Quality audit and self inspection

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SELF-INSPECTION AND QUALITY AUDIT:

SELF-INSPECTION AND QUALITY AUDIT Presented by : Aashka Jani , Asst. Professor Department of pharmaceutical Science, Saurashtra University

PowerPoint Presentation:

The International Standards Organisation (ISO) has defined a QUALITY AUDIT as: “ A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements , and whether these arrangements are implemented effectively and are suitable to achieve objectives ” SELF INSPECTION consists of a periodic detailed examination of conditions and working procedures by a team from the production site, with the aim of verifying that good pharmaceutical manufacturing practices are being applied and to propose any necessary corrective measures to responsible management.

PowerPoint Presentation:

Another defination ; A QUALITY AUDIT consists of an examination and an evaluation of all or part of a system of quality assurance. It must be carried out by a specialist or a team designated for this purpose. It may be extended, as necessary, to suppliers and sub-contractors.

BASIC TYPES:

BASIC TYPES QUALITY AUDITS: BASIC TYPES 1. Imposed upon manufacturer or supplier a. Regulatory b. Customer, or potential customer c. Third party (on behalf of customer) 2. Performed by manufacturer a. Internal (i.e., self-inspection) i . Overall ii. Departmental iii. Product-orientated iv. System-orientated

BASIC TYPES:

BASIC TYPES QUALITY AUDITS: BASIC TYPES b. External, e.g.: i . Of supplier ii. Of contract manufacturer iii. Of contract packager iv. Of contract warehouse/distributor

Self-Inspection:

Self-Inspection Principle: Self-inspections should be conducted in order to monitor the implementation and the respect of Good Manufacturing Practice (GMP) principles and to propose necessary corrective measures. Personnel matters, premises, Equipment, documentation, production, distribution of the medicinal products, arrangements for dealing with complaints and recalls, and self-inspection, should be examined at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance.

Self-Inspection:

Self-Inspection Self-inspections should be conducted in an independent and detailed way by designated competent person(s) from the company. Independent audits by external experts may also be useful. All self-inspections should be recorded. Reports should contain all the observations made during the inspections and, where applicable, proposals for corrective measures. Statements on the actions subsequently taken should also be recorded.

Reasons for Quality Auditing:

Reasons for Quality Auditing 1. Internal Audit — in order to: Determine the level of compliance Build confidence in GMP and the QA system Build interdepartmental trust, understanding, and communication (if the audit is done properly and tactfully) Determine measures necessary to improve, e.g.,: Premises, equipment, environment Operations, actions, procedures Personnel/training

Reasons for Quality Auditing:

Reasons for Quality Auditing 1. Internal Audit — in order to: Provide a stimulus for improvement Recommend corrective action Monitor improvement

Reasons for Quality Auditing:

Reasons for Quality Auditing 2. External Audit — in order to: Establish and monitor capability of supplier or contractor to deliver goods and services that are fit for purpose (and on time, and in the quantity required) Build mutual confidence Promote understanding and communication between the parties involved

STEPS TO PERFORMING A QUALITY AUDIT:

STEPS TO PERFORMING A QUALITY AUDIT Plan and prepare Arrange and announce Arrive at site of audit, meet, explain purpose Perform audit Informal oral report of finding Formal report, with recommendations Follow-up

The Tools Of The Auditor:

The Tools Of The Auditor 1. Documents Quality and GMP regulations, standards, and guidelines (local, national, and international) Previous audit and follow-up reports Auditee’s own documents and records Audit checklists 2. The auditors own eyes, ears, brain, words, character, etc. 3. The auditing plan 4. paper, pen or pencil, and so on

Quality regulations, standards, and guidelines :

Quality regulations, standards, and guidelines 1. LOCAL (or corporate), e.g.,: Audited company’s own internal regulations, and guidelines Their quality manual (if one exists) Their site master file (if one exists) 2. NATIONAL, e.g.,: US cGMPs (and relevant FDA compliance guidelines) UK Medicines Act and Regulations UK Orange Guide (medicinal products)

Quality regulations, standards, and guidelines :

Quality regulations, standards, and guidelines 3. INTERNATIONAL,e.g .,: ISO Standards (including the 9000 Series) WHO GMP Guide EC (EU) GMP Directive (91/356) EC (EU) GMP Guide PIC GMP Guide (guide for good manufacturing practice for medicinal products )

