1. A Seminar On Quality
Audit
Prepared by :-
Heena D. Makwana
M.Pharm (Q.A Sem-1)
A.P.M.C College of pharmacy

2. Quality Audit
Quality Audit
 Quality audit is defined as a systematic and
independent examination to determine whether
activities and related results comply with
planned arrangements and whether these
arrangements are implemented effectively and
are suitable to achieve objectives

3. Objectives Of Quality Audit
 Pharmaceutical manufacturers commonly use
audits as an effective mechanism to verify
compliance with GMP regulation (GMP).GMP
audits with two important goals
 Audis are intended to verify that manufacturing and
Control systems are operating under a state of
control.
 Audits permit timely correction of potential
problems.
 Audits can be used to establish a high degree
of confidence to remain under an adequate
level of control by managements

4. Self Inspection
Principle:-
 To evaluate the manufacturer’s Compliance
with GMP in all aspects of production and
Quality control.
 Performed routinely as well as on special
occasions, e.g. in the case of product recalls
or repeated rejections

5. Items of Self inspection
 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………

6. Conti.…
 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

7. Types Of Quality Audit
The quality audit system mainly classified
in three different categories:
1. Internal Audits
2. External Audits
3. Regulatory Audits

8. Internal Audit
Purpose of Internal audit:-
 To Ensure that adequate Quality systems are
maintained
 To asses compliance with the C-GMP’s and firms
standard operating procedure
 To achieve consistency between manufacturing
and testing facilities
 To identify problems internally and Correct
problems prior to a FDA inspection

9. Designing of the Internal Audit
System
 In a pharmaceutical facility for internal
auditing, you require to check mainly two
things namely
− Activities carried out by different departments
− Documents maintained by these departments

10. Implementing the Internal Audit
Program
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 Shows corrective actions
Repeat the audit as per preplanned
Schedule

11. External Audit
External Audit
Purpose of External Audit:-
 Confidence in the partnership arrangement
 Ensuring that requirements are understood
 Reducing the risk of failure
 Carried out by company on its vendors
 No legal requirement to conduct the audit
 External audit have experience of GMP as
well as regularly audited by their certification
body

12. Regulatory Audit
Purpose of Regulatory audit:-
 Networking and confidence-building between
national inspection authorities
 Development of quality systems
 Work towards global harmonisation of GMP
Conti….

13. Conti….
 Carried out by regulatory bodies such as
MCA(U.K),USFDA(USA) for manufacturing and
supply of pharmaceutical product
 Audits may be unannounced
 After regulatory audit , a formal report will be
delivered
 For MCA:- verbal feedback report is given at
the exit meeting
For USFDA:- Provides “Form 483”is given at
the exit meeting

14. Role of GMP Audits in Q.A And
Q.C programmes
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

15.  Benefitswhich are derived from Audits are
given below:
Assuring GMP compliance
Detecting Potential Problems
Effecting
Programme
improvement
Increasing management
awareness

16. Increasing Management
Awareness
 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 problem
 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

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

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

19. Checklist Format
 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.

20. GMP Regulation Format
 The basic elements are derived from the
following subpart of regulations
 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

21. Written Criteria And SOP
Formal written SOPs should fully describe the
details for carrying out the various audit functions.
Effective use of written criteria to ensure that
conditions and practices remain under a suitable
state of control
SOPs should establish
The responsibility for audit data review
Personnel responsible for recommendations
Decisions concerning corrective actions.

22. Planned Periodic Frequency
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:-
AnnouncedVisit
Unannounced Audit

23. Conti….
Announced Visits:
Advanced notice is given before the audit.
It is not persuasive for two reasons
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….

24. Conti….
Unannounced Audits
 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.
Benefits :-
 Allows observation of normal condition
and practices

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

26. Defining Auditor Qualification
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.

27. Documentation Training Skills
And Experience
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

28. Selecting Audit teams
 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….

29. Conti….
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

30. Reporting Audit Finding
 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

31. References
 PharmaceuticalDosage 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
 QualityManual, D. H. Shah, First edition,
Page no:- 184-216