Serialization at Teva. Haarlem site

Transcription

1 Serialization at Teva Haarlem site

2 Presentation Agenda 01 Introduction Teva Haarlem 02 Serilaization Scope Haarlem 03 Construction, Commissioning & Qualification 04 Execution, Experiences & Future Challenges 05 Recommendations 06 Questions 2

3 Teva in Haarlem Click to edit quote - optional

4 Teva in Haarlem Story Click to edit Sub Title text Company start of Pharmachemie OPG (current Medique/Brocacef) buys Pharmachemie Commissioning of the factory and offices at Swensweg 5 in Haarlem Teva buys Pharmachemie Relocation of the production of Oral Solid Forms and non cytostatic injections to two Teva plants in Hungary Integration of Ratiopharm Opening building complex at Swensweg 3 in Haarlem Opening of the new Inhalation Capsule Production factory (ICP) 4

5 Production in Haarlem Parenterals: Medications for treatment of cancer (vials) Inhalation Capsule Producton (ICP) Medications for the treatment of lung diseases (capsules dry powder inhalation) Packaging: Packaging of produced medicines Supply Chain Sales, Storage, Distribution of medicines

6 Parenterals Working aseptically Air treatment system Cleanrooms Cloting regime High demands on hygiene A wide range of medicines Comples injectable products 6

7 Inhalation Capsule Production Products for the treatment of asthma and chronic obstructive pulmonary diseases (COPD) Single Dose capsules with ultra-fine powder that is inhaled by the patient with the aid of an inhaler 7

8 Sales & Marketing Teva Nederland The largest supplier of medicines in the Netherlands 1 in 6 medicines delivered by pharmacies comes from Teva Nederland Customers: wholesalers, community pharmacies, hospital pharmacies, specialists, drugstore chains Innovative medicines Generic drugs Hospital products Freely available medicines (OTC) Dietrary supplements 8

9 Serialization Scope 2 Teva existing vial Packaging lines 1 existing CMO packaging line No aggregation Markets US EU CMO (e.g. Egypt) 9

10 Construction OptelVision System Design 10

11 Construction ERP Order information Article basic information Logistics Data & Interfaces Design Article layout informaton Pack & Graphics MES Serial numbers Local IT TGO Customer Repository Label layouts & carton csv Pack & Graphics Line Master Recipe Data format Serial number cache E&M Admin Packaging Supervisors GRS Serial numbers Global IT MES Stock Warehouse Zebra Corner wraps (2x) E&M Pharmaproof Frame data timing E&M Admin Packaging Supervisors Wolke Layout file E&M GRS reports Batch & audit trail Line Master Number reports Serial number investigations QA GRS (SAP ATTP) E&M Camera (2x) P IT Haarlem Number reports Global IT Packaging supervisors 11

12 Construction Artwork Design 400 products (sizes, lay-outs) Shipper Case labels 12

13 Construction Line Design Current lines with legacy machines nt ) Camera 2 Casepacker 3 Camera 2 Labelling machine 13

14 Construction Points to consider Countries Producst Regulations 14

15 Construction Consider System Complexity, there are Many options Many components Consider Interfaces involved on Devices Lines IT Infra MES ERP Cameras Printers 15

16 Commissioning & Qualifications (C&O) Set Up Global Team in Place Facilitating on a Technical level / Shared Site (Library) Structure Process / Performance Qualifications / Multi Market and Family Approach Local Procedures System Life Cycle approach / V model SOP s (Deliverables / Qualification track) Local Team Teva staff plus externals (Engineering and Qualification 16

17 Commissioning & Qualifications (C&O) Set Up Global Team Provides Technical & Qualification Templates (URS, VP, VSR, etc.) Q approach / IT Support Local Team Line Design Local Interfaces Commissioning & Qualification Implementation 17

18 Execution Impact on organisation / preparation Artwork (Pack & Graphics) QA Systems (Change Procedure) and QA Release Packaging Operations (System Users) Maintenance (System knowledge) IT Logistics Validation Engineering & Maintenance (Administrators) 18

19 Current situation at Teva in Haarlem All 3 lines Serialization working Systems validated 19

20 Experiences Large impact due to design Stand alone system / Single Line Units preferred Limit moving elements Keep printing and image acquisition out of trembling platforms Fix unit during printing and camera reading, avoid bulging of the surface to be printed Consider Tamper Evident method and Line Integration 20

21 Experiences Knowledge gap System Complex system Different components Interfaces MES ERP IT Intra Serial number repository Regulations Vision systems 21

22 Experiences Site Focus Produce as much as possible Project Priority Versus Day to Day practice 22

23 Experiences Supplier Very busy Large growth, learning organization itself. Big differences in knowledge level and skills of technicians involved. Limited Software experience Improvement needed on Smart Design and Integration (e.g. MES interface) Limited GAMP experience Version control 23

24 Future challenges Configuration new markets Establishing an SLA Aggregation? (Russia, USA (2023)) Software updates (MES integration) 24

25 Recommendations Supplier Evaluation Select supplier with GMP experience and experience on EU regulations Create Team with supplier with fixed contacts and rapid support (take time zone difference into account) Audit quality system of supplier, special attention to be given to version control of documents and software (design) 25

26 Recommendations Design Stand alone solution / modular design preferred. Avoid moving platforms where printing and image acquisition (camera s) are concerned. Smart configuration management required. 26

27 Recommendations Organization Form a Project Team with as much members of your own organization (benefit: learning / experience track and knowledge preservation) (Local) Project Sponsor is essential (priority: provides championship to the project / resource assurance (staff and budget)) Be patient but persistent (remember you are in this together, it s a team achievement) 27

28 Questions? Do you have any questions? 28

29 Thank you. Erik Sanders Senior Project Manager Teva in Haarlem