The Auditor:

The Auditor In the achievement of the objectives of an audit, and to ensure that it is well and effectively conducted, the most important of the tools listed above is the auditor himself — and his eyes, ears, brain, character, and communication skills. The essential qualities of a good auditor are: Appropriate range and depth of knowledge, both of QA/GMP and of the relevant technology Range and depth of relevant experience Good powers of observation An enquiring, yet open mind Able to think on feet (to have the ability to think quickly under pressure/stressful situations)

The Auditor:

The Auditor Articulate — good communication skills “Unflappability” — able to stay cool Able to take a constructive approach Able to make sound judgments on the matters observed Able to be persistent , yet patient and diplomatic, in pursuit of the objectives of the audit Able to listen In good health

The Auditor:

The Auditor It is important for an auditor to understand that there may be ways for a manufacturer to achieve the desired quality objectives, other than those with which he or she (the auditor) is familiar The auditor should be prepared to listen patiently and sympathetically to explanations offered , and to make a sound, open-minded judgment on the validity of those explanations

The Auditor:

The Auditor Whatever happens, he or she must be able to stay calm , and not enter into contentious argument Quality auditing can be both mentally and physically demanding. It is not a job for the unfit.

Audit Planning And Preparation:

Audit Planning And Preparation the success (or failure) of an audit in achieving its objectives greatly depends on the quality of the advance planning and preparation. It is vital that all concerned are aware of the type and objectives, and the date and time, of the audit and of the areas and systems to be covered. If the audit is to be performed by a team, then the team leader or lead spokesperson should be decided in advance.

Audit Planning And Preparation:

Audit Planning And Preparation It is important to learn as much as possible about the site or area to be audited, in advance following Audit Preparation Checklist may be set down: Agree date and time of audit Clarify and communicate objectives and the standard, regulation , or guideline against which audit will be performed Decide type of audit and auditing strategy

Audit Planning And Preparation:

Audit Planning And Preparation Define areas or systems to be covered Inform auditee Obtain and review details of site or area to be audited, e.g.: Site or area plans or drawings Personnel organization charts Products manufactured Quality Manual, or Site Master File (if available) Any available records of complaints and recalls Any reports of previous audits and follow-up records Prepare a structure for note taking, or devise a checklist Hold final team briefing meeting

Auditing Strategies:

Auditing Strategies A number of different possible approaches to conducting an audit, or audit strategies have been proposed These may be summarized as follows: Forward trace — i.e., following production flow from receipt of components or materials through to dispatch of finished products Backward trace — i.e., the reverse of the above Product-orientated

Auditing Strategies:

Auditing Strategies Documentation-based Problem-orientated (e.g., centred around complaints or recalls, and any corrective action taken) System-based Completely random

Auditing Strategies:

Auditing Strategies By far the most common, and most simple and logical , approach is the first ( forward trace ). It can be applied to an entire manufacturing site or to a single department. There is absolutely no merit in a completely random approach. A product-orientated approach is a perfectly viable option. Here, the focus is on just one product , or family of similar products.

Auditing Strategies:

Auditing Strategies It leads to an intense, in depth concentration on the manufacture of just that one product An audit can be documentation-based, as tends to be favored by the FDA Such an approach is easy on the feet, but of limited value in terms of getting to grips with the whole quality picture.

Arriving And Starting:

Arriving And Starting auditors arrive at the site or the department to be audited. They should arrive: On time Well organized Well prepared They should aim to look smart in appearance , with a well-mannered, professional style and approach that is sensitive to the thoughts, feelings , attitudes, procedures, safety and security requirements, and indeed the “culture,” of the people to be audited.

The Opening Meeting:

The Opening Meeting A suggested agenda for this meeting is: Introductions Auditors explain purpose and objectives Meet those who will be escorting the auditors and responding to their questions Auditors inquire of company rules, work practices Agree programming/timing

Audit Observations:

Audit Observations General company information: The basic general information that auditors need to have, or acquire, includes Where is the plant location and what is the immediately surrounding environment? Are the factory surrounds kept neat, clean, or tidy ? (Such things may not directly affect product quality, but scruffy grounds are indicative of a poor attitude.) Are there any undesirable activities ( sewage works , rubbish tips, etc.) going on in the immediate vicinity? How is the company managed?

