Standard Operating Procedure (SOP)

Transkript

1 Standard Operating Procedure (SOP) Co-funded by the European Commission Health and Consumer Protection Directorate General Public Health and Risk Assessment Directorate Grant Agreement No Manual European standard operating procedure (SOP) methodology reflecting European best practice within the area addressing the quality and safety of blood. Published by the Project Participants: DRK-BSDBH, Germany; HBRK, Belgium; NBT, Bulgaria; MOH, Cyprus; VFN, Czech Republic; EBS, Estonia; EFS, France; HNBT, Hungary; BTS, Iceland; NBTS, Ireland; ISS, Italy; IBT, Malta; IHBP, Poland; FMP, Romania; Sanquin, The Netherlands; SNBTS and NBS, United Kingdom. Editors: E. Seifried and C. Seidl, Frankfurt, Germany, Edition 1.0, 2007 English German

2 Publication notice: This manual has been developed by the participants of the EU-Q-Blood SOP Project co-funded by the European Commission, Health and Consumer Protection Directorate General, Public Health and Risk Assessment Directorate, Grant Agreement No ( ) The manual gives valuable information and guidance on the structure of documents related to quality management systems. The content of this manual will therefore by included in the EU co-funded project on developing common criteria and standards for the inspection of blood establishments. Further information on this manual including updated versions, national training courses or seminars organised by the project participants is available from the project Website of EUBIS (European blood inspection system) ( EuBIS European Blood Inspection System Co-funded by the EC Supported by the European Blood Alliance (EBA) Disclaimer: The content of this manual does not necessarily reflect the views of the European Commission. Neither the Commission nor any person acting on its behalf can be held responsible for any use that may be made of the information in this report. The editors and project participants assume no responsibility for the use to which this manual is made. ii

3 Red Cross Blood Donor Service Baden-Württemberg Hessia, University Hospital Frankfurt am Main, Germany Editors / Herausgeber; Erhard Seifried and Christian Seidl Edited in cooperation with the Project Participants / Herausgegeben gemeinsam mit den Projektteilnehmern DRK-BSDBH Germany (Project Coordinator) BTS - Iceland EBS - Estonia EFS - France FMP - Romania HBRK - Belgium HNBT - Hungary IBT - Malta IHBP - Poland ISS - Italy MOH - Cyprus NBS - United Kingdom NBT - Bulgaria NBTS - Ireland Sanquin - The Netherlands SNBTS - United Kingdom VFN - Czech Republic Deutsches Rotes Kreuz Blutspendedienst, Baden-Württemberg, Hessen (Red Cross Blood Donation Service) Landspitalinn Hàskòlasjuùkrahùs (Icelandic National University Hospital) Põhja-Eesti Verekeskus (North-Estonian Blood Centre) Etablissement Français du Sang (French Blood Establishment) Universitatea de Medicina si Farmacie "Victor Babes" Timisoara (University of Medicine and Pharmacy "Victor Babes" Timisoara) Het Belgische Rode Kruis (Belgian Red Cross) Orszàgos Vèrellàtò Szolgàlat (Hungarian National Blood Transfusion Service) Centru Nazzjonali ta't-trafuzjoni tad-demm (National Blood Transfusion Service) Instytut Hematologii I Transfuzjologii (Institute of Hematology and Blood Transfusion) Istituto Superiore di Sanitá Υπουργείο Υγείας της Κυπριακής Δημοκρατίας - Іατρικές Υπηρεσίες κσι Υπηρεσίες Δημόσιας Υγείας (Ministry of Health of the Republic of Cyprus - Medical and Public Health Services) The National Blood Authority (England and North Wales) НАЦИОНАЛЕН ЦЕНТЪР ПО ХЕМАТОЛОГИЯ И ТРАНСФУЗИОЛОГИЯ (National Center of Hematology and Transfusiology) The Blood Transfusion Service Board Stiching Sanquin Bloedvoorziening (Sanquin Blood Supply Foundation) Scottish National Blood Transfusion Service VSEOBECNÃ FAKULTNÍ NEMOCNICE V PRAZE and Vseobecná fakultní nemocnice (University Hospital of Prague) Advisory Board (Martin Gorham, Jeroen de Wit, Magdalene Letowska, Angus Macmillan Douglas). Supported by the European Blood Alliance (EBA) / mit Unterstützung der European Blood Alliance (EBA) Copyright iii

