investigator, Auditor
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
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”
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
Copyrighted 2013, Compliance Insight, Inc.
Poor Documentation
• Examples– None– Confusing, unclear, vague
• Consequences– Release bad product– Reject good product– Legal issues– Reputation
• FDA• Public
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!!!!!
Copyrighted 2013, Compliance Insight, Inc.
The Top 22 Tips…1. Be clear, concise and timely2. Clearly summarize the issue3. Include all pertinent items found during
the investigation4. Have a conclusion5. Indicate CAPA6. Be approved – QA ++++7. Be communicated to the appropriate
people
If you don’t have a conclusion, the FDA will make one for you!
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
9. Use charts, tables, graphs10.Do Not use slang, jargon11.Backup findings with evidence, data12.Do Not exaggerate
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
16.Flows well– Paragraphs connected via some form of
thought process
17.Use bullet points as necessary
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)
22.Be all inclusive to the incident– Don’t stop just because you “think” you found the
problem
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
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:
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
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)
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)
For More Information or Help…
• Give us a call at:– 513-860-3512– www.Compliance-Insight.com – [email protected] – Free consultation by phone
Copyrighted 2013, Compliance Insight, Inc.