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Statutaire Dag VZA 19022000

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    1. 7/09/06 Quality in pharmacy 1

    2. 7/09/06 Quality in pharmacy 2 Content 1. Organigram :who are we and what do we do? 2. General introduction of quality 3. Theoretical aspects 4. Structure of the quality management system 5. Practical implementation 6. Conclusion

    3. 7/09/06 Quality in pharmacy 3 1. Introduction

    4. 7/09/06 Quality in pharmacy 4 1.2. Organigram of the pharmacy

    5. 7/09/06 Quality in pharmacy 5 Production unit Non sterile preparations : capsules, ointments, solutions (e.g. antiseptic solutions), Sterile preparations : total parenteral nutrition, eye drops, infusion solutions, cytotoxic drugs, Repackaging in unit doses of drugs Staff : 6 pharmacists 2 laboratory technicians 16 pharmacy assistants

    6. 7/09/06 Quality in pharmacy 6 Distribution and clinical pharmacy Purchase, storage and distribution of commercially available medicines Information on dosage, stability and pharmacotherapy Follow up of guidelines (e.g. for the use of antibiotics, antimycotics, ) Clinical pharmacists on different wards : pediatrics, intensive care, geriatics Projects : risk management, electronic presciption Clinical trials Staff: 9 pharmacists 20 assistants 4 secretaries 15 logistic co-operators 1 clinical trials administration

    7. 7/09/06 Quality in pharmacy 7 Medical devices, implants Purchase, storage and delivery of medical devices and implants Product information , tarification Staff : 2 pharmacists 9 administrative co-operators

    8. 7/09/06 Quality in pharmacy 8 Central sterilisation unit Cleaning, desinfecting and sterilisation of surgical instrumentation Packaging and sterilisation of dressings 3 locations : steam, Etox and H2O2 sterilisation Staff : 1 pharmacist 4 nurses 42 technicians

    9. 7/09/06 Quality in pharmacy 9 2. Organigram of the pharmacy Definition of quality: to achieve certain requirements or specifications Key of a quality system: say what you do in the standard operating procedures and prove that you do what you say by quality registrations

    10. 7/09/06 Quality in pharmacy 10 How to achieve quality? Adequate infrastructure and equipment Well trained staff Good policy Development of your own quality management system

    11. 7/09/06 Quality in pharmacy 11 Why do we want quality? Organisation : long term positive cost/benifit ratio Clinical trials Customer (nurses, physicians, patients,..) requirements = right drug for the right patient in the right dosage on the right time by the right route of administration = correct assembled and labelled surgical instrumentation, sterilised by the right method (steam, EtOx, ..)

    12. 7/09/06 Quality in pharmacy 12 Principles of a quality system Customer oriented organisation Continuing improvement by Verification and release (double check) Internal audits Reporting of non conformities and complaints Plan-Do-Check-Act (PDCA or Deming Circle)

    13. 7/09/06 Quality in pharmacy 13

    14. 7/09/06 Quality in pharmacy 14 Aim Consequently deliver products that fulfill the requirements of the customer and fulfill the local regulations To have satisfied customers , this can be achieved by continuing improvement and prevention of non conformities

    15. 7/09/06 Quality in pharmacy 15 Choice of the quality system ISO 9001:2000 International Organisation for Standardisation = network of national standardisation institutions with a central secretariat in Switserland ( ISO 9000 family : ISO 9000:2000 : Quality management systems Basic principles ISO 9001:2000 : Quality management systems - Requirements ISO 9004:2000 : Quality management systems Quidelines for performance improvement ISO 10011 : Quidelines for quality and environment audits

    16. 7/09/06 Quality in pharmacy 16 Choice of the quality system ISO 9001:2000 General, well known quality management system Experience and know how in 7 other pharmacy hospitals

    17. 7/09/06 Quality in pharmacy 17 Situation in University Hospital Gent (UZG) Pharmacy and central sterilisation unit are ISO 9001:2000 certified since July, 2002 Scope : ordering, receiving, storage and distribution of drugs, medical devices and implants preparation of cytotoxic drugs, TPN, non sterile and sterile preparations washing, desinfecting, assembling and sterilisation with steam and EtOx of surgical instruments

    18. 7/09/06 Quality in pharmacy 18 ISO 9001:2000 certificates in UZG Since february 2004 : purchase department of the hospital Other departments : Drug Research Unit May 2006 : Medical Oncology Day Hospital

    19. 7/09/06 Quality in pharmacy 19 ISO 9001:2000 norm ISO 9001:2000 standard : divided into 8 chapters : important chapters are : 4. Quality management system 6. Management of means 7. Realisation of the product 8. Measurement, analysis and improvement

    20. 7/09/06 Quality in pharmacy 20 ISO 9001:2000 standard 4. Quality management system : General requirements (4.1): Process description Control, measure and analyse of the process Continuing improvement of the process Documentation requirements (4.2): Quality manual Stabdard operating procedures (SOP) Quality registrations Documentation control (who authorises the procedure, actualisation of the procedure, management of changes to a procedure, announcement of changes, control of copies and expired documents)