4 iv

5 PREFACE Ensuring the quality and safety of blood continues to be a major preoccupation within the framework of public health on the national and European level. The introduction of advanced technologies for the collection, processing and testing of blood during the last decade has resulted in extremely high quality and safety standards of blood and blood components. Increasing importance has been addressed to establish effective quality management systems for blood establishments. Those systems enable to optimise the control and monitoring of the complex and sophisticated processes covered by modern blood establishments. A key element of quality systems is to define a common quality policy, using standard process or operating procedures as an important tool for transposition. The objective of this manual is to set out a methodology for establishing such standard operating procedures (SOPs) based on the European Commission s directive requirements related to ensuring the quality and safety of blood. It is the result of a collaborative effort of representatives from 16 institutions participating in a project cofunded by the European Commission (Grant Agreement N ) within the framework of its Public Health Programme (Decision N 1786/2002/EC). Initiated and coordinated by the Red Cross Blood Donor Service Baden-Württemberg Hessia in Frankfurt am Main, Germany, this project aimed to develop a manual that would assist blood services to implement or improve their standard operating procedures and that would reflect, in the view of project participants, European best practice. It is hoped that this EU-SOP Manual will contribute to the understanding and management of quality processes in blood services and assist blood establishments in preparing for the inspection of their services related to the implementation of quality relevant elements required by European Union legislation. In this context, the manual includes a master SOP template and SOP examples illustrating the structure and the process to develop SOPs. The project coordinators herewith express their sincere appreciation to the participating institutions and their representatives, as well as to the team of advisors, in particular Martin Gorham, Dr. Jeroen dewit, and Angus Macmillan Douglas for their continued cooperation, collaboration and support throughout the life of this undertaking. Their willingness to share their expertise and experience at the national level on the use of the manual is gratefully acknowledged. The project participants also express their gratitude for the constructive cooperation with the representatives of the European Commission, Tapani Piha and Dr. Eduardo Fernandez-Zincke as well as the support of Frances Delaney. Finally, the project participants would like to acknowledge the support given by the European Blood Alliance at present and in sustaining the future dissemination of the Project s deliverables and the continual development of its ideas. v

6 This 1 st Edition of the manual is presented on behalf of the project participants. An electronic form can be ordered via the Project Website ( Prof. Dr. med. Erhard Seifried (Project Leader) Prof. Dr. med. Christian Seidl (Project Coordinator) On behalf of the Project Participants vi

