A Seminar On Quality Audit Prepared by :- Chaitrali D.Gole M.Ph (Q.A Sem-1) R.D.C.O.P Bhor.

2. ASeminaronQualityAuditASeminaronQualityAudit
Prepared by :-
Miss.Chaitrali Gole
Prepared by :-
Miss.Chaitrali Gole
M.Pharm Semester first
(Quality assurance)
M.Pharm Semester first
(Quality assurance)

3.  Definition
 Self inspection
 Types of Quality Audit
 Objectives
 Role OF GMP Audit in QA and QC programmes
 Elements of a Systemic Audit Program
ContentsContents

7. Principle:-
 To evaluate the manufacturer’s Compliance with
GMP in all aspects of production and Quality control.
 Designed to detect any shortcomings in the
implementation of GMP and to recommend the
necessary corrective actions.
 Performed routinely as well as on special occasions,
e.g. in the case of product recalls or repeated
rejections.
Self InspectionSelf Inspection

8.  Personnel
 Premises including personnel facilities
 Maintenance of buildings and equipment
 Storage of starting materials and finished
products
 Equipment
 Production and in-process controls
 Quality control
To be Continued………
Items of Self inspectionItems of Self inspection

9.  Documentation
 Sanitation and hygiene
 Validation and revalidation programmes
 Calibration of instruments or measurement
 systems
 Recall procedures
 Complaints management
 Labels control
 Results of previous self-inspections and any
corrective steps Taken
Conti.…

29. What is to be audited:-
Auditors review
SOPs
Employees Pracices and behaviour
 Compare master specifications against compendial
and regulatory requirements
 Verify the test data and validation testing
 Validation test reports are compared against raw data
 Verify Corrective actions taken inreaction to audit finding
To be Continued………
Role of GMP Audits in Q.A And Q.C programmesRole of GMP Audits in Q.A And Q.C programmes

30.  Benefits which are derived from Audits are given
below:
Assuring GMP compliance
Detecting Potential Problems
Effecting Programme improvement
Increasing management awareness
Conti….

31.  FDA conducts routine inspections of all pharmaceutical
manufacturers to determine if manufacturing and control
procedures conform to GMPs
 FDA investigators make unannounced visits to the
manufacturing facilities to examine facilities ,
equipments, personnel and records
Assuring GMP ComplianceAssuring GMP Compliance

32.  GMP audits find objectionmable condition that is
unknown to responsible production , QC ,QA or
mangement personnel.
 The auditor will see whether such actions are frequent or
not .From this he can signal other GMP problems.
Detecting Potential ProblemsDetecting Potential Problems

33.  Changing SOPs
 Modifying maufacturing equipment or procedure
 Upgrading equipment or procedure
 Improiving emplyee training programme
 Developing new or revised documentary system
Effecting Programme ImprovementsEffecting Programme Improvements

34.  For any given audits there are two outcomes,either problems
are found or not
If the problems are found , management takes an
approprioate step to eliminate the problemn
 An audit is not finding any objectionable conditions
Either there were no problems to be found
Auditor failed to detect objectionble
condition that were actuaslly present
Increasing Management AwarenessIncreasing Management Awareness

35.  Key Elements
 i. Expectations and Philosophies
 ii. Audit Formats and Approaches
Checklist format
GMP regulation approach
System analysis methods
 iii. Checklist written criteria and Standard Operating
Procedures
 iv. Planned periodic frequency for audit
 v. Specially trained personnel
 vi. Finding Written Audit reports
Elements of a Systemic Audit ProgramElements of a Systemic Audit Program

36. Senior management establishes the fundamental
expectations of audit
 Upper level management must establish the realistic
goals and objectives
 Use of “ Formal Written Master Plan” approved by
management
Expectations and PhilosophiesExpectations and Philosophies

37. Checklist format
GMP regulation approach
 Systems analysis method
 Manual GMP audit methods can be divided in to categories
Audit Format And ApproachesAudit Format And Approaches

38.  Use checklist as GMP audit guides and reporting finding.
 Series of questions or instructions are grouped in to logical
order.
 Blocks may be used to record answer and space may be
provided to make comments.
Conti….
Checklist FormatChecklist Format

39. Advantages:-
 Simple, convenient and easy to use for any desired
subjected area
 Knowledgeable personnel may develop questions
and guideline
 Questions are in logical order that help auditor to
detect problems
 Report can be prepared in a minimum amount of
time.
Conti….
Conti….

40.  Question may be interpreted in more than one way
because of bias or hidden meaning
 Solve the devising questions is not easy task
 Limited content
The amount and type of questions that are
provided limited .
Not every issue will be covered
Each auditor must apply sound judgment when
evaluating system.
DISADVANTAGES:-
Conti….