Audit Observations:

Audit Observations General company information: Is there a clear and explicit chain of command, made clear in organization chart(s), with written job descriptions for supervisory and management positions? What is the company’s training policy , and how is it implemented, programmed, and recorded, both in relation to induction and continuing training? From where does the company obtain its starting and packaging materials?

Audit Observations:

Audit Observations General company information: Does it use contractors to manufacture or supply any of its products, or to provide any services (analytical, engineering or maintenance)? Does it provide, under contract, any goods or services to other organizations?

Audit Observations:

Audit Observations 2. Departmental conditions and practices : Most medicinal and other healthcare products are manufactured in a series of different stages in different departments or sections. Some of the things that auditors need to note are common to all (or most) departments and sections, for example, security, cleanliness good order the physical measures taken to avoid cross-contamination and mix-up, the availability of written procedures, whether or not these are being followed.

Audit Observations:

Audit Observations 2. Departmental conditions and practices : Other departmental points to be noted will be specific to the work of a given department or section — stores, tablet or capsule manufacture, sterile products, packaging, testing laboratory, or whatever. Here, the auditor’s knowledge and understanding of the relevant science, technology, and techniques is crucial. The auditor should probe the interfaces between departments and attempt to evaluate how the things that one department does, or produces, impact the others.

Audit Observations:

Audit Observations 3. Systems: The systems that should be examined include: Quality system (of course) Overall documentation and document control Change control systems HVAC (Heating, ventilation, and air-conditioning) Water supply system Engineering maintenance Plant services

Diversionary Tactics:

Diversionary Tactics An attempt to waste auditors’ time so that they become rushed to complete the audit and thus less observant and perceptive, or even to indulge in diversionary tactics. Techniques that have been employed include: Delaying the start by prolonging the opening discussion, and requesting an early finish Prolonged tea and coffee breaks

Diversionary Tactics:

Diversionary Tactics Techniques that have been employed include: Variably timed staff breaks, making it time consuming to “the one who knows the answer” Conducting the auditor the long way around the site Confusing the auditor by surrounding him or her with many escorts or experts Giving lengthy and elaborate explanations that over exaggerate the complexity of the operation

Diversionary Tactics:

Diversionary Tactics Techniques that have been employed include: Deliberate planting of minor faults, on the theory that auditors feel that they must justify their existence by finding some faults, and that having done so, they will relax Strategically timed fire alarms or drills Taking auditors out for a lavish lunch (“It won’t take long. Just as quick as the canteen”)

The Audit Report:

The Audit Report This is something that few people like doing, but it must be done, and it is better that it is done as quickly as possible, while the experience of the audit is fresh in mind. The report is the auditors’ formal record of what was seen, done, heard, and agreed upon the report should be written, and a copy (whole or in part) sent to the auditee without delay

The Audit Report:

The Audit Report It should include all significant, nontrivial findings. It should be well-structured, and be compatible with the oral summary given at the concluding summary session

The Audit Report:

The Audit Report A suggested structure for an audit report is: 1. Site or area audited 2. Date and time of audit 3. Auditor(s) 4. Objectives and purpose of audit 5. Personnel encountered (names and positions) 6. Changes since any previous audit (organization, premises, equipment, procedures, products, etc.) 7. Observations — in logical order 8. Corrective measures requested 9. Oral responses of auditee 10. Final conclusions

Follow-Up:

Follow-Up The final phase of the audit is the follow-up. there is no point in quality auditing unless any necessary corrective action is taken and confirmed These should be confirmed by written requests , and hopefully, written assurances from the auditee that the requested corrective actions have been taken For full and final confirmation, a further on-site meeting may be held, combined with a partial or total re-audit.

Preparation Phase Of Audit:

Preparation Phase Of Audit Management Commissions Audit in writing (1-0.25 day) Audit team leader assigned (0.25 day) Audit team leader defines functional areas to be audited (1 day) Audit team member chosen (3days) Audit team assembled and briefed (1day) Audit team leader creates audit tools and template (3days) Train Audit team members (3 days) Functional area managers contacted to participate in familiarization and overview sessions (1day)

Preparation Phase Of Audit:

Preparation Phase Of Audit Audit team leader and functional area managers give familiarization and over view presentations (4days) Disclosure sessions scheduled for functional areas (1day) Hold disclosure sessions (2days) Proceed to audit and data capture phase

Preparation Phase Of Audit:

Preparation Phase Of Audit Management Commissions Audit in writing (1-0.25 day): FDA is very clear in its expectations of management commitment with respect to CGMPs . So formally commissions in audit in writing is important at some senior level. This Management Commissions Audit in writing (1-0.25 day) should include following sections. Purpose Start date End date Expected deliverables

Preparation Phase Of Audit:

Preparation Phase Of Audit Designation of Audit team leader Definition of team leader responsibility, level of authority. Commissioning document should be signed and formally issued to the audit team leader once that individual is selected. Copies of document should be circulated to all impacted personnel within organization.

