Integration of Self Regulatory Good Practices Towards Innovations ...

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2012/SOM2/SCSC/CON/009

Integration of Self Regulatory Good Practices Towards Innovations of Sustainable Tomorrow Submitted by: Universiti Sains Malaysia (USM)

9th Conference on Standards and Conformance in the Field of Innovations and Related Good Practices Kazan, Russia 22-23 May 2012

Integration of Self Regulatory Good Practices towards Innovations of Sustainable Tomorrow Jahangir Kamaldin, PhD GLP Inspector for STANDARDS MALAYSIA and Senior Lecturer & Lead Advisor Laboratory Quality Quality, Safety Safety, Health & Environment Advanced Medical and Dental Institute Universiti Sains Malaysia

MALAYSIA Email: [email protected]

Scope of Impact of Innovation (Nano (Nano material) to Human Womb

Research & Development

Tomb

Disposal of Product

Innovation is Outcome of COMPLEX PROCESSES

© 2012 Jahangir Kamaldin

BIASNESS & ERROR in an Innovation is Unavoidable

Į = 0.05, scientifically there is 5% probability that a conclusion believed true is false © 2012 Jahangir Kamaldin

Self--Regulation & Authority Self Authority--Regulation of Innovation (Nano material) with Implication to Human/Environment

Authority-Regulate

Self-Regulate Documented Systems?

© 2012 Jahangir Kamaldin

Good Practices for QUALITY of PRODUCT SAFETY STUDY GLP: OECD Principles on Good Laboratory Practice - Introduced: 1981 by Organization for Economic Cooperation & Development - Scope: Studies conducted to gauge chemical safety for the purpose of registration/ licensing - Purpose: Assure validity of data generated in nonnon-clinical health & environmental safety studies in laboratory and field - Enforced by: National Regulator, e.g. Food & Drug Administration and Environmental Protection Agency.

© 2010 Jahangir Kamaldin

Good Practices for MANUFACTURING of PRODUCT GMP: Good Manufacturing Practices for Finished Pharmaceuticals1 - Introduced: 1992 by World Health Organization - Scope: Pharmaceutical / Therapeutic Products - Purpose: Products are consistently produced and controlled to the quality standards appropriate to their intended use. - Enforced by: National Regulator, e.g. Food & Drug Administration ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes6 - Introduced: 2003 by International Organization for Standardization p Manufacturer of medical devices - Scope: - Purpose: Assure quality and safety of medical devices during production - Enforced by: National Medical Device Authorities

© 2010 Jahangir Kamaldin

Good Practices for PRODUCT CLINICAL STUDY GCP: The ICH Guidelines on Good Clinical Practice2 - Introduced: 1997 by y International Conference on Harmonization based on national GCP of various countries established since 1968 till 1991 - Scope: Designing, conducting, recording, and reporting trials that involve the participation of human subjects. - Purpose: Public assurance that the rights, rights safety, safety and well being of trial subjects are protected. - Enforced by: National Pharmaceuticals Authorities

© 2010 Jahangir Kamaldin

Authority--Regulated Good Practices DOES NOT GIVE FULL PROTECTION Authority – Case Study of Drugs

© 2012 Jahangir Kamaldin

Authority--Regulated Good Practices DOES NOT GIVE FULL PROTECTION Authority – Case Study y of Medical Device

© 2012 Jahangir Kamaldin

Self--Regulation without Standardized Good Practices is DISASTROUS! Self

© 2012 Jahangir Kamaldin

Self--Regulatory + Authority Self Authority--Regulatory + Harmonized Good Practices § ENHANCE PROTECTION! Right Attitude (Sincere, Competent, Committed & Transparent)

Right Good Practices (Continual Improvement) Right Priority Protect Human Health & Environment while making Profit © 2012 Jahangir Kamaldin

Enhance Protection Against Adverse Innovation e g Case of Thalidomide by Grünenthal e.g. sold as drug for cough, colds & headache in 1951 – 1962 resulted > 10 000 deformed babies in 46 countries 10,000

Symbiotic Integration of SelfSelf-Regulatory Good Practices ((The PLANT VASCULAR MODEL) MODEL)

