Quality audits

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QUALITY AUDITS BY J. PARVEEN SULTANA UNDER THE GUIDANCE OF Dr.T.MAMATHA . M.Pharm.,Ph.D 1

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CONTENTS INTRODUCTION TYPES OF AUDIT PRINCIPLES AND OBJECTIVES TOOLS OF AN AUDITOR AUDITOR QUALIFICATIONS AUDIT LIFECYCLE INTERNAL AUDIT PROCESS THIRD PARTY AUDIT PROCESS CONCLUSION REFERENCES 2

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INTRODUCTION QUALITY AUDIT A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve stated objectives. 3

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TYPES OF AUDIT INTERNAL AUDIT(FIRST PARTY AUDIT) EXTERNAL AUDIT: SECOND PARTY THIRD PARTY AUDIT SUB-TYPES 4

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PRINCIPLES OF AUDITING ETHICAL BEHAVIOUR FAIR PRESENTATION APPROPRIATE PROFESSIONALISM INDEPENDENCE EVIDENCE BASED APPROACH 5

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OBJECTIVES OF QUALITY AUDIT To determine conformity and non conformity of the quality system elements with specified requirements. To determine the effectiveness of the implemented quality system in meeting specified quality objectives. To afford an opportunity to improve the quality system. To provide managers with information. Recommendation and corrective action. Improvement in monitoring . Built confidence in GMP and QA systems 6

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TOOLS OF THE AUDITOR DOCUMENTS PREVIOUS AUDIT AND FOLLOW-UP REPORTS AUDIT CHECKLIST AUDIT PLAN AUDITEE’S OWN DOCUMENTS AND AIDES MEMORY AUDITORS OWN EYES, EARS, BRAIN,WORDS etc. 7

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AUDITOR QUALIFICATIONS Education Experience Training Mental Stability Competence Communication 8

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INTERNAL AUDIT PROCESS 10

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  Audit process consists of four stages: Planning (sometimes called survey or preliminary review) Fieldwork Audit report Follow-up review Client involvement is critical at each stage of the audit process.   11

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PLANNING Announcement Letter Initial meeting Preliminary Survey Audit Program FIELD WORK Transaction Testing Advice and Informal Communication Audit Summary Working Papers 12

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AUDIT REPORT Discussion Draft Exit Conference Formal Draft Final Report Client Response Client Comments Audit Follow Up FOLLOW UP REVIEW Follow up report Internal Audit Report to the Board     13

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THIRD PARTY AUDIT PROCESS 14

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(a) Request by the Auditee : self assessment of GMP status (b) Request by the QP(s) or Responsible Person(s) of the Manufacturing Authorisation Holder(s): Third Party Audit of API Starting Material used In Medicinal Products. 15

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(c) QP(s) contact(s) ACI (d) ACI contacts the Auditee and sends the pre-audit questionnaire and contacts two APIC certified auditors 16

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(e) ACI informs the Auditee and the QP(s) about the names of the chosen APIC certified auditors. Both the Auditee and/or the QP(s) can refuse one or both auditors (e.g. due to competition reasons ) 17

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( i ) After having reviewed that proposed actions have been defined for any deficiencies the auditors sign the final audit report that is sent to the ACI. (j) The ACI sends copies of the signed audit report to the customer(s) and to the Auditee and archives the original signed audit report. 20

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In conclusion ....... An optimal and well maintained Good Manufacturing Practices Quality Management system is important to ensure the quality, safety, and efficacy of drug deliveries to patients. Inspections and Audits are important to control the principles of GMP in Manufacturing plants during the entire Supply Chain of drugs. 21

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REFERENCES : 1.How to practice GMP,1 st Edition , P.P.Sharma 2.QA and QM in pharmaceutical Industry- Anjaneyulu.Y 3.The APIC Audit Programme Revision version 3 August 2010 4.www.google.com 5.www.Elsmar.com 22

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THANK YOU 23

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