quality management systems in different industries - from iso 9001 to cgxp

Quality Management Systems (QMS)

Luc Marivoet & Luc Huybreghts Antwerp, March 30 , 2017

0 Presented by

Luc Marivoet, Senior Consultant QM / Engineering Services Luc Huybreghts, Senior Consultant QA & Compliance

LUC²Lecturers Using Craftsmanship in QMS

0 Goal

The goal of today’s session:Guide you through the world of Quality Management Systems (QMS)

• What is a QMS• Importance & benefits of a QMS• Different types of Quality Management Systems:

• Process-oriented : ISO 9001 – Luc Marivoet• Product-oriented : cGxP – Luc Huybreghts

• ISO 9001 and cGxP: a comparison• Conclusion

1 A brief history of Quality

How it startedHandcrafting

Industrial RevolutionMass production

Deming, Juran and JapanImproving organizational process

World War IISampling for inspection

The American ResponseTotal Quality Management

Late 20th CenturyQuality Management System

What• Definition: A system by which an organization aims to reduce and

eventually eliminate nonconformance to specifications, standards, and customer expectations in the most cost effective and efficient manner.

Benefits• Meeting customer’s requirements• Meeting organization’s requirements

2 Quality Management Systems

Different approaches• Process-oriented: ISO 9001• Product-oriented: cGMP

2 Quality Management Systems

What• Most popular standard.• Agreement or best practice.• Reflects professionalism.

Benefits• Consistent quality.• Meet the customer’s requirements.• Comply with the law and legislation.• Meet the organisation’s own requirements.• Streamline your business processes.• Increase customer satisfaction.

3 Quality Management System ISO 9001

Historical timeline

ISO9001:1987

Procedures

ISO9001:1994

Say what you do

& do what you say

ISO9001:2000

Process Approach

& PDCA

ISO9001:2008

Process Approach

& PDCA

ISO9001:2015

Context

Risk / Opportunity

Normative reference• QMS standards for which ISO 9001 is a normative reference:

ISO 9000 series

ISO 9000Quality

Management Systems

–Fundamentals and

vocabulary

ISO 9001Quality

Management Systems

–Requirements

ISO/TS 9002Quality

Management Systems

–Guidelines for the

application ofISO 9001:2015

Plug-in model

4 Quality Management Principles

1. Customer Focus

2. Leadership

3.Engagement

of people

4. Process Approach

5. Improvement

6. Evidence-based

Decision Making

7. Relationship

Management

5 Key Requirements of ISO 9001

4. Context of the organization• Understanding the organization and its context. • Understanding the needs and expectations of interested parties.• Determining the scope of the quality management system.• Quality management system and its processes.

4. Context of the organization• Understanding the organization and its context.

STRATEGY

EXTERNAL ISSUES INTERNAL ISSUES

4. Context of the organization• Understanding the organization and its context.

STRENGTH WEAKNESS

OPPORTUNITY THREAT

4. Context of the organization• Understanding the needs and expectations of interested parties.

4. Context of the organization• Determining the scope of the quality management system.

4. Context of the organization• Quality management system and its processes.

5. Leadership• Leadership and commitment. • Policy.• Organizational roles, responsibilities and authorities.

5. Leadership• Leadership and commitment.

• Policy.

• Organizational roles, responsibilities and authorities.

6. Planning• Actions to address risks and opportunities. • Quality objectives and planning to achieve them.• Planning of changes.

6. Planning• Actions to address risks and opportunities.

6. Planning• Quality objectives and planning to achieve them.

6. Planning• Planning of changes.

7. Support• Resources. • Competence.• Awareness.• Communication.• Documented information.

7. Support• Resources.

7. Support• Competence.

7. Support• Awareness.

7. Support• Communication.

7. Support• Documented information.

8. Operation• Operational planning and control. • Requirements for products and services.• Design and development of products and services.• Control of externally provided processes, products and services.• Production and service provision / Release of products and services.• Control of nonconforming outputs.

8. Operation• Operational planning and control.

8. Operation• Requirements for products and services.

8. Operation• Design and development of products and services.

8. Operation• Control of externally provided processes, products and services.

8. Operation• Production and service provision.

• Release of products and services.

• Control of nonconforming outputs.

9. Performance evaluation• Monitoring, measurement, analysis and evaluation. • Internal audit.• Management review.

9. Performance evaluation• Monitoring, measurement, analysis and evaluation.

CONFORM ISO 10004

9. Performance evaluation• Internal audit.

CONFORM ISO 19011

9. Performance evaluation• Management review.

10. Improvement• Nonconformity and corrective action. • Continual improvement.

10. Improvement• Nonconformity and corrective action.

NONCONFORMITY CORRECTION

CORRECTIVE ACTION ACTION TO ADDRESS THE RISK

10. Improvement• Continual improvement.

?QUESTIONS

6 Questions

What• Definition: A system by which an organization aims to reduce and

eventually eliminate nonconformance to specifications, standards, and customer expectations in the most cost effective and efficient manner.

