AUDIT ppt by RAVI

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A SEMINAR ON GMP AND QUALITY AUDIT:

Presented by V . Ravi Under the guidance of B.Chandrasekhar Rao (M.Pham) Department of pharmaceutics SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS A SEMINAR ON GMP AND QUALITY AUDIT 1 3/26/2012 SSJ COLLEGE OF PHARMACY e-mail: Pharmaravi.2011@gmail.com

Contents :

Contents Introduction Definition Objectives Self Inspection Types of Quality Audit Role of GMP Audit in QA and QC programs Elements of a Systemic Audit Program Conclusion References SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 2 3/26/2012

QUALITY AUDIT :

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 achieves SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS Conti… 3 3/26/2012

Quality audit means a systematic examination of a quality system. :

Quality audit means a systematic examination of a quality system. SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 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 Conti… QUALITY AUDIT 4 3/26/2012

OBJECTIVES OF QUALITY AUDIT :

OBJECTIVES OF QUALITY AUDIT Pharmaceutical manufacturers commonly use audits an effective mechanism to verify compliance with GMP regulation . GMP audits with two important goals Audits 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 a adequate level of managements. SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 5 3/26/2012

SELF INSPECTION:

SELF INSPECTION Principle:- To evaluate the manufacturer´s compliance with GMP in all aspects of production and Quality control. Designed to detect any shortcoming 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. SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 6 3/26/2012

ITEMS OF SELF INSPECTION:

ITEMS OF SELF INSPECTION Personnel Premises including personnel facilities Maintenance of building and equipments Storage of starting materials and finished products Equipments Production and in-process controls Quality control Documentation SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS Conti…. 7 3/26/2012

Conti….:

Conti…. Sanitation and hygiene Validation and revalidation programs Calibration of instruments or measurements Systems Recall procedures Complaints managements Labels control Results of previous self-inspections and any corrective steps taken. SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS ITEMS OF SELF INSPECTION 8 3/26/2012

TYPES OF QUALITY AUDIT :

TYPES OF QUALITY AUDIT The quality audit systems mainly classified in three different categories:- SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 9 3/26/2012

Carried out by:-:

Carried out by:- SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 10 3/26/2012

INTERNAL AUDIT:

INTERNAL AUDIT To ensure that adequate quality systems are maintained To ensure 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. SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 11 3/26/2012

DESIGNING OF INTERNAL AUDIT SYSTEM:

DESIGNING OF INTERNAL AUDIT SYSTEM 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 SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 12 3/26/2012

IMPLIMNTATING THE INTERNAL AUDIT PROGRAM:

IMPLIMNTATING THE INTERNAL AUDIT PROGRAM SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 13 3/26/2012

EXTERNAL AUDIT:

EXTERNAL AUDIT Purpose of external auditing:- Confidence in the partnership arrangements Ensuring that requirements are understood Enabling reduction of sting QC test of starting materials Reducing the risk of failure Carried out by a company on its vendors or sub contractors No legal requirement for to conduct audit SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 14 3/26/2012

PowerPoint Presentation:

Regular audits will be carried carried out to assess 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 SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS Conti…. 15 3/26/2012

REGULATORY AUDIT:

REGULATORY AUDIT Purpose of regulatory audit:- Networking and confidence –building between national inspection authorities Development of quality systems Work towards global harmonization o f GMP Carried out by regulatory bodies such as MCA (U.K),USFDA (USA) for manufacturing and supply of pharmaceutical product SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 16 3/26/2012

Conti…:

Conti… 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 USDA:- Provides form 483 is given at the exit meeting SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 17 3/26/2012

ROLE OF GMP AUDIT IN Q.A AND Q.C PROGRAMES:

ROLE OF GMP AUDIT IN Q.A AND Q.C PROGRAMES What is to be audited:- Auditors review SOPs Employee 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 incretion to audit finding conti.. SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 18 3/26/2012

Benefits which are derived from audits are given below::

Benefits which are derived from audits are given below: Assuring GMP compliance Detecting potential problems Effecting programmed improvement Increasing management awareness SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 19 3/26/2012

ASSURING GMP COMPLIANCE:

ASSURING GMP COMPLIANCE FDA conducts routine inspections of all pharmaceutical manufacturers to determine if manufacturing and control procedures conform to GMP FDA investigators make unannounced visits to the manufacturing facilities to examine facilities, equipments, personnel and records Use systemic analysis approach SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 20 3/26/2012

DETECTING POTENTIAL PROBLEMS:

DETECTING POTENTIAL PROBLEMS GMP audits find objectionable condition that is unknown to responsible production, QC,QA or management personnel. The auditors will see whether such actions are frequent or not. For these he can signal other GMP problems. SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 21 3/26/2012

EFFECTING PROGRAMME IMPROVEMENTS:

