Presentasjon Transport og logistikk Fresenius Kabi. Strenge krav til en feilfri transport og logistikk 23/10/2017. Copyright Fresenius Kabi AG

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1 Presentasjon Transport og logistikk 2017 Fresenius Kabi Strenge krav til en feilfri transport og logistikk 23/10/2017 Copyright Fresenius Kabi AG 10/18/2017 1

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3 Agenda 1 Presentasjon av Fresenius Kabi 2 GDP innen transport 3 Fresenius krav til transport 4 Valg av transportør Copyright Fresenius Kabi AG 10/18/2017 3

4 Presentasjon av Fresenius Kabi 1 Presentasjon av Fresenius Kabi 2 GDP innen transport 3 Fresenius krav til transport 4 Valg av transportør Copyright Fresenius Kabi AG 10/18/2017 4

5 Fresenius Kabi Norway, Plant Halden Fresenius Kabi Norway Plant Halden Our plant in Halden specializes in the production and distribution of IV Drugs and Standard solutions, both for Fresenius Kabi world wide and through product partnering.

6 Fresenius Kabi Norge Facts & Figures Plant location: Halden Local Market Unit: Oslo Sales in 2016: MNOK Export rate: 94% Employees: 574 Founded in: 1977 Property: m 2 Total floor area: m 2

7 Fresenius Kabi Norway, Plant Halden Manning overview Number employed FTEs, : Manufacturing 327 QA/QC Quality dept. 76 Supply Chain/Warehouse 43 Adm./reg./finance/IT/others Technical department 17 Total number of FTE s: 499 Total number of employees:

8 Fresenius Kabi Norway, Plant Halden Container Variety PP Ampoules ml & Vials ml 3 BFS machines, 1 blistering and 4 packaging lines freeflex bags ml 3 freeflex lines Filling of premade PVC bags 1 line. To be phased out. Not US PP Disinfection bottle ml 1 line. Not US PP Irrigation bottle ml 2 lines. To be phased out. Not US Cassettes with inner bags 1 line. Backup US until 2015

9 Fresenius Kabi Norway, Plant Halden Markets 94% of production for export Markets served worldwide with both own products and product partnering products High sales in markets like US, China & EU Regular inspections and audits from authorities and customers

10 GDP Innen transport 1 Presentasjon av Fresenius Kabi 2 GDP innen transport 3 Fresenius krav til transport 4 Valg av transportør Copyright Fresenius Kabi AG 10/18/

11 Global GDP guidelines Copyright Fresenius Kabi AG 10/18/

12 Development - Old / New Guidelines 1994 Old Guideline on Good Distribution Practice (4 pages) Address treat of falsified / counterfeit medicinal products entering the legal Supply Chain Update driven by increased complexity in the global distribution network. Expectation in line with general GMP principles with more detailed requirements and how to address these New Guidelines on Good Distribution Practice (32 pages) Copyright Fresenius Kabi AG 10/18/

13 Scope of GDP Transport needs Good Manufacturing Practice (GMP) Good Distribution Practice (GDP) GDP Transport Parcels within Norway Temp : GDP Transport FTL within Norway Temp : Manufacturing Warehouse GDP Transport FTL within Europe Temp : GDP Transport FCL reefer Temp : GDP Transport Air Transport Temp : Copyright Fresenius Kabi AG 10/18/

14 Good Distribution Practice (GDP) Manufacturers, Distributors, Wholesalers and Transport companies within Europe is required to follow this guideline. Good Distribution Practice (GDP) is an extension of the quality regulations covering the manufacture of products (GMP) to incorporate the storage and distribution of medical products GDP Guidelines is created to ensure that all the skill and expertise given to the manufacturing process is not destroyed by unprofessional handling of medical products during storage and transportation. Prepared in accordance with Council Directive 2001/83/EC of March 2001 Copyright Fresenius Kabi AG 10/18/