Preparation Phase Of Audit:

Preparation Phase Of Audit 2. Audit team leader assigned (0.25 day): Selection of team leader is critical. An individual with good project management and organizational skills is required. The audit team leader did not need any in depth understanding of organization and its operations but should have a good command of laboratory CGMPs and understanding of laboratory control system Previous audit experience is also a plus.

Preparation Phase Of Audit:

Preparation Phase Of Audit 3. Audit team leader defines functional areas to be audited (1 day) The audit team leader works with senior management and department manager to identify those areas that need to be audited. Eg . Finished product testing lab, raw material testing lab, product stabili ty testing lab Any lab involved in in-process testing should be included in the audit. Attention should be paid to those areas which are suspected to have CGMP deficiency.

Preparation Phase Of Audit:

Preparation Phase Of Audit 4. Audit team member chosen (3days): Laboratory control system consists of 7 different subelements, Laboratory managerial and administrative systems Laboratory documentation practice and SOP Laboratory equipment qualification and calibration Laboratory facilities Methods validation and technology transfer Laboratory computer system Laboratory investigation Each of these subelements needs to be included in team

Preparation Phase Of Audit:

Preparation Phase Of Audit Ideal composition may vary depending upon laboratory or subelements to be audited. Smaller organizations with limited resources, forming 7 different terms may not be practical . Audit team should not have fewer than 2 people .

Preparation Phase Of Audit:

Preparation Phase Of Audit 5. Audit team assembled and briefed (1day): All audit team members should be assembled and briefed to their individual responsibility and responsibility of all involved party. This is done by team leader. Following topics should be covered. Introduction to team members Review of commissioning documents Scheduling for timing dates Scheduled audit start date

Preparation Phase Of Audit:

Preparation Phase Of Audit 6. Audit team leader creates audit tools and template (3days): Some of tools and templates include: A detailed audit workflow A weakly audit routine template A monthly audit schedule template An audit participant roles and responsibilities matrix A detailed audit team member training agenda

Preparation Phase Of Audit:

Preparation Phase Of Audit EXAMPLE OF AUDIT TEAM TRAINING AGENDA Goals of audit Preparation for FDA preapproval inspection(PAI) Install a self audit program for QC lab Improved operations by root Cause Analyses and Corrective Action Implementation Review of audit process Audit process workflow diagram Subelement checklist and checklist use Audit team membership, responsibilities and deliverables Audit notebooks Weekly routine Monthly calendar

Preparation Phase Of Audit:

Preparation Phase Of Audit EXAMPLE OF AUDIT TEAM TRAINING AGENDA Laboratory Audit Form (LAF) generation process Example LAF LAF numbering system Subelement audit strategy development Audit and interview schedules Statistical sampling and sampling plans Miscellaneous

Preparation Phase Of Audit:

Preparation Phase Of Audit 7. Train Audit team members (3 days): Training is usually conducted by audit team leader but may include QA personnel, consultants , personnel from other departments and divisions who have already been through an audit At minimum, training should include: Review of goals of audit An in-depth review of audit process Review of roles and responsibilities Discussion of working calendar and audit routine Instruction on data capture and CGMP deficiency documentation Audit strategy development including team member roles and responsibilities, sampling plan, etc

Preparation Phase Of Audit:

Preparation Phase Of Audit 7. Train Audit team members (3 days): The working calendar is preliminary at this stage and will be finalized with functional area managers.

Preparation Phase Of Audit:

Preparation Phase Of Audit 8. Functional area managers contacted to participate in familiarization and overview sessions (1day): These sessions are designed to introduce functional area manager to audit process. It is in opportunity for the audit team leader to get a general understanding of where and how each functional area manager fits into organization

Preparation Phase Of Audit:

Preparation Phase Of Audit 9. Audit team leader and functional area managers give familiarization and over view presentations (4days): The presentation should cover: Review of commissioning document Overview of audit process Data capture procedure Procedure for reporting findings Overview of corrective and preventive action process With the presentation, functional area manager give a very brief description of who they are, what they do and what testing their departments are responsible for executing.

