third party quality audits

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CONTENTS INTRODUCTION TYPES OF AUDIT PRINCIPLES AND OBJECTIVES AUDIT LIFECYCLE TOOLS OF AN AUDITOR QUALIFICATION AND ATTRIBUTES OF AUDITORS AUDIT PROCESS ADVANTAGES AND DISADVANTAGES THIRD PARTY AUDIT CHECKLIST CONCLUSION REFERENCES

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1.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

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

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3.PRINCIPLES: FAIR BEHAVIOUR FAIR PRESENTATION APPROPRIATE PROFESSIONALISM INDEPENDENCE EVIDENCE BASED APPROACH

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OBJECTIVES: Quality audit are an essential element of the Quality assurance function . The general objectives of quality audits are: 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

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PHASES OF AUDITING P lanning and P reparation of audit E xecution of the audit plan R eporting the audit results C lose out of corrective actions

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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.

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Auditor Qualifications Education Experience Training Proficiency Competence Communication

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PERSONAL ATTRIBUTES Auditor should : Be open minded and mature Posses sound judgement Have analytical skills an tenacity Have the ability to perceive situations in a realistic way Understand and complex operations from a broad perspective Understand the role of individual units with in the overall organization.

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AUDIT PROCESS

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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

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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)

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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.

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ADVANTAGES OF THIRD PARTY : 3 rd party auditor is a professional, has experience in the auditing practice Usually has a better management view and can analyze the QMS as a whole By using a 3rd party to conduct the audit, the top management will sort of pressured to take care of these types of items. It's always good to have an outsider to review your system anyhow.

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DISADVANTAGES OF THIRD PARTY AUDIT First party auditor know the QMS being audited better than a third party audit. First party audit know the interaction of the processes better. First party audit know the auditees and the general ins and outs. The internal audit tends to be more “deeper” and gets to find more “stuff”.

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THIRD PARTY AUDIT CHECKLIST: Notification of third-party audit Preparation of third party audit During third party audit Post third party audit

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Check List Benefits Keeps Objective On Track Shows Evidence Of Planning Maintains Place and Consistency Decreases Workload and Time Requirement Records Audit Sample Exhibits Professionalism

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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. Third party GMP audits are helpful to build and sustain a well balanced Quality Management system for GMP.

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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 2010s 4.www.google.com 5.www.Elsmar.com

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