41.  Subpart B: Organization and personnel
 Subpart C: Building and facilities
 Subpart D: Equipments
 Subpart E: Production and Processing Controls
 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
 The basic elements are derived from the following
subpart of regulations
GMP Regulation FormatGMP Regulation Format

42.  Likely to Affect the Quality Of the Product
 These FDA investigators describe the organized
method for determining of potential problem
Systemic Potential Problem AnalysisSystemic Potential Problem Analysis

43. Need to be established defining which audit data or
elements are to be considered in the assessment of
program performance
Effective use of written criteria to ensure that
conditions and practices remain under a suitable state of
control
SOPs should establish
Formal written SOPs should fully describe the details for
carrying out the various audit functions.
The responsibility for audit data review
Personnel responsible for recommendations
Decisions concerning corrective actions.
Written Criteria And SOPWritten Criteria And SOP

44. Each firm must establish the optimum time interval
between audits based on several important factors like
Intended purpose
Objectives, scope and depth
Prior history of audit finding.
Two types of visit Can be done depending on the type
of audit:-
Announced Visit
Unannounced Audit
Planned Periodic FrequencyPlanned Periodic Frequency

45. Advanced notice is given before the audit.
It is not persuasive for two reasons
Announced Visits:
The employee covers up the problem.
The person makes major adjustment in their
behavior
Benefits :-
 Audit efficiency is improved from advance
notification
 Necessary records may be organized and retrieved
in the preparation for the audit.
Key personnel become available
Conti….
Conti….

46.  To view conditions and practices that is normal or
customary (representative) as possible.
 For observing employees behavior as well as
observation of equipments and facilities.
UNANNOUNCED AUDITS
Benefits :-
Allows observation of normal condition and
practices
Conti….

47.  The following personnel factors deserve systemic attention
Defining auditor Qualification
Documentation training skills and Experience.
Selecting audit teams
Maintaining auditor awareness levels
Specially Trained PersonnelSpecially Trained Personnel

48. Selected based
On their knowledge
Experience in manufacturing and QC principles as
well as years of first hand experience dealing with
GMP matters.
Essential auditor skill is aware of
Firm’s SOPs and Knowledge
Integrated by various departments.
Defining Auditor QualificationDefining Auditor Qualification

49. Two formats
Scientific Principles
 Training under chemistry, engineering, statistical
and pharmaceutics
 GMP
GMP training may include the cumulative
knowledge from years of experience
This knowledge comes from
Daily activities
Formal training sessions
Documentation Training Skills And ExperienceDocumentation Training Skills And Experience

50.  Limitations of Personnel audit
 Experience and knowledge, which is individual.
 Emphasize on familiar issues as well as particular
area
 Team is required for cover many different systems and
large amount of data.
 Composition of team will vary depending upon the
nature and scope of the audit
Conti….
Selecting Audit teamsSelecting Audit teams

51. Leader is usually a senior auditor who has extensive
knowledge of the firm’s operations and exhibit strong
leadership qualities.
Team size depends upon
 Firm size
 Total no of products manufacturing and
control system
 Breath and depth of the audit.
 The Audit objective
Conti….

52.  Audit reports should contain complete details of the
program detected.
Corrective action is taken to eliminate problems and
to measure the overall adequacy of the audit program
uses reports.
There are two important reporting phases:-
1) Preliminary reports during the audit
2) Final report to the management
Conti….
Reporting Audit FindingReporting Audit Finding

53. Preliminary reports during the audit:
1) Benefits can be gained from having dialogues with
employees
2) Finding is communicated with affected personnel.
3) Discussion may help the employees to learn why
problems happened.
Conti….
Conti….

54. Management must review the final reports and determine
what steps need to be taken to eliminate deficiencies.
 Management should sincerely encourage detection of
problems and express appreciation for being able to improve
quality operations.
The audit reports may be shared with manger supervisor
who may discuss finding with employees.
The workers and supervisory personnel should be given the
opportunity to explain their views and ideas about the audit
findings.
Final report to the management
Conti….

55.  Pharmaceutical Dosage forms:Parenteral medication,Revised
and Expanded.Edited by Kenneth E.Avis,Herbert A.libermann
and Leon Lachmann,Volume –3, Second edition ,
Page no:-363-420
 Pharmaceutical Quality group mpnograph no:-5 (revised):
Pharmaceutical Auditing , IQA2001,ISBN 0906810 68X
 Pharmaceutical Quality assurance by Manohar A.Potdar
Nirali prakashan – page no.5.29 -5.30.
 www.google.com
 www.slideshare.com
To be
Continued………
ReferencesReferences

56. Quality asuurance And Quality management in pharmaceutical
Industry By Y.Anjaneyulu,R.Marayya,Pharma Book syndicate,
Page no:-209-218
Provisional Guideline ON the inspection of the pharmaceutical
manufacturers in: WHO Expert committee on specification for
Pharmaceutical Preparations:
32nd
report,Geneva,WHO,1992,Annex-2(Who technical report
seried. No:-823)
Conti….