7 VORWORT Die Sicherheit und Qualität von Blut und Blutbestandteilen ist von großer Bedeutung für das Öffentliche Gesundheitswesen auf nationaler und Europäischer Ebene. In den zurückliegenden Jahrzehnten hat die Einführung modernster Verfahren zur Gewinnung, Verarbeitung und Testung von Blut- und Blutbestandteilen zu einem hohen Qualitäts- und Sicherheitsstandards in diesem Bereich geführt. Eine zunehmende Bedeutung kommt der Etablierung von effektiven Qualitätsmanagementsystemen innerhalb der Blutspendeeinrichtungen zu. Diese Systeme ermöglichen die Überwachung der teilweise komplexen Tätigkeitsbereiche und Arbeitsabläufe. Ein wichtiger Bestandteil solcher Qualitätsmanagementsysteme ist die Festlegung von einheitlichen Qualitätszielen und die Beschreibung der hierfür erforderlichen Vorgehensweisen in Form von standardisierten Verfahrens- und Arbeitsanweisungen. Das vorliegende Handbuch soll einen praktischen Leitfaden geben für die Etablierung von Standardarbeitsanweisungen (engl. Standard operating procedure = SOP) in Blutspendeeinrichtungen basierend auf der durch die Europäische Kommission erlassenen Direktiven für Blut und Blutbestandteile. An der Ausarbeitung waren Experten von Blutspendeeinrichtungen sowie Gesundheitsministerien aus 16 EU-Mitgliedsländern beteiligt. Die Arbeitsgruppe war Teil eines durch die Europäische Kommission geförderten Projektes (Grant Agreement N ), das nach Initiative und unter Leitung des Blutspendedienstes Baden-Württemberg Hessen des Deutschen Roten Kreuzes in Frankfurt am Main durchgeführt wurde. Die Förderung hierfür erfolgte durch das Aktionsprogramm der Europäischen Gemeinschaft im Bereich der öffentlichen Gesundheit (Beschluss N 1786/2002/EG). Vorrangiges Ziel des Handbuches ist es zu einem besseren Verständnis von Qualitätsrelevanten Prozesses auf Ebene von Arbeitsanweisungen in Blutspendeeinrichtungen zuführen sowie Blutspendeeinrichtungen die Möglichkeit zu geben, bestehende Arbeitsanweisungen an die Anforderungen der Europäischen Direktiven anzugleichen. In diesem Zusammenhang kann der vorliegende Leitfaden Blutspendeeinrichtungen auch bei der Vorbereitung auf Inspektionen entsprechend den Vorgaben der Europäischen Direktiven genutzt werden. Hierzu versucht das Handbuch anhand von Muster-SOPs sowie mit praktischen Beispielen die Vorgehensweise zur Erstellung von Arbeitsanweisungen zu veranschaulichen. Die von den Projektteilnehmern auf Basis langjähriger Erfahrungen mit Qualitätsmanagementsystemen erarbeiteten Empfehlungen verstehen sich somit als Hilfestellung zur Umsetzung einheitlicher Europäischen Sicherheits- und Qualitätsstandard im Bereich von Blut und Blutbestandteilen wie sie in den Direktiven der Europäischen Kommission vorgegeben werden. vii

8 Die Projektkoordinatoren möchten sich bei allen mitwirkenden Institutionen, den Projektteilnehmern sowie den Mitgliedern des Advisory Boards, insbesondere Martin Gorham, Dr. Jeroen de Wit und Angus Macmillan Douglas, für die hervorragende Zusammenarbeit, den konstruktiven Gedankenaustausche und die fortwährende Unterstützung der Projektarbeit bedanken. Im Namen der Projektteilnehmer möchten wir uns weiterhin für die gute Zusammenarbeit mit den Vertretern der Europäischen Kommission, Tapani Piha und Dr. Eduardo Fernandez-Zincke sowie der Unterstützung durch Frances Delaney, bedanken. Unser Dank gilt auch der Unterstützung durch die European Blood Alliance in der bisherigen und zukünftigen Verbreitung der Projekt- Ergebnisse und der kontinuierlichen Weiterentwicklung der Projektinhalte. Die vorliegende 1. Ausgabe des Handbuches wird im Namen der Projektteilnehmer veröffentlich. Eine elektronische Version des Handbuches kann über die Homepage ( bestellt werden. Prof. Dr. med. Erhard Seifried (Projektleiter) Prof. Dr. med. Christian Seidl (Projektkoordinator) im Namen der Projektteilnehmer viii