15 Requirements GDP Storage, handling and distribution should be performed in accordance with approved procedures. Products and materials should be maintained under conditions defined in the product specifications. Each FK unit or third party involved in the storage, handling or distribution have established a documented management system that addresses the requirements of the GDP standard. 1. Quality Management System 2. Personnel / Training 3. Premises and Equipment 4. Documentation 5. Operation Qualification of suppliers Qualification of customers Goods receipt Storage 6. Complaints, returns, suspected falcified medicinal products and recall 7. Outsourced activities 8. Self inspections 9. Transportation 10. Specific provisions for Brokers Copyright Fresenius Kabi AG 10/18/

16 2. Personnel / Training Responsible person needs to be appointed. The RP must ensure that the conditions of the WDA have been and are being complied with and that the GDP guidelines are being followed Records shall be available at the site that describes each person s qualification, responsibility and tasks. Proper training in relation to Good Distribution Practice and safety shall be provided and documented for all relevant personnel, including drivers. Copyright Fresenius Kabi AG 10/18/

17 5. Operation Qualification of suppliers Wholesale distributors must obtain their supplies of medicinal products only from persons/companies in possession of a wholesale distribution authorization, or a manufacturing authorization for the product(s) in question. Qualification and approval of suppliers, should be performed prior to any procurement of medicinal products. This should be controlled by a procedure, documented and periodically rechecked. When entering into a new contract with new suppliers, the wholesale distributor should carry out due diligence checks in order to assess the suitability, competence and reliability of the other party. Attention should be paid to: 1. The reputation and reliability of the supplier; 2. Potential falsification; 3. Large offers of medicinal products which are generally only available in limited quantities; 4. Out-of-range prices. Copyright Fresenius Kabi AG 10/18/

18 7. Outsourced activities Any activity covered by the GDP guide that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings which could affect the integrity of the product. There must be a written contract between the contract giver and the contract acceptor which clearly establishes the duties of each party. The contract giver is responsible for assessing the competence of the contract acceptor to successfully carry out the work required and for ensuring by means of the contract and through audits that the principles and guidelines of GDP are followed. An audit of the contract acceptor should be performed before commencement of, and whenever there has been a change to, the outsourced activities. Copyright Fresenius Kabi AG 10/18/

19 9. Transportation Transportation of pharmaceutical materials shall only happen using approved freight companies. These companies shall have been through a review process and a contract must be available. Products shall be transported in such a way that: The identification of the product is not lost. The required storage/transport temperature is maintained. The product is not contaminated by other products or materials. Adequate precautions are taken against spillage or breakage. Transit times shall be kept to a minimum. The product is not stored in an unsuitable area during transit. Copyright Fresenius Kabi AG 10/18/

20 9. Transportation Temperature logging: It should be possible to demonstrate that the medicines have not been exposed to conditions that compromise their quality and integrity. If a temperature excursion or product damage has occurred during transportation, this should be reported to the distributor. Vehicles and equipment used to distribute, store or handle medicinal products must be suitable for their use and equipped to prevent exposure that could affect product quality. Equipment used for temperature monitoring should be maintained and calibrated at regular intervals at least once a year. Where transportation is performed by a third party, the contract in place should encompass the requirements. Copyright Fresenius Kabi AG 10/18/

21 Operation - Transport damage Copyright Fresenius Kabi AG 10/18/

22 Fresenius Krav til transport 1 Presentasjon av Fresenius Kabi 2 GDP innen transport 3 Fresenius krav til transportselskap 4 Valg av transportør Copyright Fresenius Kabi AG 10/18/

23 Fresenius Krav til transportsselskap Alle våre leverandører velges etter en audit. Audit ivaretar at: Alle aspekt i henhold til GDP ivaretatt men med spesielt fokus på: Opplæring av sjåfører/faste sjåfører Minimalt bruk av terminaler Outsourcing (andre transportselskaper som kjører?) Lokaler Temperaturstyring Renhold Adgangskontroll Kvalitet på utstyr Transport Lane Risk assesment må foreligge fra transportøren på de destinasjonene som er foreslått. Etter at audit og transport lane risk assesment foreligger så foretas det en prøvetransport. Utfallet av denne avgjør om bytte. Copyright Fresenius Kabi AG 10/18/

