Quality audit slideshare
- 2. ASeminaronQualityAuditASeminaronQualityAudit Prepared by :- Miss.Chaitrali Gole Prepared by :- Miss.Chaitrali Gole M.Pharm Semester first (Quality assurance) M.Pharm Semester first (Quality assurance)
- 3. Definition Self inspection Types of Quality Audit Objectives Role OF GMP Audit in QA and QC programmes Elements of a Systemic Audit Program ContentsContents
- 7. 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 InspectionSelf Inspection
- 8. 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……… Items of Self inspectionItems of Self inspection
- 9. 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.…
- 29. 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 finding To be Continued……… Role of GMP Audits in Q.A And Q.C programmesRole of GMP Audits in Q.A And Q.C programmes
- 30. Benefits which are derived from Audits are given below: Assuring GMP compliance Detecting Potential Problems Effecting Programme improvement Increasing management awareness Conti….
- 31. 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 Assuring GMP ComplianceAssuring GMP Compliance
- 32. 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. Detecting Potential ProblemsDetecting Potential Problems
- 33. Changing SOPs Modifying maufacturing equipment or procedure Upgrading equipment or procedure Improiving emplyee training programme Developing new or revised documentary system Effecting Programme ImprovementsEffecting Programme Improvements
- 34. 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 Increasing Management AwarenessIncreasing Management Awareness
- 35. 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 Elements of a Systemic Audit ProgramElements of a Systemic Audit Program
- 36. 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 PhilosophiesExpectations and Philosophies
- 37. Checklist format GMP regulation approach Systems analysis method Manual GMP audit methods can be divided in to categories Audit Format And ApproachesAudit Format And Approaches
- 38. 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. Conti…. Checklist FormatChecklist Format
- 39. 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….
- 40. 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….
- 41. 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 FormatGMP Regulation Format
- 42. Likely to Affect the Quality Of the Product These FDA investigators describe the organized method for determining of potential problem Systemic Potential Problem AnalysisSystemic Potential Problem Analysis
- 43. 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. Written Criteria And SOPWritten Criteria And SOP
- 44. 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 FrequencyPlanned Periodic Frequency
- 45. 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….
- 46. 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….
- 47. The following personnel factors deserve systemic attention Defining auditor Qualification Documentation training skills and Experience. Selecting audit teams Maintaining auditor awareness levels Specially Trained PersonnelSpecially Trained Personnel
- 48. 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 QualificationDefining Auditor Qualification
- 49. 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 ExperienceDocumentation Training Skills And Experience
- 50. 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 Conti…. Selecting Audit teamsSelecting Audit teams
- 51. 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….
- 52. 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 Conti…. Reporting Audit FindingReporting Audit Finding
- 53. 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….
- 54. 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….
- 55. 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 Pharmaceutical Quality assurance by Manohar A.Potdar Nirali prakashan – page no.5.29 -5.30. www.google.com www.slideshare.com To be Continued……… ReferencesReferences
- 56. 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: 32nd report,Geneva,WHO,1992,Annex-2(Who technical report seried. No:-823) Conti….