9 Table of Contents / Inhaltsverzeichnis PREFACE... V VORWORT... VII MANUAL VERSION 1.0 ENGLISH / ENGLISCH...1 CHAPTER INTRODUCTION... 3 BACKGROUND... 3 PROJECT OBJECTIVES... 4 METHODOLOGY... 5 BACKGROUND SUMMARY... 7 CHAPTER 2. QUALITY PRINCIPLES OF DIRECTIVE 2002/98/EC AND 2005/62/EC...8 THE SOP MANUAL CHAPTER 3. DEVELOPMENT AND IMPLEMENTATION OF AN SOP IDENTIFY THE OBJECTIVE AND SCOPE OF THE SOP AND DRAFT A TITLE (STEP 1) IDENTIFY THE COMPETENT USER AND ASSIGN RESPONSIBILITY FOR WRITING (STEP 2) USING THE MASTER SOP TO WRITE AN SOP (STEP 3) DESIGN A FLOW CHART AND DESCRIBE EACH STEP OF THE WORK PROCESS (STEP 4) INITIATE DOCUMENT CHANGE CONTROL (STEP 5) PERFORM TRAINING OF THE SOP (STEP 6) CHAPTER 4. MASTER SOP AND EXAMPLES STANDARD OPERATING PROCEDURE TEMPLATE Section A: Purpose / Scope / Role Section B: Authorisation and change control Section C: Description of operating procedure Section D: Procedure for Non Conformance (Directive 2005/62/EC, Annex 9) Section E: Documentation Section F: Annex EUBIS MASTER SOP SPECIAL SOP FORMATS (TESTING AND EQUIPMENT) Standard test procedure (laboratory) using the EUBIS format Standard equipment procedures using the EUBIS format SOP EXAMPLES COVERING CRITICAL QUALITY ACTIVITIES Labelling and donor identification at collection site Blood group determination and compatibility testing Collection and processing of platelet apheresis concentrates Validation of temperature control areas for storage and transportation ANNEXES...94 ANNEX I TERMINOLOGY (DEFINITIONS) ANNEX II - PARTICIPATING INSTITUTIONS AND INDIVIDUALS ANNEX III - REFERENCES ANNEX IV - PROJECT-PUBLICATIONS ix

10 MANUAL VERSION 1.0 GERMAN / DEUTSCH KAPITEL EINFÜHRUNG HINTERGRUND PROJEKTZIELE ARBEITSPROGRAMM ZUSAMMENFASSUNG DER PROJEKTZIELE KAPITEL 2. QUALITÄTSGRUNDSÄTZE - DIREKTIVEN 2002/98/EG / 2005/62/EG Das SOP-Handbuch KAPITEL 3. ENTWICKLUNG UND IMPLEMENTIERUNG EINER SOP FESTLEGUNG DES AUFGABENBEREICHES DER SOP UND ENTWURF DES TITELS (SCHRITT 1) ERMITTLUNG EINES GEEIGNETEN MITARBEITER ZUR SOP-ERSTELLUNG (SCHRITT 2) EINSATZ DER MASTER-SOP ALS MUSTER ZUR ERSTELLUNG DER SOP (SCHRITT 3) ENTWURF EINES FLOW-CHARTS UND BESCHREIBUNG DER EINZELNEN SCHRITTE (SCHRITT 4) DURCHFÜHRUNG EINES GELENKTEN DOKUMENTENAUSTAUSCHES (SCHRITT 5) SCHULUNG DER SOP (SCHRITT 6) KAPITEL 4. MUSTER-SOP UND BEISPIEL SOPS MUSTER FÜR EINE STANDARD ARBEITSANWEISUNG Teil A: Zielsetzung / Anwendungsbereich / Aufgaben Teil B: Autorisierung und gelenkter Dokumentenaustausch ( change control ) Teil B: Freigabe und gelenkter Dokumentenaustausch ( change control ) Teil C: Beschreibung des Arbeitsprozesses Teil D: Verhalten bei Abweichungen (Direktive 2005/62/EG, Anhang 9) Teil E: Dokumentation Teil F: Anhang EUBIS MUSTER-SOP BESONDERE SOP FORMATE (LABORTESTUNG UND GERÄTE) Standard Test-SOP unter Verwendung des EUBIS-Formates Standard Geräte-SOP unter Verwendung des EUBIS-Formates SOPS ZU QUALITÄTSRELEVANTEN ARBEITSPROZESSEN Beschriftung und Spenderidentifikation im Rahmen der Blutspende Gewinnung und Herstellung von Apherese-Thrombozytenkonzentraten Validierung der Temperaturüberwachung für Lagerung und Transport von Blutprodukten ANHANG ANHANG I BEGRIFFSBESTIMMUNGEN ANHANG II TEILNEHMENDE INSTITUTIONEN UND PERSONEN ANHANG III - REFERENZEN ANHANG IV - PROJEKT-BEZOGENE PUBLIKATIONEN x

