Quality audit- Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team
Ähnlich wie Quality audit- Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team
Ähnlich wie Quality audit- Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team (20)
Quality audit- Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team
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
3. 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
1.Quality Audit
4. Quality audit means a systematic examination of
a quality system.
Quality audits are typically performed at defined
intervals
Any failure in their proper implementation may
be published publicly and may lead to a
revocation of quality certification
5. 2.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
6. 3.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
Conti….
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 Q.C personnel Quality control management
personnel usually prepared Periodic
evaluations
Conti….
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
4.Self Inspection
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 To be Continued………
10. 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.…
11. The quality audit system mainly classified
in three different categories:
i Internal Audits
ii. External Audits
iii. Regulatory Audits
5.Types Of Quality Audit
12. 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
i.Internal Audit
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
14. 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
Designing of the Internal Audit
System
15. 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
Implementing the Internal Audit
Program
16. EXTERNAL AUDIT
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
ii.External Audit
Conti….
17. 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
Conti….
18. Purpose of Regulatory audit:-
Networking and confidence-building between
national inspection authorities
Development of quality systems
Work towards global harmonisation of GMP
iii.Regulatory Audit
Conti….
19. 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
Conti….
20. 6.Role of GMPAudits in Q.AAnd
Q.C programmes
What is to be audited:-
Auditors review
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 in reaction to audit
finding
SOPs
Employees Practices and behaviour
Conti….
21. Assuring GMP compliance
Detecting Potential Problems
Effecting Programme
improvement
Increasing management
awareness
Benefits which are derived from Audits are
given below:
Conti….
Conti….
22. Assuring GMP Compliance
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
23. Detecting Potential Problems
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.
24. Effecting Programme
Improvements
Changing SOPs
Modifying maufacturing equipment or
procedure
Upgrading equipment or procedure
Improving employee training programme
Developing new or revised documentary system
25. 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 actually present
26. 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
7.Elements of a Systemic Audit
Program
27. 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
i.Expectations and Philosophies
28. Checklist format
GMP regulation approach
Systems analysis method
Manual GMP audit methods can be divided in
to categories
II.AUDIT FORMAT AND
APPROACHES
29. 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.
CHECKLIST FORMAT
Conti….
30. 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….
31. 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….
32. 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 Format
33. Likely to Affect the Quality Of the Product
These FDA investigators describe the
organized method for determining of
potential problem
Systemic Potential Problem
Analysis
34. 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.
iii.Written Criteria And SOP
35. 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
iv. Planned Periodic Frequency
36. 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….
37. 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….
38. The following personnel factors deserve systemic
attention
Defining auditor Qualification
Documentation training skills and Experience.
Selecting audit teams
Maintaining auditor awareness levels
v. Specially Trained Personnel
39. 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 Qualification
40. 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 Experience
41. 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
Selecting Audit teams
Conti….
42. 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….
43. 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
vi. Reporting Audit Finding
Conti….
44. 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….
45. 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….