Copyrighted 2013, ComplianceInsight, Inc.Top 22 Tips:Writing for FDA ComplianceTroy FugateCompliance Insight, Inc.Investigator, Auditor
Copyrighted 2013, ComplianceInsight, 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, ComplianceInsight, Inc.Why document?• It is the law!– Thou shall document• 211.192– “A written record of the investigationshall be made and shall include theconclusions and follow-up”• Guidance “Investigating OOS TestResults for PharmaceuticalProduction”
Copyrighted 2013, ComplianceInsight, Inc.Formal Documentation• The goal is to clearly describe:– The issue or problem– The paths taken during theinvestigation– CAPA– Conclusion• Prevents errors due to oralcommunication• Prevents errors due to informaldocumentation
Copyrighted 2013, ComplianceInsight, Inc.Poor Documentation• Examples– None– Confusing, unclear, vague• Consequences– Release bad product– Reject good product– Legal issues– Reputation• FDA• Public
Copyrighted 2013, ComplianceInsight, Inc.What are you going to document?• All GMP related operations– Manufacturing– Packaging– Testing– Etc.• Investigations• ComplaintsYou are going to documentjust about everything inpharmaceutical operations– especially dealing withquality!!!!!
Copyrighted 2013, ComplianceInsight, Inc.The Top 22 Tips…1. Be clear, concise and timely2. Clearly summarize the issue3. Include all pertinent items found duringthe investigation4. Have a conclusion5. Indicate CAPA6. Be approved – QA ++++7. Be communicated to the appropriatepeopleIf you don’t have aconclusion, the FDAwill make one for you!
Copyrighted 2013, ComplianceInsight, Inc.The Top 22 Tips…8. Not assume anything– The reader may not know• The process (or know if very well)• The product• The history8. Use charts, tables, graphs9. Do Not use slang, jargon10.Backup findings with evidence, data11.Do Not exaggerate
Copyrighted 2013, ComplianceInsight, Inc.The Top 22 Tips…13.State the scope of the problem or issue14.Outline the root cause15.Indicate CAPA– Systemic approach13.Flows well– Paragraphs connected via some form ofthought process13.Use bullet points as necessary
Copyrighted 2013, ComplianceInsight, Inc.The Top 22 Tips…18.List key dates and times19.Timeline of the investigation20.Contain copies of reference data21.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 theproblem
Copyrighted 2013, ComplianceInsight, 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 thereport– Remember, the next person to read thisreport may be the FDA
Copyrighted 2013, ComplianceInsight, Inc.How to write• Avoid “local” or technologically advancedwording• 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 of92 – 102% as dictated in the USP. Theresults were as follows:
Copyrighted 2013, ComplianceInsight, 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, ComplianceInsight, Inc.How to write• Put statements in a positive form• Use definite, specific language• Don’t include needless wording orstatements• Check your data (calculation errors haveresulted in further problems)
Copyrighted 2013, ComplianceInsight, Inc.How to write• The next reader will probably be anauditor• 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 andspecifications (internal, NDA, ANDA, USP)
For More Information or Help…• Give us a call at:– 513-860-3512– www.Compliance-Insight.com– FDATrainingTeam@compliance-insight.com– Free consultation by phoneCopyrighted 2013, ComplianceInsight, Inc.