Top 22 Tips: Writing For FDA Compliance

Copyrighted 2013, Compliance Insight, Inc.

Top 22 Tips:Writing for FDA Compliance

Troy Fugate

Compliance Insight, Inc.

Investigator, Auditor


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


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”


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


Poor Documentation

• Examples– None– Confusing, unclear, vague

• Consequences– Release bad product– Reject good product– Legal issues– Reputation

• FDA• Public


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!!!!!


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!


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


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


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


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


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:


How to write

• Select a format and stick with it

• Select a report format– Introduction– Outline of investigation– Summary of investigation– Conclusion– CAPA


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)


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


http://www.compliance-insight.com/

mailto:[email protected]

Top 22 Tips: Writing For FDA Compliance

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