(2) quality audit-up
DESCRIPTION
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QUALITY AUDITPharmacist Profession Program
Faculty of Pharmacy-Pancasila University
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Really..????
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Introduction
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Quality Audit Systematic, Independent and documented process
for obtaining audit evidence and evaluating it objectively, to determine the extent to which audit criteria are fulfilled.
(ISO 9000:2005) It may be useful to supplement self inspection with
quality audit. Quality audit consist of an examination and assessment of all part of a quality management system with specific purpose of improving it.
(CPOB, 2012)
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Type of Quality Audit Audit Compliance
Compliance to obligation, legal requirement, regulation. Audit Performance
Organization target
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Principles of Auditinga. Integrity, foundation of professionalismb. Fair presentation, obligation to report truthfully
and accuratelyc. Due professional care, Application of diligence and
judgment in auditingd. Confidentiality, security of informatione. Independencef. Evidence-based approach
Principle of Self Inspection Purpose of self-inspection is to evaluate
whether a company’s operations remain compliant with GMP
Assists in ensuring quality improvement The programme should
cover all aspects of production and quality control
be designed to detect shortcomings in the
implementation of GMP
recommend corrective actions
set a timetable for corrective action to be completed
Principle of Self Inspection
Performed routinely Also on special occasions such as
Recalls
Repeated rejections
When a GMP inspection is announced by the
national drug regulatory authority
Principle of Self Inspection Self-inspection team should consist of
personnel who: can evaluate the situation objectively
have no conflict of interest, have no revenge in mind
should have experience as observers of a self-
inspection team before becoming a team member
can be lead self-inspector with experience as team
member
Procedure should be documented Effective follow-up programme
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Definitions1. Auditor : executor2. Auditee : object3. Lead Auditor : team leader4. Minor finding 5. Major finding 6. Critical finding 7. CAPA : Corrective Action & Preventive Action
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Internal Audit OrganizationPlant Manager
QA Manager
Lead Auditor
Auditor Member Auditor MemberAuditor Member
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Quality Audit Cycles
Preparation•Receiving Audit Brief
• Identify Scope• Identify Resources•Document Review•Create Audit Plan•Create Checklist
Conducting•Opening Meeting•Tour of Site•Generating Audit Findings & Conclusions
Reporting & Follow up•Prepare report•Closing Meeting•Follow up of Corrective Action
Surveillance
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Preparation Receiving Audit Brief : from Auditee or
QA (internal) Identify Scope : Scope of process
that will be audited Identify Resources : What auditor
need?? Document review Create Audit Plan : Rundown audit and
send to auditee Create Checklist : As guidelines
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Lead AuditorResponsibilities :1. To manage team2. Make audit planning3. As team representative4. Make final report5. Lead audit meeting
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Conducting Opening meeting : Audit objective,
greetings Tour of Sites : Verify Conducting and Conclusion
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Audit Findings Nonconformity (NC)
Problem Statement
Evidence Requirement
NC
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Grading Findingsa) Critical: A deficiency which has produced, or may
result in a significant risk of producing, a product which is harmful to the intended user.
b) Major: A deficiency which has produced or may produce which does not comply with its marketing authorization/specifications; and/or indicates a major deviation from the regulation or standard.
c) Minor: A deficiency which cannot be classified as either critical or major, but which may indicate a departure from GMP.
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Reporting and Follow Up Prepare report : A report should be
made at the completion of self inspection.The report should include : Result Evaluation & conclusion Recommended corrective action
Closing Meeting : Report Auditing Result
Follow Up
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SurveillanceThe continuing monitoring and
verification of the status of procedures, methods, conditions, processes, products and services, and the analysis of record. In relation to stated references to ensure the specified requirements of Quality are being met.