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Internal audit training
1) Internal audits are required by cGMP and QMS standards to evaluate compliance and identify improvement opportunities. They help assure compliance, detect potential problems, and increase management awareness. 2) There are different types of audits - internal, external by suppliers, and regulatory. Audits check areas like personnel, facilities, equipment, production, documentation, and quality systems. 3) Principles of effective auditing include ethical conduct, fair presentation, independence, evidence-based approach. Audit planning includes preparing the audit plan, selecting the team, and arranging logistics. Frequency depends on the compliance risk of the area.
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Internal audit training
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- 2. What is Audit..?? •Systematic, independent & documented examin ation to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented ef fectively and are suitable to achieve objectives.
- 3. Objective of audits..?? •Audits are basic requirement of cGMP and QMS. • Pharmaceutical manufacturers commonly use a udits as an effective mechanism to verify comp liance with GMP regulation (GMP). • To evaluate the manufacturer’s Compliance wi th GMP in all aspects of production and Qualit y control.
- 4. Benefits of Auditing… •Assure cGMP Compliance • Detect Potential Problems • Increased management awareness. • Reduce Risk of failure • Identifies improvement opportunities.
- 5. Types of Audit InternalAudit (1st party) Organization Auditing its own system External Audit (2nd party) Organization Auditing its suppliers Regulatory or certification body au dit (3rd Party) Organization Audited by regulatory body or any certification body.
- 6. Items of Audit… •Personnel • Premises • Mentainance of buildings and equipment's • Storage of starting material and finish products • Equipment • Production and in-process control
- 7. Items of Audit… •Documentation • Sanitation & Hygiene • Validation • QMS
- 8. Principles of Auditing EthicalConduct • Trust, Integrity, confidentiality & discretion. Fair Presentation • Audit finding and conclusion are Independence • Auditors are independent of activities being a udited and are free from bias or conflict of int erest. • Conclusion of audit should be objective and e vidence based only. Evidence Based Approach • Audit evidence is based on samples of Inform ation • Conclusion are verifiable
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- 10. Frequency of InternalAudit: • Each area / department must be audited once in a year. However audit frequency of critical are as (i.e., Production, Warehouse & Quality Cont rol) will be decided on the basis of risk based a ssessment of current cGMP compliance level o f that area as shown in table I.
- 11. Frequency of InternalAudit: Compliance issues Compliance Score Compliance Risk Frequency ≥ 1 critical observations Poor High Quarterly ≥ 5 major observations Poor High Quarterly 2-4 Major Observations Average Medium Biannual >10 < 25 minor observations Average Medium Biannual ≥ 10minor observations Satisfactory Low Annual
- 12. Audit Planning • PreparePlan send the copy to all stake holders • Get Conformation from Auditee • Decide team • Arrange team briefing • Team prepare checklist/ agenda • Conduct Audit
- 13. Selecting Audit Teamfor Internal Audit
- 14. Who Is InternalAuditor…?? A person who has qualification to perform intern al Audit. Person Selected as an internal Audit should be. Free From Bias Independent of activity being au dited Free from influe nce
- 15. Internal Audit Team.. •Cross functional team is selected to conduct au dit. • Individuals in team are selected on basis of ❖Experience and knowledge ❖Familiarization with current guidance and company's procedures. • Size of audit team depends upon complexity of area to be audited
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- 17. Planning Preparation Conduct Compile Audit report ShareAudit Report Follow-up Close-Out Audit Cycle Auditor Auditee
- 18. Personal Conduct DuringAudit…. • Auditor Should have Positive, professional & c onstructive approach. • Auditor should be Co-operative, open &honest .
- 19. Audit Do’s….. • Beprepared for audit • Be punctual • Insist on Auditee answering question • As little talking as possible • Avoid misunderstanding • Keep question clear & concise • Polite & calm
- 20. Audit Don’ts… Do not •Be side tracked • Be led or misled • Get bogged down • Let Auditee dictate the place • Make assumption or presumptions
- 21. Auditor’s Should… • Staywithin audit scope • Communicate audit requirement • Collate objective evidence • Report audit findings • Verify effectiveness of corrective actions • Retain and safeguard documents
- 22. During Audit Bewareof… • Aggressive Auditee's • Timid Auditee's • Missing People • Missing Documents • Pre-pared sample (Choose your own) • Auditee pretend to be busy • Emotional Blackmail
- 23. Closing Meeting • Presentall findings and evidences carefully & precisely • Be prepared to support and justify findings • Do not be drawn into arguments • If an error transpires, apologize • Alter or withdraw if necessary
- 24. Post Audit Activities.. •Prepare Audit report • Write audit observations and categorize these a s minor, major & critical. • Write areas of improvement. • Share compiled audit report to Auditee within week.
- 25. Audit Report… Should Include •Agreed Audit agenda • Audit criteria • Date and location of audit • Duration • Summary of audit findings
- 26. Audit Follow Up& Close Out
- 27. Follow Up ofthe Corrective Actions • To ensure corrective action has prevented any recurrences • To determine whether corrective action has be en effective. Why follow up
- 28. Close Out ofFindings… • Each finding of audit is to be close out individ ually. • Ensure that corrective action has addressed the root cause of findings. • Not treated symptoms only but prevented recur rence of nonconformity. • When auditor is satisfied there is no further ex ample of nonconformance.
- 29. References: • EU GMPEudraLex Volume 4 (Part I), Chapter 9 • WHO TRS 986, Annex 2 • PICS guideline PE009-13 (Part I), Chapter 9. • ISO 9001:2015 Quality Management System • ISO 19011:2011 Auditing Management System