11 Manual Version 1.0 English / Englisch 1

12 2

13 CHAPTER 1 Introduction This manual setting out a European standard operating procedure (SOP) methodology is the outcome of a project entitled EU-Q-Blood SOP. 1 The project was co funded by the European Commission under its Programme of Community action in the field of public health 2, which identified the enhancement of the quality and safety of blood and blood components as one of its actions and support measures. This SOP manual, developed by a consortium of blood establishments having considerable expertise in quality management systems, reflects, in the view of the project participants, European best practice for developing high standards of quality and safety for the collection, processing, storage and distribution of blood and blood components. Its aim is to provide the tools by which a blood establishment can build up its own standard operating procedures (SOPs), as well as provide a logical framework which hopefully can be used by all institutions in a variety of different logistical and functional situations. Background In 2002, the European Union established a legislative foundation for setting a high level of quality and safety of human blood and blood components with the adoption of Directive 2002/98/EC 3. This was followed in 2004 and 2005 by three European Commission Directives setting out the technical implementing measures for issues that are identified in that Directive. The first deals with certain technical requirements for blood and blood components (2004/33/EC 4 ), the second with traceability and the notification of serious adverse reactions and events (2005/61/EC 5 ) and the third with standards and specifications related to a quality system for blood establishments in the European Union (2005/62/EC 6 ). Directive 2002/98/EC places a major obligation on Member States and their identified competent authorities to carry out regular inspections and control of all blood establishments on their territory (Article 8). In addition, it requires all blood establishments to establish and maintain a quality system based on the principles of good practice (Article 11). 1 Grant Agreement Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September2002 adopting a programme of Community action in the field of public health ( ). OJ L271, , p.1 3 Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. Official Journal of the European Union, L33, 8/02/2003, p Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components. Official Journal of the European Union, L91, 30/03/2004, p Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events. Official Journal of the European Union, L256, 1/10/2005, p Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments. Official Journal of the European Union, L256, 1/10/2005, p.41. 3