24 Valg av transportør 1 Presentasjon av Fresenius Kabi 2 GDP innen transport 3 Fresenius krav til transport 4 Valg av transportør Copyright Fresenius Kabi AG 10/18/

25 Valg av leverandør Generellt så ønsker Fresenius Kabi spesialister innenfor GDP, slik at vi likeverdige partnere. Til internasjonal transport kreves store transportfirmaer med nettverk. FLY : SJØ: BIL: Stykkgods: Må ha en spesialist (GDP sertifisert) Anser som sikrere og følger konsernets valg av leverandør. Bare FTL, GDP Spesialist Desto mindre det bedre. Copyright Fresenius Kabi AG 10/18/

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27 Main Changes Old guideline open for interpretation new is much more detailed and in line with the GMP requirements. More specific re QMS, documentation, validation and qualification Focus on transportation and risk assessment/qualification of transport routes. GDP training of drivers Self inspection program to include GDP Increased control of outsourced activities (agreements /audit / review of performance) Defines Responsible Person s GDP responsibility Transport & storage requirements to be stated on shipping documents & outer / transport packaging Customers have right to request evidence of correct transport temperature (Increased use of temp. loggers) Impact: Adjust process, procedures and documentation both locally and centrally. Added cost & recourse within Supply Chain and QA. Copyright Fresenius Kabi AG 10/18/

28 1. Quality Management System Written procedures (Standard Operation Procedures) shall be available which specify the working methods and maintenance to be adopted in the warehouse and distribution areas. Written procedures shall describe the storage and distribution process and define the flow of materials and information through the operation. Records shall be kept for a minimum of 5 years after creation, or 1 year after expiry of the product, which ever is longest. Copyright Fresenius Kabi AG 10/18/

29 3. Premises and Equipment The storage areas shall: Have physically separated zones so that orderly, segregated storage is possible. (Not more than one batch at each location code). Be constructed to protect from temperature variations, dust, odour, moisture, animals, birds, vermin and insects (pest), direct sun-light and adverse weather conditions. Be fitted with a security system to prevent unauthorized entry. Incoming goods shall be physically separated from goods awaiting dispatch. Have a segregated area for quarantined, returned, damaged or rejected goods. Copyright Fresenius Kabi AG 10/18/

30 4. Documentation Good documentation is an essential part of the quality system. Written documentation prevent errors from spoken communication and permits the tracking of operations during distribution of medicinal products. Documentation comprises all written procedures, instructions, contracts, records and data, in paper or in electronic form. Documents should be retained for the period stated in national legislation but at least five years. Attention should be paid to using valid and approved procedures. Documents should be reviewed regularly and kept up-to-date. Version control should be applied to procedures. Records must include at least the following information: Date; Name of the medicinal product; Quantity received, supplied or brokered; Name and address of the supplier, Customer, Broker or Consignee, as appropriate; and Batch number. Copyright Fresenius Kabi AG 10/18/

31 5. Operation Qualification of Customers Wholesale distributors must ensure they supply medicinal products only to persons/companies in possession of a wholesale distribution authorization or authorized/entitled to supply medicinal products to the public. Checks and periodic rechecks may include: requesting copies of customer s authorizations according to national law, verifying status on an authority website, requesting evidence of qualifications or entitlement according to national legislation. Wholesale distributors should monitor and investigate any irregularity in the sales patterns of narcotics, psychotropic substances or other dangerous substances. Unusual sales patterns that may constitute diversion or misuse of medicinal product should be investigated and reported to competent authorities where necessary. Copyright Fresenius Kabi AG 10/18/

32 5. Operation Goods receipt All incoming deliveries shall be checked for contamination or damage. Any discrepancy or damage should be noted on the carrier delivery manifest. The driver must also sign the delivery note against the noted damage. Pictures should be taken of the damage for insurance claims If the product has a temperature logging device, this must be checked at receipt. Records for each delivery must be retained. These shall include the description of the goods, the physical condition, the quantity supplied, the supplier s batch number, the date of receipt and the date of expiry. Batches of medicinal products should not be transferred to saleable stock before assurance has been obtained in accordance with written procedures, that they are authorized for sale. Copyright Fresenius Kabi AG 10/18/