Benefits• Meeting customer’s requirements• Meeting organization’s requirements

R Quality Management Systems

Different approaches• Process-oriented: ISO 9001• Product-oriented: cGMP

R Quality Management Systems

Good Manufaturing Practices• What – why • Historical overview• Structure

• Eudralex• FDA

• Evolution – latest trends• Dangers & pittfalls• Business enabler

Comparison & relation with ISO

Conclusion

Do you trust the pill you took today ?

The Matrix

Quality should be built into the productand testing alone cannot be relied on

to ensure product quality.

Quality & Compliance

ManagerThe function holder will maintain a Pharmaceutical Quality System as defined in Article 47 of Directive 2001/83/EC and laid down in Eudralex Volume 4 GMP guidelines;

in both GMP and GDP requirements and in ISO standards

Responsibilities:• Review and improve the Quality Management System • Coordinate the quality system activities• Ensure that necessary KPI’s are in place• Coordinate the activities of inspection readiness and ISO certification• Definition of Quality Objectives and development of a Quality Mindset• Provide input for Quality Improvement Meetings and Quality Review Meetings

What• current Good Manufacturing Practices • Pharmaceutical industry – life-sciences• It is the LAW – regulatory authorities

Belgium: FAGGBrazil: ANVISA EU: EMA UK: MHRAUSA: FDA

IndiaIsrael

Biologics Control Act

Federal Food,Drug and Cosmetic Act

Guidance Documents

ChineseMilk Scandal

Tylenol

Thalidomide

The Pure Food and Drug Act

Public Health Services Act

19021906

19381944

19621979

19821998

20082013

UpdateEudralexChapter 1

cGMP - timeline

What• minimum requirements – what to do, never how• Current: continuous improvement – use up-to-date techniques• Flexible • cGxP

Finding Proof of Principle

Animal Studies

Clin. Phase

Market

GLP GMPGCP

GMPGDP

Why• patient protection• a response of the authorities• prevent future tragedies• processes: reliable and reproducible• quality is built into the design and manufacturing – at each step• identity, strenght, quality and purity of drug products

cGxP – general

Combination of regulations and guidelines

Regulatory Authorities: Argentina Egypt RomaniaAustralia FDA Saudi Arabia Austria ICH SingaporeANVISA India S. AfricaCanada Ireland S. KoreaChina Italy UAECzech Rep. Malaysia Venezuela EU MexicoMHRA

Guidance standardsICH International Conference of HarmonisationPDA Parenteral Drug AssociationPIC/S Pharmaceutical Inspection Convention

Mandatory standardsWHO – World Health Organization

Latest trends in cGMP:

• ICH – International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use• EU – Japan – USA: harmonization• April 1990: Brussels• Q9 – Risk Assessment• Q10 – Pharmaceutical Quality Systems• Q11 – Development and manufacturing of drug substances (draft)

Latest trends in cGMP:

• PDA – technical reports – industry practices• PIC/S : partner of WHO, Unicef, EMA – 46 countries

• Facilitate to maintain mutual confidence • Exchange cGMP information and experience• www.picscheme.org

Structure GMP (Eudralex volume 4)• Part 1: GMP Chapters + Annexes (19 Guidelines)

GMP Chapters (Part1) Annexes

1. Pharmaceutical Quality System 1. Manufacture of Sterile Products

2. Personnel 2. Manufacture of Biological active substances and Products for human use

3. Premise and Equipment 3. Manufacture of Veterinary Products

4. Documentation 6. Manufacture of Medicinal Gases

5. Production 9. Manufacture of Liquids, Creams and Ointments

6. Quality Control 11. Computerised Systems

7. Outsourced Activities 15. Qualification and Validation

8. Complaints and recall 17. Parametric Release

9. Self Inspection 19. Reference and Retention Samples

Structure GMP (Eudralex volume 4)

• Part 1: GMP Chapters + Annexes: 1-19 (guidelines)• Part 2: Basic Requirements for Active Substances used as starting

materials• Part 3 – GMP related documents

o Site Master Fileo Q9 Quality Risk Managemento Q10 Guidance on Pharmaceutical Quality Systemo MRA Batch Certificate

Structure GMP (FDA Code of Federal Regulations)US FDA Title 21 CFR Parts

• Part 11 – electronic records and signatures• Part 210 – Current Good Manufacturing Practices in Manufacturing,

Processing, Packaging or Holing of Drugs; General• Part 211 – Current Good Manufacturing Practice for Finished

Pharmaceuticals• Part 600 – Biological Products: general• Part 601 – Licensing Biologics• Part 610 – General Biological Products Standards