Cortex allocates & distributes energy fuels for future production § Organizational Quality Management System (QMS) QMS helps to manage resources to realize future products & sustain organization life Phloem distributes energy fuels to sustain life of plant cells § Occupational Safety & Health Mgmt. System (OSHMS) OSHMS helps to sustain life of workers developing innovation Xylem brings in water & nutrient for plant to produce energy fuels § Environmental Management System (EMS) EMS helps to select raw materials/ reagents/ apparatus of least hazardous for innovation Vascular V l Cambium C bi accurately t l determines d t i needs d & fforms th the secondary d xylem l & phloem hl ffor ti timely l growth th off plant l t§ Laboratory Competence Management System (LCMS), helps to make accurate, reliable & timely decision © 2012 Jahangir Kamaldin

Good Practices for SelfSelf-Regulatory of ORGANIZATIONAL MANAGEMENT ISO 9001: Quality Management Systems – Requirements5 - Introduced: 1994 by International Organization for Standardization - Scope: Any organizations wish to establish quality management systems (QMS) - Purpose: QMS to demonstrate ability to meet customer requirements and enhance satisfaction. -E Enforced f db by: S Self lf regulate. l t

© 2010 Jahangir Kamaldin

Good Practices for SelfSelf-Regulatory of WORKPLACE SAFETY & HEALTH OHSAS 18001: Occupational Health and Safety Assessment Series for Management System 8 - Introduced: 1999 by British Standards Institution based on BS8800 - Scope: General workplace - Purpose: Intended to address Occupational Health &Safety for employees, contractors, visitors and other personnel at workplace - Enforced by: Self regulate / National Department of Safety & Health

© 2012 Jahangir Kamaldin

Good Practices for SelfSelf-Regulatory of ENVIRONMENTAL CARE ISO 14001: Environmental Management Systems – Requirements with Guidance for Use7 - Introduced: 1996 by International Organization for Standardization based on BS7750 by British standards Institute in 1992 -Scope: Any organization wish to establish, implement, maintain and improve an environmental management system - Purpose: Assure and demonstrate conformity with environmental policy and standards - Enforced by: Self regulate / National Environmental Authorities.

© 2012 Jahangir Kamaldin

Good Practices for SelfSelf-Regulatory of LABORATORY COMPETENCE CITAC/EURACHEM Guide CG2: Quality Assurance for Research & Development and NonNon-routine Analysis9 - Introduced: - Scope: p - Purpose:

- Enforced by:

1998 by Cooperation on International Traceability in Analytical Chemistry and EURACHEM (an European Organization for Analytical Chemistry) Any organization wish to implement quality assurance in laboratories Provide Provide laboratories with guidance g on best practice p for the analytical operations they carry out. The guidance covers both qualitative and quantitative analysis carried out on a routine or nonnon-routine basis Self regulate.

© 2012 Jahangir Kamaldin

Good Practices for SelfSelf-Regulatory of LABORATORY COMPETENCE ISO/IEC 17025: General requirements for the competence of testing & calibration laboratories (formerly ISO/IEC Guide 25)4 - Introduced: 1982 by International Organization for Standardization & International Electrochemical Commission - Scope: Laboratory offering tests or calibrations services, exclude medical testing. - Purpose: Assurance of Accuracy, Reliability and Timeliness of Results - Enforced by: Self regulate / Various National Authorities ISO 15189: Medical laboratories - Particular requirements for quality & competence3 - Introduced: 2003 by y International Organization g for Standardization - Scope: Medical and Clinical Diagnostic laboratories. - Purpose: Assurance of Accuracy, Reliability and Timeliness of Results - Enforced by: Self regulate / National Health Service Authorities

© 2012 Jahangir Kamaldin

Model of Symbiotic Relationship between Good Practices of Quality Systems in Development of Chemical Products with Implication p to Human/Environment Stage 1 Discovery

Plant Extracts

Stage 2 Non-Clinical/ Lab

+ve

Assay for Bio-activity Bio-

Isolated Actives

Stage 3 Clinical/ Field

+ve

Actives Chemistry Preparation of Dose Assay for Bio--efficacy Bio Assay ffor A Human Safety (Animal Model)

EURACHEM-CITAC OECD - GLP GMP & ISO13485 GCP OHSAS18001/ ISO9001/ ISO14001/ ISO17025 ISO15189

Actives in Formulation

Stage 4 Post-Approval

+ve

Commercial Product

Preparation of Product

Preparation of Product

Chemical Profile

Quality Assurance & Control of Actives

Physical Profile Human Target Product Safety

For Product of Non Human Target

Product Effectiveness

Assay for Environmental Safety (Animal Model) (N t (Natural l Degrade) D d )

