Quality Audit Shraddha
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Transcript of Quality Audit Shraddha
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Quality Audit
Prepared by :-
Shraddha ParmarM.Pharm 1styear(Quality Assurance)
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Contents
Definition
Objectives
Types of Quality AuditRole of GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Summary
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Quality Audit
It is a systematic and independent
examination to determine whether activitiesand related results comply with planned
arrangements and whether these
arrangements are implemented effectively
and are suitable to achieve objectives
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ObjectivesOf Quality Audit
To establish a high degree of confidence toremain under an adequate level of control by
management
Effective mechanism to verify compliance
with GMP regulation.
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To verify that manufacturing and Control
systems are operating under a state of control.
To permit timely correction of potentialproblems.
GMP audits with two important goals:-
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Types Of Quality Audit
Classified in three different categories:
1. Internal Audits
2. External Audits
3. Regulatory Audits
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Internal Audit
To Ensure that adequate Quality systems aremaintained.
To asses compliance with the C-GMP and confirmsstandard operating procedure.
To achieve consistency between manufacturing andtesting facilities.
To identify problems internally and Correct problemsprior to a FDA inspection.
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Types Of Internal Audit
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Tier One Tier Two Tier Three
Carried out Staff of a sectionor department ofcompany
Local Qualityassurance Group
Corporate ComplianceGroup And ExternalConsultant
PurposeRequire Short time& Focusing onhouse keeping &documentation
Require Longerperiod and morefocus on systemthan housekeeping
More focusing toassess the readinessof regulatory audit
Frequency More Less Less than tier 2
Qualification ofauditors
Receive Somebasic training
More exclusivetraining
Highly trained andexperienced orspecialist with theknowledge of GMP
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Implementing the Internal Audit Program :-
Designing of the Internal Audit System :-
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Constitute a small team of experts
Provide Initial training
Fix Audit schedule (Carried out at least once in Six months)
Report the Audit finding and report given to top management and Showscorrective actions
Repeat the audit as per preplanned Schedule
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ExternalAudit
Strong business benefits to be derived fromperforming these audits :-building knowledge and confidence in thepartnership arrangement
ensuring that requirements are understood and metenabling reduction of certain activities
External auditors typically have a broad practical
experience of GMP and receive quality systemsauditing training equivalent to that of ISO 9001 leadauditors
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Scope of the external audit:
The management shall discuss with the externalauditors the overall scope of the external auditincluding
identified risk areasany additional agreed-upon procedures
review the external auditors compensation toensure that an effective, comprehensive and
complete audit can be conducted for the agreedcompensation level.
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Purpose of Regulatory audit :-
Regulatory audit
Networking and confidence-building betweennational inspection authorities
Development of quality systems
Work towards global harmonization of GMP
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Carried out by regulatory bodies such asMCA(U.K),USFDA(USA) for manufacturing and
supply of pharmaceutical products
After regulatory audit: a formal report will bedelivered
For MCA:- verbal feedback report is givenat the exit meeting
For USFDA:-Provides Form 483 isgiven at the exit meeting
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Role of GMP Audits in Q.A And Q.C programs:
What is to be audited
Deficient Practices that requires Regulation/or
Administration
Benefits derived from Audits :
Assuring GMP compliance:-
Detecting Potential Problems:-Effecting Program improvement:-Increasing management awareness:-
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Elementsof a Systemic Audit Program
Key Elements
Expectations and Philosophies
Audit Formats and ApproachesChecklist format
GMP regulation approachSystem analysis methodsChecklist written criteria and Standard OperatingProcedures
Planned periodic frequency for audit
Specially trained personnel
Finding Written Audit reports 16
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Expectations and Philosophies:-
Formal Written Master Plan approved by management
Audit Formats and ApproachesChecklist format
GMP regulation approachSystem analysis methods
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CHECKLIST FORMAT
Checklist questions may introduce bias or have
hidden meanings and care needs to be that questionsdo not lead the auditor to answers that seem likelyE.g., Have all master formula records been properly
signed by a second person?person? (Careful examination of records to findimproperly signed record)
Inexperienced personnel may not fully understandthe intent of questions or may not recognize technical
issues that are readily apparent to experiencepersonnel
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GMP Regulation Format
Subparts of regulations
Subpart B: Organization and personnel
Subpart C: Building and facilities
Subpart D: Equipments
Subpart E: Production and Processing Controls
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Subpart F: Production and Packaging control
Subpart H: Holding and Distribution
Subpart I: Lab controls
Subpart J: Records and Reports
Subpart K: Returned and Salvaged drug
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Systemic Potential Problem Analysis
Written Criteria And SOP
Likely to Affect the Quality Of the Product
These FDA investigators describe the
organized method for determining of potentialproblem
Need to be established to define which audit data orelements are to be considered in the assessment ofprogram performance
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Planned Periodic Frequency
Announced VisitMajor adjustmenstsreliability
Unannounced AuditTo view conditions and practices thatis normal or customary (representative)is possible.
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Necessary records may be organizedKey personnel becomes available
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Specially Trained Personnel
Defining Auditor Qualification
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Defining auditor Qualification
Documentation training skills and Experience.
Selecting audit teams
Maintaining auditor awareness levels
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Documentation Training Skills And Experience:-
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Two Formats:-1.Scientific Principles2.GMP Knowledge
Selecting Audit Team:-
Leader is required for the auditing team who will
assess each members auditing skill
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Reporting Audit Finding :-
There are two important reporting phases:-
1. Preliminary reports during the audit
2. Final report to the management
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CONCLUSIONS AND RECOMMENDATIONS
Data may be viewed in different ways.The optimistic view:-audits have verified that system remainin suitable condition.The pessimistic view:- problems could exist that was notdetected by auditors.
If the situations where audit consistently detect problems.optimistic view:-need to modify the system and findcorrection.Pessimistic view:-auditor may have been overly critical or
too zealous.
Excellent management for the amount of the time and effortsare needed. So use of standardized coversheet that containthe important review elements
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Summary of Seminar
Quality audit is Periodic, independent and documentedexamination and verification of activities, records, processes,and other elements of a quality system to determine theirconformity with the requirements of a quality standard such as
USFDA and GMP.
A System Should be in place to ensure problems identifiedduring internal audits are corrected and preventive actions areimplemented when warranted
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References1. Pharmaceutical Dosage forms:Parenteral medication,Revised and
Expanded.Edited by Kenneth E.Avis,Herbert A.libermann and Leon
Lachmann,Volume3, Second edition , Page no:-363-420
2. Pharmaceutical Quality group monograph no:-5 (revised):
Pharmaceutical Auditing , IQA2001, ISBN 0906810 68X.3. Quality asuurance And Quality management in pharmaceutical
Industry By Y.Anjaneyulu,R.Marayya,Pharma Book syndicate, Page
no:-209-218.
4. Provisional Guideline ON the inspection of the pharmaceutical
manufacturers in: WHO Expert committee on specification for
Pharmaceutical Preparations: 32ndreport,Geneva,WHO,1992,
Annex-2(Who technical report seried. No:-823) 28
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Nobody likes to be audited..It is a mean to have continuous improvement
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Any Questions!!!!!
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