Preparation Phase Of Audit:

Preparation Phase Of Audit 10. Disclosure sessions scheduled for functional areas (1day): The audit team leader works with managers to arrange times that are convenient for both parties Disclosure sessions are used to provide more detail about each manager’s area and responsibilities.

Preparation Phase Of Audit:

Preparation Phase Of Audit 11. Hold disclosure sessions (2days): Managers make presentations at disclosure sessions . All audit team members should be in attendance . Lower level supervisors who work for manager should not attend. The existence of on going or recently completed corrective actions should be presented as well.

Review Of Audit Process: Audit Process Workflow Diagram:

Review Of Audit Process: Audit Process Workflow Diagram Managers hold disclosure sessions Scheduled Subelement audit team meets Subelement audit team reviews: disclosure documents and audit checklist Team develops audit strategy Team determines and obtains additional documentation as needed Team selects personnel to interview Team develops sampling plans Team determines audit start time and location Team leader works with lab management to arrange audit and obtain what is needed

Review Of Audit Process: Audit Process Workflow Diagram:

Review Of Audit Process: Audit Process Workflow Diagram Team executes audit strategy including sampling plans LAFs generated by team members LAFs reviewed at end of work day as a group LAFs completed and signed by senior lab manager LAFs and supporting data transferred to senior lab manager LAFs entered into database and packages field Subelement audit completed Subelement rebrief session conducted End of Subelement audit

Examples Of Audit Participant Roles & Responsibilities Matrix:

Examples Of Audit Participant Roles & Responsibilities Matrix Audit team leader Functional area manager Audit team Subelement subject matter experts Quality assurance audit team member Outside member ( consultant / external department representative)

Audit Team Leader:

Audit Team Leader Responsibilities: Provide logistical support for audit Develop schedules and make role and responsibility assignments Assist managers in understanding audit process Assist managers in preparation of disclosure sessions Supervise audit preparation and execution Collect and compile LAFs Generate database Create draft audit summary report Communicate status of audit to participants and senior managements Complete audit summary report

Audit Team Leader:

Audit Team Leader Deliverables : Audit team member roles and responsibility assignment Trained audit team members Written audit work flow routines and schedules Weekly communication Audit supplies list Signed LAFs Database with LAF entries Draft audit summary report Final audit summary report

Functional Area Manger:

Functional Area Manger Responsibilities: Prepare disclosure session presentations Present disclosure session presentations Educate personnel on lab audit purpose, process Provide access to data, personnel

Functional Area Manger:

Functional Area Manger Deliverables: Disclosure session presentation Disclosed deficiencies list Supporting data for disclosure sessions Completed or pending corrective action plans

Audit Team Subelement Subject Matter Expert:

Audit Team Subelement Subject Matter Expert Responsibilities: Supervise subelement team Assist in generation of LAFs Insure proper documentation in audit notebooks Monitor collection of supporting data Insure access to audit areas, interview personnel and supporting data Participate in daily meetings Insure adherence to schedules

Audit Team Subelement Subject Matter Expert:

Audit Team Subelement Subject Matter Expert Deliverables: Documented notebook findings Reviewed draft LAFs Supporting data for LAFs

Quality Assurance Audit Team member:

Quality Assurance Audit Team member Responsibilities: Assist with audit Generate LAFs and collect supporting data Participate in daily meetings

Quality Assurance Audit Team member:

Quality Assurance Audit Team member Deliverables: Documented findings Draft LAFs

Outside member (consultant/ external department representative):

Outside member (consultant/ external department representative) Responsibilities: Assist with audit Generate LAFs and collect supporting data Participate in daily meetings Provide expertise on specific subelements Provide perspective

Outside member (consultant/ external department representative):

Outside member (consultant/ external department representative) Deliverables: Documented findings Draft LAFs

References:

References P. P .Sharma “How to practice GMPs”, 3rd edition, Vandana Publication David M. Bliesner , “ Establishing A CGMP Laboratory Audit System, A practice Guide” , A John Wiley & Sons, INC Publication John Sharp, “Good Pharmaceutical Manufacturing Practice” , CRC Press