14 Recognizing this obligation on blood establishments to implement quality systems, the European Commission in its 2004 work plan included as one of its priority actions to support the development and implementation of quality management programmes to improve the safety of blood donations to be carried out in the Community. 7 The subsequent Call for Proposals 8 specified inter alia that in the area of blood, priority would be given to the development of tools that would provide practical guidance on how to install and maintain quality systems in blood establishments in the Member States (Section 2.2.4). In response to this Call, a consortium of 16 blood establishments with considerable expertise in quality management systems was brought together to develop a project proposal for submission to the European Commission. Coordinated by the Red Cross Blood Donor Service (Deutsches Rotes Kreuz Blutspendedienst) of Baden-Württemberg in Germany, the participating blood establishments involved EU member, acceding or European Free Trade Association (EFTA) countries from Belgium (BE), the Czech Republic (CZ), the Federal Republic of Germany (DE), Estonia (EE), France (FR), the Republic of Ireland (IE), Italy (IT), Cyprus (CY), Hungary (HU), Malta (MT), The Netherlands (NL), Poland (PL), the United Kingdom (UK), Iceland (IS), Bulgaria (BG) and Romania (RO) (Listed in Annex II). The Consortium, fully aware of the importance of quality management systems in blood services, recognised that standard operating procedures SOPs are a key element in the implementation of good practice and represent the basis of the classical quality management systems document hierarchy. They provide a series of instructions to carry out an activity in order to demonstrate compliance with procedures. Therefore, the Consortium decided to submit a proposal to the Commission for co-funding to establish a methodology for the preparation of SOPs in blood establishments in the European Union. Project Objectives The specific objectives of the EU-Q-Blood-SOP Project were to: 1. assess the existence of SOP manuals and guidelines currently used in the 16 blood services involved in the project in order to identify (a) international and national SOP manuals already in place and (b) the current inspection practice; 2. develop a manual to assist blood establishments to develop and implement their own SOPs; 3. test this new SOP methodology among the partner institutions; 4. distribute this manual to (a) the participating blood establishments and (b) to disseminate the results to any interested blood establishments throughout the /192/EC: Commission Decision of 25 February 2004 adopting the work plan for 2004 for the implementation of the programme of Community action in the field of public health (2003 to 2008), including the annual work programme for grants (Text with EEA relevance). Official Journal of the European Union L 60, , p Community action in the field of public health ( ). Work plan

15 European Union, acceding or EFTA states using the participating blood establishments as national contact points. Methodology Following submission of the project proposal to the European Commission, its approval, and the completion of project negotiations, the Project coordinators prepared a survey questionnaire designed to find out the current status of SOPs, their structures and any manuals or regulations already in place in the various participating institutions and countries. It was divided into four different sections specifically addressing questions related to (i) basic validation, (ii) principal management requirements, (iii) areas of work, where SOPs are in place, i.e. donor recruitment, testing, management, logistics, etc. and (iv) the way that risks are identified and managed. Specific questions sought the identification of international and national SOP manuals already in place [e.g. American Association of Blood Banks (AABB)], being used or legally required. One question sought to determine whether the blood establishments have been inspected by government authorities and at what intervals. The awareness of inspections as required by Directive 2002/98/EC where relevant was also solicited. Based on the results of the questionnaire, differences and commonalities in the approach to quality management and specific related aspects were identified and summarized in a survey report ( It identified some of the perceived high risk areas in blood collection, preparation, laboratory testing, storage and distribution with 7 of 15 (47%) participating blood establishments of the view that their present SOP system required change in the light of the European blood legislation, These were mainly participants from the Member States that joined the EU in 2004 and from the Applicant Countries (Bulgaria and Romania joined the EU in 2007). Four of 15 (27%) participants (2 from Applicant Countries and 2 from the 15 pre-2004 EU Member States) indicated that their blood establishments were not inspected by governmental authorities. The responses also led to the identification of critical areas in transfusion medicine that needed to be addressed by the project s working groups. Following compilation of the responses to the questionnaire, a start-up meeting of the project participants was convened at which the project s work plan was reviewed, the survey results discussed and agreed, and four working groups established to address the entire range of blood establishment responsibilities from the donor interview to logistic and managerial responsibilities in blood supply. Nominated experts from each of the participating blood establishments were assigned to each working group and in January 2006 began their work. The structure of the working groups and their area of coverage are presented in Table

