PDA: A Global. Association. Contract Giver - Management of Change. Eamon Kelly. Director, External Quality (EMEA)

Transcription

1 Contract Giver - Management of Change PDA: A Global Eamon Kelly Director, External Quality (EMEA) Association Janssen Pharmaceutical Companies of Johnson & Johnson. Nov 22 nd 2018

2 (c.535 c.475 BC) Heraclitus of Ephesus The Only Constant Is Change (2013.Professional and Science) more organizations will realize that their ability to "out-change" the competition is what will set them apart, and the discipline of change management will become a strategic differentiator. 2

3 Agenda Company Background Janssen Janssen Organization Quality Oversight of Outsourcing Janssen Principles of Quality Oversight of External Manufacturers Janssen Change Management Process High level Overview Janssen Change Management Process - Lessons Learned Key Takeaways

4 J&J Supply Chain J&J Medical Devices Companies Surgery Pharmaceutical Consumer Medical Solutions 4

5 J&J Supply Chain 1 billion customers served every day! 58,000 associates and contractors 125 internal manufacturing sites 650 external manufacturers 5,850 suppliers All numbers are for indicative purposes only. 5

6 J&J Ireland

7 OUR CREDO Performance Management & Decision making driven by Our CREDO

8 Janssen Organization Quality Oversight of Outsourcing

9 External Supply Integration Quality (ESIQ) At Janssen, External Supply Integration Quality is the group responsible for the quality aspects of EXTERNAL GXP activities 1. External Contract Labs & Clinical External Manufacturers (EMs) 2. External suppliers for Internal Janssen sites & EMs 3. External Manufacturing (Fill finish) * Does not include suppliers/ems/ecls under qualification Biologics Cell therapy Small Molecule (tablets, liquids, nasal spray, etc.) Diagnostics Vaccines DNAs Peptides Oligonucleotides

10 External Supply Integration Quality (ESIQ) Supplier Quality Quality Oversight of global suppliers providing materials to Internal Sites ~1600 direct sources Direct product capture Pre formulated bulk Bio process Components Media / resins Raw Materials Val. Cleaning agent Cell Banks JSC Large Molecule API Sites JDx (Invitro Diagnostics) JSC Small Molecule API Sites JSC Fill Finish Sites Starting Materials Intermediates API chemicals Critical RMs Primary Packaging Mat. + select indirect sources Instrumentations Packaging Materials Reagents IVD Assays APIs Excipients Packaging Materials Devices Combo Product components

11 ESIQ Fill Finish Manages Drug Product External Manufacturers (EMs) with 3 regional groups Commercial and Clinicals Parenteral Patches Inhalers Tablets Solids Semi Solids Lyophilized 18 EMs North America + 17 EMs South America Doing business in 10 countries 48 EMs Europe EMs +10 re-packers Asia Pacific VELCADE in Oncology ZYTIGA and prostate cancer STELARA and plaque psoriasis RISPERDAL in mental health Janssen has a very broad range of activities outsourced 11 Quality oversight is managed by a group with clear definition of responsibility

12 Janssen Principles of Quality Oversight of External Manufacturers (and how they relate to change management)

13 Quality Oversight Outsourced Activities Key Processes: Quality Agreements Risk Management Person In Plant (PIP) Proactive Quality PDMS & ECL Fill/Finish Central Operati ons & Strateg y Supplier Quality Each oversight process is linked to many other processes including Change Management 13

14 1 4 ESIQ Controls: Quality Agreements Example for commercial fill/finish Intra Company Quality Agreements and Agreements with EMs are necessary Quality Agreements are mandatory to ensure clear understanding of respective responsibilities across a range of processes including change management

15 Quality Agreement (intra company) references to change INTRA COMPANY QUALITY AGREEMENT ESIQ will ensure that Janssen originated change requests affecting the contracted activities of the subject product(s) will be communicated to the EMs, assessed for their impact by the relevant EMs and managed by both ESI Q and the EMs. All changes will be formally documented in the ETS change control system. Changes issued by the External Manufacturer and communicated to Janssen will be captured in Janssen s ETS change control system and initially assessed by ESI Q. If there is impact on the regulatory filing and/or systems or processes defined in the quality agreement, ESI Q will generate a Janssen change control, involving the necessary representatives of other Janssen departments in line with the relevant SOPS ESIQ oversees outsourced activity on behalf of internal Janssen sites An intracompany quality agreement clarifies/documents respective responsibilities 15 across a range of processes including change management

