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A Seminar On Quality Audit: M.Pharm (Quality Assurance)
A Seminar On Quality Audit: M.Pharm (Quality Assurance)
Prepared by :-
Paras Shah
Guided By :-
Mr. Dhaval Rathod
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
1.Quality Audit
Quality Audit
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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………
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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
5.Types Of Quality Audit
i Internal Audits
ii. External Audits
iii. Regulatory Audits
i.Internal Audit
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Carried out by regulatory bodies such as
MCA(U.K),USFDA(USA) for manufacturing and
supply of pharmaceutical product
Audits may be unannounced
Failure of regulatory audit
withdrawal of a manufacturing or import/export
license
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
6.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
Verify Corrective actions taken inreaction to audit
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Changing SOPs
Modifying maufacturing equipment or
procedure
Upgrading equipment or procedure
Improiving emplyee training programme
Developing new or revised documentary system
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 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
7.Elements of a Systemic Audit
Program
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
i.Expectations and Philosophies
Checklist format
GMP regulation approach
Systems analysis method
Checklist Format
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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.
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Disadvantages:-
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.
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
Systemic Potential Problem
Analysis
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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
vi. 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.
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