16 Table 1.1. Working group Structure Working group 1 (WG 1): Donor recruitment and production The Netherlands (Leader), Cyprus, Iceland, Italy SOP-Topic Test site Areas of Interest and Risk identified Identification of donors and labelling Cyprus - Blood Collection - Donor Identification - Donor acceptability/selection/interview - Disinfection and Sterility of blood components - Labelling and Identification Working group 2 (WG 2): Testing (Immunohaematology, Molecular Diagnostics) United Kingdom (Leader), Belgium, Bulgaria, Romania SOP-Topic Test site Areas of Interest and Risk identified Blood Group determination and compatibility testing in emergency Bulgaria - Testing of blood groups and labelling (Rhesus variants/abo) - Testing in emergencies - Donor registries (could be linked to Section IV) Working group 3 (WG 3): Special blood component production Germany (Leader), Czech Republic, Hungary, Malta, Poland SOP-Topic Test site Areas of Interest and Risk identified Processing of platelet apheresis concentrates Malta - Apheresis Concentrates (Platelets) - Pooled Platelet Concentrates - Granulocyte Concentrates - Paediatric Units Working group 4 (WG 4): Logistics, storage, distribution and management France (Leader), Estonia, Ireland, Scotland SOP-Topic Additional Guidelines Areas of Interest and Risk identified Validation of temperature control areas for storage and transportation of blood components Change control of documents - Transportation and temperature control - Validation of equipment - Central blood stock management and distribution - Blood component release and/or issuing - Storage and transport related to production 6

17 Participating blood establishments agreed on the common quality elements for SOPs (Chapter 3). They emphasized that while the SOP level can be sufficient to describe work processes, they have to be incorporated in a quality management system in accordance with the relevant requirements of Directive 2002/98/EC (Article 11(1) and Annex I Part B) (Figure 1.1). In several cases, blood establishments are also required to follow additional requirements according to specific regulations defined by good manufacturing practice (GMP) and/or the standards of the International Organisation for Standardisation (ISO) for setting-up a quality manual (linked to ISO) or site-master-file (linked to GMP). In these cases it will be advisable to cross-reference the directive requirements to those standards in order to harmonize the quality management system. Background Summary The aim of the EU-Q-Blood-SOP project was not to provide an operating procedure to be used in an institution, but rather to provide the tools by which one can build a standard operating procedure (SOP). The resulting product is an SOP-manual that provides a methodology for creating an SOP comprising the basic quality elements. It is intended to set out a practical template aimed at assisting blood establishments prepare for governmental inspections as required by Directive 2002/98/EC. It could also be used to adapt existing procedures to comply with current EU requirements. This SOP methodology comprises precise quality requirements, requisites and quality terms linked to the EU Directives and is based on GLP/GMP-standards that have to be specified (filled-out) in order to complete the documents. These quality requirements are presented in a modular fashion, in order to tailor the SOPs to meet local circumstances. The Manual aims to deliver practical guidance on the basic structure for preparing Standard Operating Procedures (SOPs). Example SOPs, drafted by the working groups focusing on selected areas that have been chosen from the areas of highest risk, are presented in Chapter 4. These examples are intended to assist those who are aiming to adapt their local SOPs using the guidelines given in this manual. The aim is to provide a logical framework which can be used by all institutions in a variety of different logistical and functional situations. 7

18 CHAPTER 2. Quality principles of Directive 2002/98/EC and 2005/62/EC Directive 2002/98/EC 3 requires that each blood establishment must provide specified information to the competent authority in order to be designated, authorised, accredited or licensed [Article 5(1)]. The required information related to a quality system is set out in its Annex I, Part B and has to include: 1) Documentation, such as an organisation chart setting out staffing responsibilities and reporting relationships; 2) Documentation such as a site master file or quality manual describing the quality system based on the principles of good practice; 3) Number and qualifications of personnel; 4) Hygienic provisions; 5) Premises and equipment; 6) List of standard operating procedures (SOP) for - Donor recruitment - Retention and assessment of donors - Processing and testing - Distribution and recall of blood and blood components - Reporting and recording of serious adverse reactions and events. Directive 2005/62/EC 6 sets out the standards and specifications related to a quality system for blood establishments, based on Directive 2002/98/EC, which will help to ensure the safety of blood throughout the European Union. Recital 3 states that A quality system for blood establishments should embrace the principles of quality management, quality assurance, and continuous quality improvement, and should include personnel, premises and equipment, documentation, collection, testing and processing, storage and distribution, contract management, non-conformance and self-inspection, quality control, blood component recall, and external and internal auditing. (refer to Directive 2005/62/EC) A quality system for blood establishments is considered to be a key element in the implementation of good practice. A quality management system is used for the purposes of compliance with regulations and guidelines. It should ensure a systematic approach towards quality and the implementation and maintenance of a quality system. It should involve all persons and 8

