This document discusses quality audits in the pharmaceutical industry. It defines quality audits and differentiates them from periodic evaluations. The objectives of quality audits are to verify compliance with Good Manufacturing Practices (GMP) regulations and allow for timely correction of problems. The document describes different types of audits, including internal audits, external audits, and regulatory audits. It also outlines the key elements of a quality audit program, such as using checklists, training auditors, documenting findings in reports, and having management review and address any issues.

1. QUALITY AUDITS
Dr. V. S. Kashikar
Asso. Prof., Head, Dept. of Pharmaceutics
PES Modern College of Pharmacy ( for ladies), Moshi Pune 412 105
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2. Contents
 Definition
 Objectives
 Difference between Quality audit and Periodic
evaluation
 Self inspection
 Types of Quality Audit
 Role OF GMP Audit in QA and QC programmes
 Elements of a Systemic Audit program
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3.  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 .
 Quality audit means a systematic examination of
a quality system
 Quality audits are typically performed at defined
intervals
What is quality audit
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4.  A quality audit is an examination of all or part of
quality system with specific aim of improving it.
 Usually conducted by outside experts or team
appointed by management
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5. Objectives of Quality Audit
• Pharmaceutical manufacturers commonly use audits as
an effective mechanism to verify compliance with GMP
regulation. GMP audits with two important goals
 Audits 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 .
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6. Difference between Audit and
Periodic Evaluation
Quality audit Periodic Evaluation
Quality audit is Periodic, independent,
and documented examination and
verification of activities, records,
processes, and other elements of a
quality system to determine their
conformity with the requirements of a
quality standard such as GMP
Periodic evaluations are routine
reviews and assessments of the
quality standards of each drug
product that are made to determine
the need for changes in drug product
specifications or manufacturing or
control procedures
 Auditors should not have direct
responsibilities for the operations
they review
Employees who are directly
responsible for system under review
normally perform periodic evaluations
 Audit is the function of Quality
assurance
 Periodic evaluation is a function of
Quality control department
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7. Quality audit Periodic Evaluation
 To verify on a regular basis that a
firms procedures and practices are in
conformity with established SOPs and
applicable GMPs
 Periodic Evaluation determine the
need for change in product,
specification or control procedures
and implement it if necessary
 Auditors reviewed Sops, Employee
practices And behavior to see how
well they follow established SOPs
It plays a primary role in Day-to-
Day decision-making process used
by QC unit
Report is prepared by QC personnel  Quality control management
personnel usually prepared Periodic
evaluations
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8. 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 Inspection
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9. 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
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10.  Documentation
 Sanitation and hygiene
 Validation and revalidation programmes
 Calibration of instruments or measurement
 Recall procedures
 Complaints management
 Labels control
 Results of previous self-inspections and any
corrective steps taken
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11. The quality audit system mainly classified in three
different categories:
1. Internal Audits
2. External Audits
3. Regulatory Audits
Types of Quality Audit
1. Internal audit :
 Purpose of Internal audit: To Ensure that
adequate Quality systems are maintained
 To asses compliance with the cGMP’s and firms
standard operating procedure
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12.  To achieve consistency between manufacturing
and testing facilities
 To identify problems internally and Correct
problems prior to a FDA inspection
Types of internal audit :
1. Tier one
2. Tier two
3. Tier three
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13. Tier One Tier Two Tier Three
Carried out:- Staff of a section
or department of
company
Local Quality
assurance Group
Corporate
Compliance Group
And External
Consultant
Purpose:- Require Short time
and Focusing on
house keeping and
documentation
Require Longer
period and more
focus on system
than housekeeping
More focusing for
asses the readiness
of regulatory audit
Frequency:- More Less Less than tier two
Qualification:- Receive Some
basic training
More exclusive
training
Highly trained and
experienced or
specialist with the
expert knowledge
of GMP
Types of Internal Audit
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14. Purpose of External Audit:-
 Confidence in the partnership arrangement
 Ensuring that requirements are understood
 Enabling reduction of in-house QC testing of
starting materials
 Reducing the risk of failure Carried Out by a
company on its vendors or sub contractors
 No legal requirement for to conduct audit
 External auditors have experience of GMP and
as well as regularly audited by their
certification body
2. External audit
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15. Purpose of Regulatory audit:-