    21. 7/09/06 Quality in pharmacy 21 ISO 9001:2000 standard 6. Management of means Availability of financial means (6.1) Staff (6.2) : Capacities Training and evaluation Registration of qualification and training Infrastructure (6.3) (building, working area, equipment, transport, ) Work environment (6.4)

    22. 7/09/06 Quality in pharmacy 22 ISO 9001:2000 standard 7. Realisation of the product Determine product requirements (7.2.1) Review product requirements (7.2.2) Purchase (7.4) : Determine acceptation criteria for delivered goods (equipment, packaging materials, raw materials, ) Requirements for qualification of personnel Check if the deliverd goods are conform the acceptation criteria Identification and tracebility (7.5.3)(implants, preparations) Maintenance of the product (7.5.5) (e.g. packaging, storage of sterile products)

    23. 7/09/06 Quality in pharmacy 23 ISO 9001:2000 standard 7. Realisation of the product Control of monitoring and measuring instruments (7.6) Calibration

    24. 7/09/06 Quality in pharmacy 24 ISO 9001:2000 standard 8. Measurement, analysis and improvement Follow up of customer satisfaction (8.2.1) Internal audits (8.2.2) Follow up of products and processes (8.2.3 and 8.2.4) Control of non conformities (8.3) Continuing improvement by (8.5): Corrective actions (8.5.2) e.g. after non conformity, complaint, or internal audit Preventive actions (8.5.3) e.g. purchase policy, education of staff

    25. 7/09/06 Quality in pharmacy 25 Basisstructuur : piramide

    26. 7/09/06 Quality in pharmacy 26 Basisstructuur Level 1 : quality manual Mission and policy of the pharmacy Covers all the chapters of the ISO standard Level 2 : SOP General procedures applicable for the whole department, e.g. staff, internal audits, purchase Level 3 : Work instructions Short procedures, typical for one unit e.g. how to work with a steam sterilisator Level 4 : Documentation forms, manuals of equipment, books,

    27. 7/09/06 Quality in pharmacy 27 SOP = standard operating procedure Describes the process (scope, method, responsibilities) Signed for agreement by the responsible Validation of the procedure by the quality manager

    28. 7/09/06 Quality in pharmacy 28 ISO 9001:2000 standard Written general SOPS necessary for: Management of documents Management of quality registrations Internal audits Control of non conformities Corrective actions Preventive actions Calibration Purchase Preparations (sterile and non sterile preparations) Cytotoxic drugs (preparation, safety measures, waste control, stability, light protection)

    29. 7/09/06 Quality in pharmacy 29 Implementatie Lay-out for SOP Quality manual Write necessary SOP (say what you do) Qualification registration for staff Calibration and maintenance of equipment

    30. 7/09/06 Quality in pharmacy 30 Preparations SOP describes the proces from the ordering of the raw materials until the quality control of the finished product and delivery of the product to the customer Quality requirements for raw materials Quality requirements for release of the finished product Responsibilities Software Proaz II : on line registration of weight, in proces controls, release of raw materials and finished product

    31. 7/09/06 Quality in pharmacy 31 Preparations : good practice Standard preparations in large quantities : - uniformity of content (QC laboratory) Capsules : uniformity of mass on 15 capsules Ointments : homegeneity Sterile preparations : incubation for sterility testing Every preparation is double checked by a pharmacist Written protocols for most of our preparations (method description, raw materials, packaging material, storage condition, shelf life, )

    32. 7/09/06 Quality in pharmacy 32 Treatment of non conformities SOP : What should be done ? Who should do what (responsibilities) Quarantine : marked space for non conform products Registration of product, batch number, number of vials, date and signature, reason for quarantine Follow-up if products are collected or destroyed and register

    33. 7/09/06 Quality in pharmacy 33 Internal audits = internal investigation to see if the quality systems works well Yearly for every proces Auditplan Trained, independent auditors Written report with findings and recommandations List with standard questions for each proces Registration of follow up of actions

    34. 7/09/06 Quality in pharmacy 34 Staff SOP Job description Training and education Evaluation Resposibilities Qualification registration

    35. 7/09/06 Quality in pharmacy 35 Qualification registration In QMS : tasks can only be performed by a well trained person For each person : qualification registration, for each task the level of competence is mentioned (beginner, trained,expert)

    36. 7/09/06 Quality in pharmacy 36 Calibration SOP : Equipment : balance, sterilisator, HPLC, thermometer, LAF, Frequency of calibration Registration of calibration and status Date of calibration, name, signature Specifications Report of calibration

    37. 7/09/06 Quality in pharmacy 37 Maintenance of equipment Should be done regularly and should be traceble: Logbook for each equipment Written report necessary E.g. refrigirators, sterilisators, sealing equipment

    38. 7/09/06 Quality in pharmacy 38 Added value : Try to avoid mistakes (right first time), mistakes that are expensive and dangereous in a medical setting Written SOP : faster and uniform training of new personnel Long term : cost effective by fault reduction Cave : Each SOP means a lot ofadministration so only write SOP if it gives an added value

    39. 7/09/06 Quality in pharmacy 39 Thank you for your attention