19 processes in the blood establishment (Annex 1.1) and lead to a system for the evaluation of processes and to continuous quality improvement. There are no absolute criteria for framing the quality management system. In general, it comprises a number of tools defined by the individual institution, in order to allow for the flexibility to adjust to various regulations and guidelines. In meeting the requirements of Directive 2005/62/EC, individual Member States must take into account their own additional specific regulations and guidelines. According to Directive 2005/62/EC quality systems for blood establishments should be based on good practice (GP). In order to ensure the highest quality and safety for blood and blood components, guidance on good practice should be developed to support the quality system requirements for blood establishments taking fully into account the detailed guidelines referred to in Article 47 of Directive 2001/83/EC so as to ensure that the standards required for medicinal products are maintained. (Recital 5) Such good practice guidelines for blood establishment are to be developed by the European Commission (Article 2, Para 2) taking fully into account the principles and guidelines of Good Manufacturing Practice (GMP) (see terminology, Annex I) Annex I requires that the quality system ensures that all critical processes are specified in suitable instructions. The system must be reviewed by management at regular intervals to verify its effectiveness and measures introduced if deemed necessary (Section 1.1 Para. 3). In order to fulfil these requirements, a blood establishment needs to establish a documentation system. It should be organized at different levels of document responsibility with the top level being those legislative instruments (e.g. legislation and laws), regulations and guidelines the individual blood establishment has to follow (refer to chapter 2, Figure 2.1). These regulations should be incorporated into the quality management system and be reflected throughout the entire quality documentation system. A description of the quality system itself should be presented in the document level directly below. Documentation on the manual and/or site-master file (See Definitions) has to be in accordance with Article 11(1) of Directive 2002/98/EC 9. In addition, standard operating procedures (SOPs) have to be prepared by the blood establishment 10. These SOPs are an important part of the quality system and have to cover all the establishment s critical activities. 9 Annex I, Part B, indent 2 10 Annex I, Part B, indent 6 9

20 In preparing the site master file and the SOPs, the blood establishment needs to address the main aspects of the quality system standards and specifications set out in the Annex of Directive 2005/62/EC: - General Principles (Part 1) - Personnel and Organisation (Part 2) - Premises (Part 3) - Equipment and Materials (Part 4) - Documentation (Part 5) - Blood collection, testing and Storage (Section 6), including 6.1 Donor Eligibility, 6.2 Collection, 6.3 Laboratory testing, 6.4 Processing and validation, 6.5 Labelling, 6.6 Release of blood and blood components - Storage (Section 7) - Contract Management (Part 8) - Non-Conformance (Part 9), including 9.1 Deviations, 9.2 Complaints, 9.3 Recall, 9.4 Corrective and preventive actions - Self-inspection, audits and improvements (Part 10) In order to ensure standardised practice across the blood establishment, it is advisable to introduce general procedures to describe common processes. These procedures should cover operational activities (e.g. sample receipt, collection, etc.), support services (e.g. human resources, etc.) and management processes (e.g. objective setting, nonconformances, internal audit, etc.). The Quality Manual or Site Master File should be established according to Annex I Part B, and Article 11(1) of Directive 2002/98/EC. They are the official documents describing the overall function and quality policy of the blood establishment as required by the Annex of Directive 2005/62/EC (see above Part 1 Part 10). The SOP Manual This manual provides a methodology for creating an SOP which comprises the basic quality elements. It is intended to set out a practical template for the preparation of SOPs and aims to assist blood establishments in preparing for governmental inspections under blood legislation. It could also be used to adapt existing procedures to comply with current EU requirements. 10