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It is a documented and systematic tool It should be done periodically by independent and qualified people ROLES OF IA : ROLES OF IA As a powerful tool to measure the effectiveness of quality management system Evaluates manufacturer’s compliance with GMP in all aspects related production and quality control Detects any shortcomings in the implementation of GMP Recommend the necessary corrective and preventive actions SCOPE OF IA (1) : SCOPE OF IA (1) Ensures quality in design, approval, monitoring and evaluation of products should comply GMP requirements Ensures quality in GMP implementation and its strategies Ensures quality in appointment, development and performance of staff and key personnel Ensures quality in obtaining and responding to the feedbacks from customers, consumers, employers, employees, government authority and other relevant institutions SCOPE OF IA (2) : SCOPE OF IA (2) Includes all written quality documents, instructions and records Covering all elements of GMP including results of previous internal quality audit and any corrective and preventive actions (CAPA) taken BENEFITS OF IA : BENEFITS OF IA Tells you the health of a quality system Identify the root of a problem and plan for corrective and preventive actions with timeline Achieve better allocation of resources Able to avoid potentially big problem Learn what an auditors look for Continuous improvement KEY PRINCIPLES OF IA : KEY PRINCIPLES OF IA Approaches towards IA: Independent Evidence-based approach All activities related to IA should: be reviewed by an independent party be a self-appraisal system have a sampling plan and tracking system be open, constructive and effective Strategies in conducting audit: Ask with the basic audit questions about the quality system in place Start with what, why, how, who, where, when PRINCIPLE OF AN AUDITOR : PRINCIPLE OF AN AUDITOR Ethical Professional Fair GUIDANCE WHEN CONDUCTING AN AUDIT : GUIDANCE WHEN CONDUCTING AN AUDIT Auditing should be seen as a positive process not a fault finding Audits need to be documented Prior to the audit date, an auditor needs to review the quality system documentation, corrective and preventive actions, and past audit findings and develop a checklist During an audit, an auditor need to see evidences that the processes are being done in accordance to procedures and policies GUIDANCE FOR AUDITEE : GUIDANCE FOR AUDITEE When being audited: Volunteer information Report deficiencies and difficulties if you know of any Be honest, open and cooperative Ensure that underlying causes are identified Ask the auditor if you’re not sure MANAGING IA : MANAGING IA FLOW CHART OF IA : FLOW CHART OF IA RESOURCES FOR IA : RESOURCES FOR IA Considerations should be given to the following: Resources Audit techniques Processes to achieve and maintain the competency of auditors and to improve their performance Competency and availability of auditor Available time for auditing PLANNING : PLANNING The planning of IA consists of : Authority for administering the IA program Establishing IA program Objectives Responsibility Procedure and guidance IA IMPLEMENTATION : IA IMPLEMENTATION The implementation of IA program consists of : Scheduling audit Implementation of audit program Audit record and report IA MONITORING : IA MONITORING Implementation of audit program should be monitored at appropriate intervals and reviewed to assess whether its objectives have been met and identified opportunities for improvement. Auditing findings should be reported to the management. AUDITING ACTIVITIES : AUDITING ACTIVITIES AUDIT DOCUMENTATION : AUDIT DOCUMENTATION Audit plan should be sent to auditee prior to audit activity findings from the last audit should be also mentioned Audit note should include an audit questionnaire all records and comments during the audit Audit report is an official document to report the audit findings EXAMPLE OF AN AUDIT CHECKLIST : EXAMPLE OF AN AUDIT CHECKLIST General format for an audit checklist EXAMPLE OF AN AUDIT CHECKLIST : EXAMPLE OF AN AUDIT CHECKLIST IA MONITORING : IA MONITORING AUDIT MONITORING : AUDIT MONITORING The audit finding can be classified into 2 groups: Compliance : Satisfactory /Adequate Outstanding Non-compliance : Critical deficiency Major deficiency Minor deficiency AUDIT REPORT : AUDIT REPORT Objectives Audit scope Identification of audit team leader and members Date and place where the on-site audit activities were conducted Audit criteria and findings Conclusions AUDIT REPORT : AUDIT REPORT Various formats can be used depending on auditee (vendors, management or auditee) Usually include name and location of auditee, date of audit, audit plan, audit observations, classification of non-compliances, recommendations or expectations Should write against a standard Focus on deficient conditions and not people Include any positive observations Keep the audit report simple and clear AUDIT REPORT: AN EXAMPLE : AUDIT REPORT: AN EXAMPLE CLOSURE : CLOSURE Receive a satisfactory response from auditee and their commitment to correct for any deficiency Ensures CAPA identify the root cause and they are satisfactory, accomplished and documented Timeframe for CAPA is being followed Verify and track CAPA by scheduling a follow-up audit and/or requesting for an updated SOP CONCLUSIONS : CONCLUSIONS Nobody likes to be audited……….. It is a means to have continuous improvement THANKS : THANKS You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.