EFFECTING PROGRAMME IMPROVEMENTS Changing SOPs Modifying manufacturing equipment or procedure Upgrading equipment or procedure Improving employee training programmed Developing new or revised documentary system SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 22 3/26/2012

INCEREASING MANAGEMENT AWARNESSS:

INCEREASING MANAGEMENT AWARNESSS 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 SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 23 3/26/2012

ELEMENTS OF SYSTEMIC AUDIT PROGRAM:

ELEMENTS OF SYSTEMIC AUDIT PROGRAM Key elements Expectations and Philosophies Audit formats and Approaches checklist form GMP regulation approach Systemic analysis methods Checklist written criteria and standard operating procedure s Planed periodic frequency for audit Specially trained personnel Finding written audit reports SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 24 3/26/2012

EXPECTATIONS AND PHILOSOPHIES:

EXPECTATIONS AND PHILOSOPHIES Seminar 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 SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 25 3/26/2012

AUDIT FORMAT AND APPROACHES:

AUDIT FORMAT AND APPROACHES Manual GMP audit methods can be divided in to categories SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 26 3/26/2012

CHECKLIST FORMAT :

CHECKLIST 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. Simple, convenient and easy to use for any desired subjected area. SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 27 3/26/2012

Advantages:-:

Advantages:- Knowledgeable personnel may develop questions and quidline Questions are in logical order that help auditor to detect problems Report can be prepared in a minimum amount of time. SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 28 3/26/2012

Disadvantages:

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 SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 29 3/26/2012

GMP REGULATION FORMAT:

GMP REGULATION FORMAT The basic element s 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 SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 30 3/26/2012

SYSTEMIC POTENTIAL PROBLEM ANALYSIS:

SYSTEMIC POTENTIAL PROBLEM ANALYSIS Likely to Affect the Quality Of the Production These FDA investigators describe the organized method for determining of potential problem SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 31 3/26/2012

WRITTEN CRITERIA AND SOP:

WRITTEN CRITERIA AND SOP 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. SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 32 3/26/2012

PLANNED PERIODIC FREQUENCY:

PLANNED PERIODIC FREQUENCY 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 SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 33 3/26/2012

Announced Visits::

Announced Visits: Advanced notice is given before the audit. It is not persuasive for two reasons 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 presentation for the audit. Key personnel become available SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 34 3/26/2012

Unannounced audits:

Unannounced audits To view conditions and practices that is normal or customary (representative) as possible. For observation employee behavior as observation of equipments and facilities. Benefits :- Allows observation of normal condition and practices SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 35 3/26/2012

SPECILLY TRAINED PERSONNELS :

SPECILLY TRAINED PERSONNELS The following personnel factors deserve systemic attention Defining auditor Qualification Documentation training skills and Experience. Selecting audit teams Maintaining auditor awareness levels SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 36 3/26/2012

DEFINING AUDITOR QUALIFICATION:

DEFINING AUDITOR QUALIFICATION 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. SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 37 3/26/2012

DOCUMENTATION TRAINING SKILLS AND EXPERIENCE:

DOCUMENTATION TRAINING SKILLS AND EXPERIENCE Two formats Scientific Principles Training under chemistry, engineering, sta tistical and pharmaceuticals GMP GMP training may include the cumulative knowledge from years of experience This knowledge comes from Daily activities Formal training sessions SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 38 3/26/2012

SELECTING AUDIT TEAM:

SELECTING AUDIT TEAM Limitations of personal 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 SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS Conti… 39 3/26/2012

Conti…:

Leader is usually a senior author who has extensive knowledge of the firms 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 SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS Conti… 40 3/26/2012

REPORTING AUDIT FINDING:

REPORTING AUDIT FINDING Audit report 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 SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 41 3/26/2012

Preliminary reports during the audit :

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 appended. SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 42 3/26/2012

Final report to the management :

Final report to the management 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 manager supervisor who may discourse finding with employees. SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 43 3/26/2012

SELF AUDIT QUESTIONS:

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 fellow-up action recorded? SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 44 3/26/2012

Conclusion:

Conclusion I hereby conclude that Audit potentially identifies the problems in implementation of quality standards in an organization. The organization should always be ‘AUDIT READY’ and the key success during an audit is preparation. 3/26/2012 SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 45

REFERENCES: :

REFERENCES: Quality assurance and quality management in pharmaceutical industry :Y.Anjaneyulu and R.Marayya.vol,2:34-48 www.complianceonline.com www.auditnet.org http://policy.ballarat.edu.au/planning_quality_review/internal_quality_audits/ch01.php www.fda.gov www.fdinspection.com VZ.TPR.9453: © Verizon 2008:8-10 www.authorstream.com 3/26/2012 SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 46

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THANKYOU SSJ COLLEGE OF PHARMACY - DEPARTMENT OF ANALYSIS 47 3/26/2012

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