Vergleich der Versionen von Kapitel 1 des EU-GMP-Leitfaden (Oktober 2012) 01 July November Januar 2013 Kommentar Maas & Peither

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1 Chapter 1 Quality Management Chapter 1 Quality Management System Chapter 1 Pharmaceutical Quality System Principle The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company s suppliers and by the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice, Quality Control and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance system should be adequately resourced with competent personnel, and suitable and sufficient The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the relevant Marketing Authorisation(s) and do not place patients at risk due to inadequate safety, quality or efficacy. An effective quality management system is essential to the realisation of this quality objective reliably, the manufacturer should establish, document, and implement a comprehensively designed and correctly implemented Quality Management System incorporating Good Manufacturing Practice, Quality Assurance, Quality Control and Quality Risk Management principles. The attainment of this quality objective is the responsibility of the organisation s senior management and requires their leadership and the active participation supported by the commitment of staff in many different departments and at all levels within the company, together with the proper The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation or Clinical Trial Authorisation, as appropriate and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company s suppliers and by its distributors. To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented Pharmaceutical Quality System1 incorporating Good Manufacturing Practice and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Pharmaceutical Quality System should be adequately resourced with In diesem Abschnitt gibt es geringfügige Änderungen gegenüber der Version von Der Entwurf wurde in der finalen Version nur wenig berücksichtigt. Der Begriff Pharmaceutical Quality System wird erstmals eingeführt 2012 Maas & Peither AG, Karlstrasse 2, Schopfheim, Deutschland Seite 1 von 30

2 premises, equipment and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Qualified Person(s). The basic concepts of Quality Assurance, Good Manufacturing Practice, Quality Control and Quality Risk Management are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products. supervision of the company s external suppliers of materials and services. The scope of the guidance in this chapter applies to the technology transfer, manufacture and control and discontinuation of a product. Manufacturers should take account of GMP during the development of products, however this guideline does not specifically apply to the development of a product other than the expectations applicable to the manufacture and control of Investigational Medicinal products. ICH Q10 as transposed in full into EU GMP as Annex 21 of the guide, provides an example of a pharmaceutical quality system designed for the entire product lifecycle and therefore goes beyond the expectations of this chapter. It should be noted that application of Annex 21 to the entire product life cycle by a company is optional but its use should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development, technology transfer and manufacturing activities, and is therefore supported by Authorities. competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Qualified Person(s). The basic concepts of Quality Management, Good Manufacturing Practice and Quality Risk Management are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products Maas & Peither AG, Karlstrasse 2, Schopfheim, Deutschland Seite 2 von 30

3 Quality Assurance Quality Management System/ Quality Assurance Pharmaceutical Quality System 1 1 Art 6 of Directives 2003/94/EC and 91/412/EEC require manufacturers to establish and implement an effective pharmaceutical quality assurance system. The term Pharmaceutical Quality System is used in this chapter in the interests of consistency with ICH Q10 terminology. For the purposes of this chapter these terms can be considered interchangeable. 1.1 The Quality Management System should: i) Achieve Product Realisation To establish, implement and maintain a system that allows the delivery of products with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities (including compliance with approved regulatory filings) and other internal and external customers. ii) Establish and Maintain a State of Control To develop and use effective monitoring and control systems for process performance and product quality, thereby providing assurance of continued suitability and capability of processes. Quality risk management can be useful in identifying the monitoring and control Der Entwurf wurde in der finalen Version nicht berücksichtigt Maas & Peither AG, Karlstrasse 2, Schopfheim, Deutschland Seite 3 von 30

4 systems. iii) Facilitate Continual Improvement To identify and implement appropriate product quality improvements, process improvements, variability reduction, innovations and quality management system enhancements, thereby increasing the ability to fulfil quality needs consistently. Quality risk management can be useful for identifying and prioritising areas for continual improvement. 1.1 Quality Assurance is a wideranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors outside the scope of this Guide. 1.7 Quality Assurance is a wideranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors outside the scope of this Guide. 1.1 Quality Management is a wideranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Management therefore incorporates Good Manufacturing Practice. Dadurch, dass nun Quality Management verwendet wird, erübrigt sich der letzte Halbsatz. Denn Quality Management ist grundsätzlich umfassender als Quality Assurance. 1.2 The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities necessary to ensure confidence that 1.2 GMP applies to the lifecycle stages from the manufacture of investigational medicinal products, technology transfer, commercial manufacturing through to product Dieser Abschnitt ist neu in die finale Version aufgenommen worden. Es wird damit die Verbindung zur ICH Q10 Richtlinie 2012 Maas & Peither AG, Karlstrasse 2, Schopfheim, Deutschland Seite 4 von 30

5 the product will meet its intended specifications for quality and purity. 1.4 The size and complexity of the manufacturer s activities should be taken into consideration when developing the quality management system or modifying an existing one. The design of the quality management system should incorporate appropriate risk management principles. Some aspects of the quality management system can be companywide and others site-specific discontinuation. However the Pharmaceutical Quality System can extend to the pharmaceutical development lifecycle stage as described in ICH Q10, which while optional, should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities. ICH Q10 is reproduced in Part III of the Guide and can be used to supplement the contents of this chapter. 1.3 The size and complexity of the company s activities should be taken into consideration when developing a new Pharmaceutical Quality System or modifying an existing one. The design of the system should incorporate appropriate risk management principles including the use of appropriate tools. While some aspects of the system can be company-wide and others sitespecific, the effectiveness of the system is normally demonstrated at the site level. verdeutlicht. Es ist eine bedeutende Änderung wenn nun vom Lebenszyklus Modell ausgegangen wird. Auch und gerade weil nun auch die Entwicklungsphasen GMP, wenn auch im reduzierten Umfang, anwenden sollten. Dieser Absatz ist neu ggü. der Version 2008 und präzisiert ggü. dem Entwurf. Es wird detailliert ausgeführt, dass auch geeignete Tools implementiert werden müssen. Ebenso ist bedeutsam, dass die Effektivität auf Standortebene nachgewiesen werden muss. Dadurch kann bei Inspektionen von Standorten dieser Effektivitätsnachweis gefordert werden Maas & Peither AG, Karlstrasse 2, Schopfheim, Deutschland Seite 5 von 30

6 The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that: 1.8 The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that: 1.4 A Pharmaceutical Quality System appropriate for the manufacture of medicinal products should ensure that: (i) Product realisation is achieved by designing, planning, implementing, maintaining and continuously improving a system that allows the consistent delivery of products with appropriate quality attributes; Dieser Absatz wurde neu aufgenommen und verdeutlicht die Vernetzung der Produkt Herstellung (ii) Product and process knowledge is managed throughout all lifecycle stages; Das Wissensmanagement muss über den gesamten Lebenszyklus implementiert sein. (i) medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice; (i) medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice; (iii) Medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice; Keine Änderungen (ii) production and control operations are clearly specified and Good Manufacturing Practice adopted; (ii) production and control operations are clearly specified and Good Manufacturing Practice adopted; (iv) Production and control operations are clearly specified and Good Manufacturing Practice adopted; Keine Änderungen (iii) managerial responsibilities are clearly specified; (iii) managerial responsibilities are clearly specified; (v) Managerial responsibilities are clearly specified; Keine Änderungen 2012 Maas & Peither AG, Karlstrasse 2, Schopfheim, Deutschland Seite 6 von 30