Non Human Target Product Effectiveness

Quality Assurance & Control of Physical Packaging, Label & Insert

Clinical Monitoring for Safety & Effectiveness

© 2012 Jahangir Kamaldin

Impact of Combined Good Practices of Quality Systems towards Nano material Use of SUSTAINABLE TOMORROW Management System

Outcome

Impacts Towards Sustainable Tomorrow

ISO 9001

Self regulate to fulfill stakeholders Self-regulate requirements of environmental safety & human health in developing products

Reduces introduction of innovation that damages health & environment

ISO 14001

Self regulate in reduce Self-regulate reduce, recycle & replace use of raw material that harm environment

Prudent resources use to minimize environment impact

OHSAS 18001

Self-regulate to replace or reduce use of hazardous material in work processes

Reduce use & exposure to hazardous materials

ISO/IEC 17025 ISO 15189

Self-regulate to ensure high accuracy & reliable measurements for effective decision

Reduces poor decision due inaccurate results

OECD - GLP

Industry/ Authority makes decision to register chemical based on reliable reports.

Reduces risks of harmful chemical licensed for sale

GMP ISO 13485

Product is manufactured p per intended q quality y of product specifications

Reduces risks of p poisoning, g pollution or ineffectiveness

Industry/ Authority restricts use of chemical g adverse effects to human with high

Reduces risks of detrimental impact p to health

GCP

© 2012 Jahangir Kamaldin

Symbiotic Roles of Stakeholders for EFFECTIVE SELFSELF-REGULATION

© 2012 Jahangir Kamaldin

Scenario of Self--Regulatory Good Practices Certification & Accreditation Self Under STANDARDS MALAYSIA Schemes Quality Management System (ISO 9001: 2008), Environmental Management System (ISO 14001: 2004) Occupational Safety & Health Mgmt .System (OHSAS (OHSAS 18001 & MS 1722) Laboratory Competence Mgmt. System ((EURACHEM EURACHEM// ISO 17025/ ISO 15189) QMS ISO 9000

EMS ISO 14001

OSHMS OHSAS 18001 & MS 1722

LCMS ISO /IEC 17025 & ISO 15189

5657

933

669

465

Certified/ Accredited Private & Government Institution in Malaysia Certified/ (Up to Dec 2010, STANDARDS MALAYSIA 2011 Annual Report) © 2012 Jahangir Kamaldin

Bibliography 1. Barbara Immel (2000). 1 (2000) A Brief History of the GMPs . BioPharm Magazine Magazine, August 2000 2000, California, USA. Accessible from www. immelresources.com 2. Cristina E. Torres (2008). History and Principles of Good Clinical Practice. University of the Philippines - National Institutes of Health. Manila, Philippines. Accessible from www.jirb.org.tw 3. ISO (2003). ISO 15189: Medical Laboratories - Particular Requirements for Quality and Competence International Organization for Standardization Competence. Standardization, Geneva Geneva, Switzerland Switzerland. 4. ISO (2005). ISO/IEC 17025: General Requirements for the Competence of Testing and Calibration Laboratories. International Organization for Standardization, Geneva, Switzerland. 5. ISO (2008). ISO 9001: Quality Management Systems - Requirements. International Organization for Standardization, Geneva, Switzerland. 6. ISO (2003). ISO 13485: Medical Devices - Quality management systems - Requirements for regulatory purposes. International Organization for Standardization, Geneva, Switzerland. 7. Jennifer Hankerson (2006). Environmental Management Systems: ISO 14001. Strategic Standardization Inc, USA. Accessible from www.strategicstandards.com 8. Ron Henderson (1999). Understanding OHSAS 18001:1999 and ANSI Z-10. Z 10. ABS Quality Evaluations Inc. Texas, USA. Accessible from www.abs-qe.com © 2012 Jahangir Kamaldin

HOPE YOU ARE SATISFIED WITH THE PRESENTATION

Further communication, j h [email protected] i @ di d Special acknowledgement to owners of images used in this presentation Thank you ©2009 JAHANGIR K