a seminar on quality audit m.pharm (quality assurance) prepared by :- paras shah guided by :- mr....
TRANSCRIPT
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
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
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
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
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
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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
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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
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………
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
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The quality audit system mainly classified in three different categories:
i Internal Audits ii. External Audits iii. Regulatory Audits
5.Types Of Quality 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
i.Internal Audit
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
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
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
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
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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
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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
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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
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6.Role of GMP Audits in Q.A And 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 inreaction to audit
finding
SOPsEmployees Pracices and behaviour
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Assuring GMP compliance
Detecting Potential Problems
Effecting Programme improvement
Increasing management awareness
Benefits which are derived from Audits are given below:
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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
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.
Effecting Programme Improvements
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
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
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
Checklist format
GMP regulation approach
Systems analysis method
Manual GMP audit methods can be divided in to categories
ii.Audit Format And Approaches
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
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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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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….
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
Likely to Affect the Quality Of the Product
These FDA investigators describe the organized method for determining of potential problem
Systemic Potential Problem Analysis
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 reviewPersonnel responsible for recommendationsDecisions concerning corrective actions.
iii.Written Criteria And SOP
Each firm must establish the optimum time interval between audits based on several important factors like
Intended purposeObjectives, scope and depthPrior history of audit finding.
Two types of visit Can be done depending on the type of audit:-
Announced VisitUnannounced Audit
iv. Planned Periodic Frequency
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
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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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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
Selected based
On their knowledgeExperience 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
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
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
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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
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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 audit2) Final report to the management
vi. Reporting Audit Finding
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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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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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References
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
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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: 32ndreport,Geneva,WHO,1992,Annex-2(Who technical report seried. No:-823)
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