16 Quality Agreement (with supplier) references to change INTER COMPANY QUALITY AGREEMENT TEMPLATE Supplier shall have a formal change control process in place to ensure review of changes for impact on product quality and regulatory requirements. Supplier shall notify Janssen of any changes that may impact product quality or regulatory requirements 6 months before implementation. The change shall be notified in writing per established change notification procedure. Supplier shall not implement any changes impacting Product(s) quality or regulatory requirements without Janssen prior written consent. Product(s) must be controlled and NOT shipped until all approvals have been received and there is a Janssen notification to proceed. Minor changes (without any impact on regulatory requirements and product quality) shall be routed and approved by each individual company and require no notification of the other party. Janssen uses a standard template for quality agreements with all suppliers 16 It defines our minimum expectations regarding change management

17 Risk Management EM Criticality Level Risk Register Performance Proactive Risk Elements EM Quality Score (SQS) Backbone of EM Risk Management Mitigation 4 up Quality Systems Management Review Business Environment Quality Systems Audit Schedule * Does not include suppliers/ems/ecls under qualification

18 Risk management references to change EM can only get on Janssen Approved Supplier List (ASL) after Janssen manages qualification/impact assessment activities via Janssen change control The risk rating of an EM is driven by the activity taking place at the EM and by the performance of the EM across a range of criteria including change management If an EM is defined as high risk then risk control activities are required that may include risk control relating to change management Every supplier has a risk rating performance relating to change management is a driver for risk rating

19 Person in Plant (PIP) ESIQ assigned Assigned to mitigate risks Defined duration or permanent Normally spends > 50% time at EM > 50% of time at EM/Supplier Build relationship/trust Facilitate information flow Support QA processes Change Control Deviations Batch Release Regulatory Inspection Deployed for a pre defined duration Typical reasons for deployment Upgrade Plant & Plant Systems upgrade NPI through successful PAI Support routine manufacturing and batch release activities 2 way interactions

20 Person in plant references to change Effective change management is dependent on effective communication A person in plant facilitates information flow including information relating to control of change In many cases as part of risk mitigation Janssen will deploy a Person in Plant (PIP) A key responsibility of the PIP is to enhance communication, a key component of change management

21 Proactive Quality SUPPLIER QUALITY RISK CATEGORIZATION 1 2 X FUNCTIONAL SUPPLIER INDICATORS 3 PROACTIVE ENGAGEMENTS SELECTION 6 RISK PREVENTION SCORECARD 5 BUSINESS CASE & PROACTIVE APPROACH 4 ACCOUNT PLAN (Selected Proactive Suppliers)

22 Proactive Quality Change Management Cross Functional Team manages EM Oversight (Quality, Operations, EHS, Technical Operations, Finance, Planning) Annually agree an Account plan with EM Account Planning & Governance Process proactively ensures clarity on control of changes Quality Oversight is carried out as part of a Janssen Cross Functional team Proactive Account Planning is key to successful oversight This includes proactive identification of upcoming changes 22

23 Change Control Management Key considerations Janssen Change Management Process High level Overview 23

24 Pre Change Control Process Pre COC process ensures discretionary changes are aligned to business objectives

25 Change Management - Process

26 Janssen Change Management Process Lessons Learned 26

27 Lessons Learned Change Management Clear Communication initial description, regular process of communication Risk Management all changes introduce risk, ensure external manufacturer is competent to effectively assess risk Significant changes require formal project planning Introduction of changes and change management must be adequately resourced Challenge the rationale/necessity of each change Significant changes require stakeholder identification and buy in 27

28 Lessons Learned Change Management Use PQR review - To determine if all changes are being communicated from the external manufacturer - To assess full impact of all changes on product characteristics Awareness of changes upstream impacting our material whether they are minor or not (Suppliers of our suppliers) Localized external manufacture requires particular attention Strong collaborative relationship with the external manufacturer is key to effective change management 28

29 Janssen Change Management Process Key Takeaways 29

30 Key Takeaways Robust cross functional organizational structure with clear responsibilities is required for the oversight of external manufacturers Effective change management ensures supply of product to the patient that meets required standards of safety, efficacy and quality Quality Oversight Processes are inter connected Initial assessment by the external manufacturer is critical A rigorous due diligence/qualification process must be in place to ensure only competent external manufacturers are chosen Quality Agreement must be clear to support the communication process (both ways) 30

31 The Only Constant Is Change - Heraclitus of Ephesus (c.535 c.475 BC) 31