 Networking and confidence-building between national
inspection authorities
 Development of quality systems
 Work towards global harmonization of GMP Carried out by
regulatory bodies such as MCA(U.K),USFDA(USA) for
manufacturing and supply of pharmaceutical product
 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
3. Regulatory audit
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16. Role of GMPAudits in Q.AAnd Q.C
programmes
What is to be audited:-
 Compare master specifications against
regulatory requirements
 Verify the test data and validation testing
 Validation test reports are compared against raw
data
 Verify Corrective actions taken in reaction to audit
finding
SOPs
Employees Pracices and behaviour
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17. 1. Assuring GMP compliance
2. Detecting Potential Problems
3. Effecting Programme improvement
4. Increasing management awareness
Benefits which are derived from Audits are
given below
1.Assuring GMP Compliance :
FDA conducts routine inspections of all
pharmaceutical manufacturers to determine if
manufacturing and control procedures conform to
GMPs .
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18.  FDA investigators make unannounced visits to
the manufacturing facilities to examine facilities
equipments, personnel and records
2. Detecting Potential Problems :
• GMP audits find objectionable condition that is
unknown to responsible production, QC,QA or
management personnel.
• The auditor will see whether such actions are
frequent or not. From this he can signal other
GMP problems.
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19. 3.Effecting Programme Improvements :
• Changing SOPs
• Modifying manufacturing equipment or
procedure
• Upgrading equipment or procedure
• Improving employee training programme
• Developing new or revised documentary system
4.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 appropriate step to eliminate the problems
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20. An audit is not finding any objectionable
conditions
Either there were no problems to be found
Auditor failed to detect objectionble
condition that were actually present
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21.  Key Elements
1. Audit Formats and Approaches
a.Checklist format
b.GMP regulation approach
c.System analysis methods
2.Checklist written criteria and Standard
operating Procedures
3. Planned periodic frequency for audit
4.Specially trained personnel
5. Finding Written Audit reports
Elements of a Systemic Audit Program
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22. 1. Checklist format
2. GMP regulation approach
3. Systems analysis method
Manual GMP audit methods can be divided in to
categories
1.Audit Format And Approaches
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23. • 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.
• Advantages:-
 Simple, convenient and easy to use for any
desired subjected area
 Report can be prepared in a minimum amount of
time.
a. Checklist Format
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24.  Question may be interpreted in more than one
way because of 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
• Disadvantages:-
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25. • 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
b.GMP Regulation Format
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26.  Likely to Affect the Quality of the Product
 These FDA investigators describe the
organized method for determining of
potential problem
c. Systemic Potential Problem Analysis
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27. •Effective use of written criteria to ensure that
conditions and practices remain under a suitable
state of control
• Formal written SOPs should fully describe the
details for carrying out the various audit functions.
2.Written Criteria And SOP
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28. 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
3.Planned Periodic Frequency
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29.  Advanced notice is given before the audit.
Announced Visits:
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
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30.  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
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31.  The following personnel factors deserve systemic
attention
• Defining auditor Qualification
• Documentation training skills and Experience.
• Selecting audit teams
• Maintaining auditor awareness levels
4. Specially Trained Personnel
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32. Selected based
• On their knowledge
• Experience in manufacturing and QC principles as
well as experience dealing with GMP matters.
Defining Auditor Qualification
Documentation Training Skills and Experience
• Training under Chemistry, Engineering, Statistical
and Pharmaceutics
• GMP training may include the cumulative
knowledge from years of experience
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33. • 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
 Selecting Audit teams
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34. • 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
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35. • 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
5.Reporting Audit Finding
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36. 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.
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37. • 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
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38. Thank you
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