logging in or signing up Quality audit vinay13 Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: Embed: Flash iPad Copy Does not support media & animations WordPress Embed Customize Embed URL: Copy Thumbnail: Copy The presentation is successfully added In Your Favorites. Views: 2975 Category: Science & Tech.. License: All Rights Reserved Like it (0) Dislike it (0) Added: July 16, 2011 This Presentation is Public Favorites: 6 Presentation Description No description available. Comments Posting comment... By: mytis (19 month(s) ago) pls allow me to download. i m in need of this..pls Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript Slide 1: PRAJAPATI VINAY. M.pharm-1(Q.A) S.J.THAKKAR PHARMACY COLLEGE, RAJKOT. Prepared by :- A Seminar On Quality Audit 1Slide 2: Definition Objectives Self inspection Types of Quality Audit Role OF GMP Audit in QA and QC programmes Elements of a Systemic Audit program Summary 2 CONTENTSSlide 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 3Slide 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 4 Conti.…Slide 5: 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 5 OBJECTIVES OF QUALITY AUDIT: 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 6 SELF INSPECTIONSlide 7: 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……… 7 ITEMS OF SELF INSPECTIONSlide 8: 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.… 8Slide 9: The quality audit system mainly classified in three different categories : 9 TYPES OF QUALITY AUDITSlide 10: 10 Carried Out by:-Slide 11: 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 11 INTERNAL AUDITSlide 12: 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 12 DESIGNING OF THE INTERNAL AUDIT SYSTEMSlide 13: 13 IMPLEMENTING THE INTERNAL AUDIT PROGRAMSlide 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 Conti…. 14 EXTERNAL AUDIT: Carried Out by a company on its vendors or sub contractors No legal requirement for to conduct audit Regular audits will be carried out to assesses compliance with agreed standards Increase confidence in vendor auditing Reduce level of external auditing External auditors have experience of GMP and as well as regularly audited by their certification body Conti…. 15Slide 16: Purpose of Regulatory audit:- Networking and confidence-building between national inspection authorities Development of quality systems Work towards global harmonization of GMP Conti…. 16 REGULATORY AUDITSlide 17: 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…. 17Slide 18: What is to be audited:- Auditors review SOPs Employees Practices and behavior Compare master specifications against compendia 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 Conti…. 18 ROLE OF GMP AUDITS IN Q.A AND Q.C PROGRAMMESSlide 19: Assuring GMP compliance Detecting Potential Problems Effecting Programmed improvement Increasing management awareness Benefits which are derived from Audits are given below: Conti…. Conti…. 19Slide 20: FDA conducts routine inspections of all pharmaceutical manufacturers to determine if manufacturing and control procedures conform to GMP FDA investigators malke unannounced visits to the manufacturing facilities to excamine facilities , equipments, personnel and records Use systemic analysis approach 20 ASSURING GMP COMPLIANCESlide 21: DETECTING POTENTIAL PROBLEMS GMP audits find objectionmable 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. 21Slide 22: EFFECTING PROGRAMME IMPROVEMENTS Changing SOPs Modifying manufacturing equipment or procedure Upgrading equipment or procedure Improving employee training programmed Developing new or revised documentary system 22Slide 23: 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 problem An audit is not finding any objectionable conditions Either there were no problems to be found Auditor failed to detect objectionable condition that were actually present 23Slide 24: Key Elements Expectations and Philosophies Audit Formats and Approaches Checklist form 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 ELEMENTS OF A SYSTEMIC AUDIT PROGRAM 24Slide 25: 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 EXPECTATIONS AND PHILOSOPHIES 25AUDIT FORMAT AND APPROACHES: Manual GMP audit methods can be divided in to categories AUDIT FORMAT AND APPROACHES 26CHECKLIST 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. CHECKLIST FORMAT Conti…. 27Slide 28: 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…. 28Disadvantages:-: 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…. 29Slide 30: 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 30Slide 31: Likely to Affect the Quality Of the Product These FDA investigators describe the organized method for determining of potential problem SYSTEMIC POTENTIAL PROBLEM ANALYSIS 31Slide 32: Need to be established defining which audit data or elements are to be considered in the assessment of program performance Formal written SOPs should fully describe the details for carrying out the various audit functions . The responsibility for audit data review Personnel responsible for recommendation Decisions concerning corrective actions. Effective use of written criteria to ensure that conditions and practices remain under a suitable state of control SOPs should establish WRITTEN CRITERIA AND SOP 32Slide 33: 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 PLANNED PERIODIC FREQUENCY 33Slide 34: 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…. 34 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. Unannounced Audits Benefits :- Allows observation of normal condition and practices Conti…. 35Slide 36: The following personnel factors deserve systemic attention Defining auditor Qualification Documentation training skills and Experience. Selecting audit teams Maintaining auditor awareness levels SPECIALLY TRAINED PERSONNEL 36Slide 37: 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 37Slide 38: 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 38Slide 39: 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…. 39Slide 40: 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…. 40Slide 41: 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:- Preliminary reports during the audit Final report to the management REPORTING AUDIT FINDING Conti…. 41Slide 42: Preliminary reports during the audit: Benefits can be gained from having dialogues with employees Finding is communicated with affected personnel. Discussion may help the employees to learn why problems happened. Conti…. Conti…. 42Slide 43: 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…. 43Slide 44: SELF AUDIT QUESTIONS Does the company have a written self inspection procedures calling for self inspection at regular intervals? Does the procedure specify a designated expert or a team of experts to conduct regularly scheduled inspections? Does the self inspection schedule cover ail aspects of production? Does the self inspection schedule cover all aspects of quality control/quality assurance/ Does the self inspection schedule cover all aspects of the quality control laboratory? Is the follow-up action recorded? 44Slide 45: Nobody likes to be audited……….. It is a means to have continuous improvement. Thank You 45 You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.