How will new EU countries ensure that their QP standards are acceptable?

Transcription

1 How will new EU countries ensure that their QP standards are acceptable? Faculty of Pharmacy, University of Belgrade , 2010 dr. Mila Božić

2 In the new EU countries (former CADREAC) In many aspects we still do not have all answers to meet the QP directive Most drug laws require certain specialization and specify needed experience for a RP (Responsible Person) General problem of underdeveloped legislation in transitional countries And we are all in transition to the global economy

3 Poland: QPs are M.Sc. of pharmacy, chemistry, biology 2 years experience in pharma QC/QA Notify the DA (Drug Agency) with personal CV No official registration required but: Intended change to QP position has to be notified to DA one month in advance

4 Czech Republic: QPs are mostly chemists (B.Sc.) 2 years experience in pharma QC/QA MoH organized basic training (12 modules of 2-3 days) in GMP and pharmaceutical legislation to qualify them for practice of QP s role acc. 75/319 EEC

5 Hungary: Well established, regular program for Q/GMP training of QPs (1 week/year) 3-year specialized degree at Pharmac. Faculty, for ML holder Personal registration system in place (CV, GMP training at OGYI) MRA was in place with EU before accession

6 There are huge differences among manufacturers The manufacturers with advanced QMS (which include drug development process- DDP) already release ID (Investigational Drugs) by QP/RP (acc. 75/319 EEC) The release of clinical samples is undergoing the same procedure as the market-release drugs.

7 Governments via DA are the ultimate arbiters for regulating the conditions for ID The weaknesses of QMS (Quality Management System regulations) in the pharmaceutical field makes the QP s role in the drug development process even more critical equally so in new and old EU countries. It s time to move from inspection towards quality by planning and design

8 Qualifications criteria for QP Country Qualification Responsibility Title Austria Pharmacy Chemistry/Biology Manuf. QC/QA Manager Belgium Pharmacy Manuf., MA, Medical Information Industrial Pharmacist Denmark Pharmacy Manuf. QC Manager Finland Pharmacy Manuf. Responsible director France Pharmacy Manuf., MA, Medical Information Pharmacien responsible Germany Pharm., Chem., Biol., Physic, Vet. Manuf. Head of Manuf. & Quality Control Sweden Pharmacist Manuf., Clinical trials QC Manager UK Pharm., Chem., Biol., Physic, Vet Manuf., Clinical trials QP

9 Pharmaceutical training Country Qualification UK, Greece, Ireland Germany Denmark, Finland, Austria, Belgium, Spain, Italy, Portugal, Sweden France Holland 4 years + 1 year practical experience 4 years + 1 year practical experience 5 years 6 years + Doctorate 6 years

10 How to meet requirements in EU? Reach consensus for transformation and quality leadership Improve quality of management QPs proactively advise on improvement needs for infrastructure compliance Improve understanding of the QMS and interdependence with business management

11 Quality Development Phases efficiency - efficacy - excellence Maturity TQL - Business Excellence Performance management - BSC TQM - customer focus Organisational direction QM - systemic approach Continuous improvement EU GMP Foundation - process capability ISO 9001 management reliability product quality Processes goals quality

12 The complexity of pharma R&D requires That quality of organizations and regulation evolve towards standardization (ISO) Otherwise we will miss the opportunity for proactive quality planning, implementation and control Who is responsible?

13 Building QMS compliance into existing GMP mentality is a new challenge for most EU companies, who need: Design control and development process orientation Corrective and preventive actions Management responsibilities Quality manual Change control, risk management Defined phases of development/quality plan Design review, verification

14 Pharma industry is facing disruptive innovation Social System s Infrasructure Standards Markets Technology Incremental Innovation Disruptive Innovation Chaos, Fear and Ignorance Legal System s Policy (L. Martinich, Competitivefocus, 2002)

15 Who are the QPs awaiting that innovation? We are: - Qualified persons, responsible persons/pharmacists for batch release - Quality professionals (auditors, engineers, managers) - Regulatory professionals - RPs, (compliance officers, investigators, reviewers, inspectors, ) All of them and many others

16 The background of responsibility QA according to GMP: - QA is a wide ranging concept which covers all matters which influence the quality of a product. It is the sum total of the organised elements made with the object of ensuring that medicinal products are of the quality required, is still addressed in terms of finished products testing QA according to ISO 9000:2000 (is substituted with QMS): - Part of quality management focused on providing confidence that quality requirements will be fulfilled.

17 A QP needs: Reliable QMS in place Transparent process management Defined competencies, awareness, training Clear reporting system of all deviations, changes and corrective actions Appropriate experience and scientific background Independent decision-making

18 It is up to regulation / legislation to support QP s needs Define the rules for the QMS - adapt ICH Q, 8,9,10 in place Impose certification system for QPs / RPs (Investigators and Inspectors) Accreditation system for control bodies, reg. agency and control laboratories

19 In EU we need to ensure Competitive Quality first at the regulatory and then at the corporate level Strategic Tactical Q Q policy QM system Operational Personal, Team Q

20 Quality Leadership development What counts is who you are? 1. Personal style/skills Relative importance of the skill 2. Managerial skills 3. Technical skills PROFESSIONAL MANAGERIAL EXECUTIVE (Leadershipagenda, 2002)

21 Performance The levels of QP s competence development World Class Excellence Leader (Black Belt) Expert QP / RP Proficient Quality manager Novice Advanced Beginner Quality engineer Quality auditor Time

22 Key steps of QP role development QPs become quality leaders and improve BE QPs help to switch from product/ control view to systemic/qm view QPs proactively build new quality strategy QPs become authorised quality professionals

23 Unified Approach of Certification in EU

24 Summary Global drug market and intensive outsourcing practice: Redefine the needs for harmonized QPs / RPs education and certification Harmonized program has to be founded on - Right personality (self-confident, independent, ethical, diplomatic and brave) - Certified scientific background (harmonized scheme for QP / RP professionals) - Profound experience and practice (5-10 years minimum) in Pharma processes

25 Thank you for your kind attention It s up to Us (QPs) to Light Our Own Small Fires in the Darkness. Charles Handy (The empty raincoat, Making sense of the future)