33 5. Operation - Storage Medicinal products and, if necessary, healthcare products should be stored separately from other products and should be protected from the harmful effects of light, temperature, moisture and other external factors. Particular attention should be paid to products requiring specific storage conditions. Periodic stock reconciliation shall be performed at regular intervals. Picking of shipments shall be in accordance with the FEFO principle of stock rotation. (First Expire - First Out) Any stock discrepancy shall be subjected to investigation. All stock shall be checked periodically for obsolete materials. Obsolete stock shall be transferred to the quarantine area and blocked for sale. Copyright Fresenius Kabi AG 10/18/

34 6. Complaints Complaints should be recorded with all the original details. A distinction should be made between complaints related to the quality of a medicinal product and those related to distribution. In the event of a complaint about the quality of a medicinal product, the manufacturer and/or marketing authorization holder should be informed without delay. Any product distribution complaint should be thoroughly investigated to identify the origin of or reason for the complaint. A person should be appointed to handle complaints and allocated sufficient support personnel. If necessary, appropriate follow-up actions (including CAPA) should be taken after investigation and evaluation of the complaint, including where required notification to the national competent authorities. Copyright Fresenius Kabi AG 10/18/

35 8. Self-inspection Self-inspections should be conducted in order to monitor implementation and compliance with GDP principles and to propose necessary corrective measures. A self-inspection programme should be implemented covering all aspects of GDP and compliance with the regulations, guidelines and procedures within a defined time frame. Self-inspections should be conducted in an impartial and detailed way by designated competent company personnel. All self-inspections should be recorded and the corrective and preventive actions (CAPA) should be documented and followed up. Copyright Fresenius Kabi AG 10/18/

36 Returns Returned goods should normally NOT be returned to saleable stock. Goods that have left the control of a distributor / wholesaler can only be returned to saleable stock if all of the following conditions are met: The goods are in their original, unopened containers, in good physical condition. It is positively known that the goods have NOT been exposed to adverse temperature conditions. They have been examined and assessed by an authorized person. This assessment shall take into account the nature of the product, any relevant special storage conditions and the time elapsed since it was issued. This is allowed by local legislation and procedure. Copyright Fresenius Kabi AG 10/18/

37 Falsified Medicinal Products What if falsified medicinal products is found in the distribution network..? Should be segregated immediately from other stock. Sealed and clearly labelled as not for sale. Competent Authorities and Marketing Authorisation holder of the original product should be informed immediately. Investigate! Copyright Fresenius Kabi AG 10/18/

38 Recall Fresenius Kabi will review any potential deviation with a product/batch to assess the impact on the end user and the product s regulatory status. A Recall Committee will decide the actions to be taken. Any Distributor or Wholesaler should be able to track, quarantine, and recall products on batch level. Their ability and agreement to achieve this must be confirmed within the contract agreement. Contact information on customers should be maintained to be the latest. Where the recall message requires stock to be quarantined, the product/batch must be stored in a segregated area and clearly labeled with its status. Copyright Fresenius Kabi AG 10/18/

39 Specific provisions for Brokers Definition: A broker is a person involved in activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person. Brokers are subject to a registration requirement. By definition, brokers do not procure, supply or hold medicines. Therefore, requirements for premises, installations and equipment as set do not apply. However, all other rules in Directive 2001/83/EC that apply to wholesale distributors also apply to brokers. Copyright Fresenius Kabi AG 10/18/

40 Take away Contact us regarding any Quality issue Inform about changes to local regulations Assist on audits when required Drive implementation of own QMS/Procedures Follow the product s temperature requirements for storage and transportation Ensure that you are able to track, quarantine, and recall products on batch level. Report complaints, counterfeit and adverse events Follow process for handling of returns Introduce regular Self-inspection of own operation Copyright Fresenius Kabi AG 10/18/