Structure GMP (FDA Code of Federal Regulations)Guidance Documents – Guidance for industryImplement modern quality systems – risk management

Inspection by regulatory bodies:• Regular inspections

• Pre-approval inspections (PAI)• System based inspections: full ≥ 4 systems partial ≥ 2 systems

• Observations: • 483 – warning letter• published

GxP-basic QMS model

Resource

• Raw materials• Packaging materials• Personnel: training & hygiene• Premises & equipment

• Maintenance• Calibration• Environmental monitoring

• Validation• Processing• Quality Control• Warehousing• Distribution

Manufacture

• Quality Management• Key Personnel• Documentation• Complaints & recall• Self inspection

System Control

Quality Data

• Batch records• Samples• Release

• Products• Patients

Management responsibilities

PQS elements: process performance – product quality monitoring system – CAPA system – Change Control system management review system

Enablers: knowledge management – quality risk management

Pharmaceuticaldevelopment

TechnologyTransfer

Commercialmanufacturing

Productdiscontinuation

cGxPInvestigational

products

cGMP - PQS

Pharmaceutical Quality System

1. Management belief – commitment

Sometimes we can’t follow procedures. We have a business to run.The validation results were marginal. We can improve the process later.We often see this manufacturing problem. We routinely rework and 100% inspect.That test result is barely out of spec. We know it is good product to release.

• cGMP compliance is not a frustrating hurdle to get product to the market• Company culture• Daily experience with pharmaceutical quality assurance is lacking• Walk the talk

cGMP - Pittfalls

2. Quality function is detached from operations

I know this is a compliant procedure. I used it at my last companyYou are not following cGMP’s. You are supposed to use blue ink.I’m not going to deliver the bad news. That would kill my career.Don’t talk to me about cost. Quality doesn’t care about cost.

• Quality unit – regulated by Code of Federal Regulations• Develop procedures in isolation – no integration• A partner – do not lose independence• QA professionals must have a working and process knowledge• QA professionals must have core skills, not just cGMP compliance

cGMP - Pittfalls

3. Inadequate management review

Are we ready for an inspection? Quality had better be sure we are.Backlog of overdue investigations again ? Dedicate a team to close them ASAPA repeated inspection observation? I thought we resolved that problem

• Management personally responsible • State of cGMP compliance of their operation – QMS metrics• Quality Management Review• Logical PQS – not a random collection of poorly written procedures• 4 basic management questions• System owners are responsible for the metrics and present them

cGMP - Pittfalls

4. Large scale cGMP performance improvement

The CAPA implementation efforts are going nowhere. Manufacturing department says their priority is the production scheduleWe agreed that on-the-job-training is needed to reduce the human error rate, but we were just told to cut our training budget by 20%.We know that unavailability of clean vessels cause a bottleneck in the manufacturing schedule, but our capital request are continuously denied.

• Warning letters are phrased as failures of the quality unit• Problems are often site-wide – multiple functions have to collaborate• Align support for cGMP initiatives

cGMP - Pittfalls

cGMP an obstacle for business ?

• Business enabler:• Individual dose – every day – not an average quality• Quality only happens intentionally• Quality can’t be tested into a product• Standard operating procedures• Documentation proves the work• Records – performance metrics• Review and trending anticipating organization, not a reactive one

Similarities• Written procedures and records• Controlled documents• Personnel properly trained• Work environment maintained• Non-conformances & complaints addressed • Corrective and preventive actions• Equipment maintained• Quarantining of product before release• Product release, analysis of products• Conformance to specifications

cGMP – ISO 9001: a comparison

• Specific for pharma (manufacturing of medicines)

• A legal requirement• Product quality focused:

• safe, pure & effective• Detailed requirements:

• what – not how• Narrow scope: production & QC• Quality unit

ISO 9001

• Generic – for all types of organsiations

• Voluntary – industry practice• Business focussed

• customer satisfaction• Not as detailed as GMP

requirements• Wide scope: entire organisation• Management representative

Differences

cGMP – ISO 9001: comparison

Conclusion

• It is not either ISO or GMP – it can be both• GMP operations benefit from adding ISO 9001 required measurement,

review and customer satisfactions programs• IOS companies benefit from GMP’s system control requirements and

from the standard to demonstrate “safety, strength, quality and purity” of the product

• Demonstrate Quality Oversight

• Harmonization – ICH

Quality Management System(s)

Questions?

?QUESTIONS

Further information

Luc MarivoetSenior Consultant QM / Engineering Services

luc.marivoet@pauwelsconsulting.com09 – 324 70 80

Luc HuybreghtsSenior Consultant QA & Compliance

luc.huybreghts@pauwelsconsulting.com09 – 324 70 80

Quality Management Systems (QMS)

Luc Marivoet & Luc Huybreghts Antwerp, March 30 , 2017

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