quality audit shraddha

8/8/2019 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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