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Top 22 Tips: Writing For FDA Compliance
The document provides key insights and tips for effective documentation in pharmaceutical compliance, emphasizing the importance of clarity and thoroughness to avoid legal and operational consequences. It outlines best practices for documenting investigations, CAPA (Corrective and Preventive Actions), and compliance with FDA regulations. The presentation includes 22 specific recommendations to enhance report writing and ensure precise communication of issues and findings.
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Top 22 Tips: Writing For FDA Compliance
- 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 Informationor 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.