Experience responsibility. Pharmaceuticals & Biotechnology. GMP Compliance

Transcription

1 Experience responsibility Pharmaceuticals & Biotechnology GMP Compliance

2 Everything you need for GMP Compliance! Systems, processes, personnel and documentation that affect the product quality and product safety of pharmaceuticals, active agents, and medical devices must meet the requirements of the QM/GMP rules. A variety of rules are unavoidable in QM/GMP compliance, starting with the EC GMP Guide / EN ISO 13485, continuing with the stipulations of the FDA as per 21 CFR up to national legislation like AMBO 2009 (AT) or AM- WHV (DE). GMP conformity plays a central role in many industrial sectors: Pharmaceuticals industry Biotechnology Medical devices Storage and transport Active ingredient production Quality control labs / R&D labs Hospitals / institute pharmacies Blood and tissue banks Pharmaceutical Development, Quality by Design (QbD) Quality by Design (QbD) is a new type of knowledge and risk-based approach for pharmaceutical product and process development. Through the definition of the critical product and process parameters (cqa, cpp), the establishment of a design space as well as its verification by means of, for example, DoE Methodology & Experiments, can regulate manufacturing processes in a more flexible way. A real time release is also possible through the use of a control strategy, by means of PAT tools, for example. The implementation of customised QbD approaches facilitates an increased product and process understanding as well as an efficiency increase during production. VTU provides support in QbD-based development processes and their implementation in new manufacturing processes or alternatively their integration in existing GMP-compliant manufacturing processes: Definition of the critical product and process parameters (cqa, cpp) Implementation of customised risk management Creation and moderation of risk analyses Statistical experiment planning, Design of Experiments (DoE) Development of the design space Establishment of the scale down model Establishment of a QbD-based control strategy for the active ingredient and/or pharmaceutical Preparation of technical reports (source documents) Preparation and revision of SOPs

3 VTU offers GMP services as part of the qualification and validation of plants, computer systems and processes in the pharmaceuticals industry and in medical technology, consulting for the introduction of GMP compliant processes in engineering, production, laboratories and quality assurance and even up to collaboration during audits and inspections. Qualification & Validation VTU provides GMP services for the qualification and validation as well as for the introduction of GMP-compliant processes in development, production, technology, the control laboratory, and in the storage and transport area. Establishment of customised risk management Validation of analytical methods GMP-compliant documentation, data generation, storage and archiving Preparation and revision of relevant SOPs (for methods and procedures) Establishment of OOS/OOE procedures Creation and moderation of risk analyses Development of customised change and/or deviation management / CAPA systems Development of customised GMP qualification strategies Preparation and support for audits, execution of supplier audits Preparation of master plans Storage and transport validation Qualification (DQ, IQ, OQ, PQ) for systems, media, rooms and lab equipment Establishment of measures for plant hygiene Process, cleaning, and computer validation Conducting GMP-relevant training

4 QM Systems for Pharmaceuticals and Medical Devices Make use of our competence. Our experts are trained engineers, chemists, biotechnologists and have years of experience with quality management systems in accordance with EN ISO 13485:2003 and cgmp. We will advise you in the setup of your QM systems and prepare the documentation for you that is necessary for your quality management system. Our trained auditors will conduct internal audits for you as well as supplier audits. We prepare you for external audits and will accompany you during those audits. Setup of QM system according to GMP for pharmaceuticals and ISO for medical products QM manual and customised SOP systems Documentation and documentation checks Measures for measurement, analysis and improvement Management of resources Requirements of development and product realisation Qualification and validation systems Risk management Measures for plant hygiene Conducting GMP training Change management and CAPA OOS/OOE systems Supplier audits Preparation for official/customer audits Execution and support for self-inspections Accompaniment for official inspections

5 VTU is a competent partner for all GMPrelevant areas. We have the best knowledge of the rules and will coordinate your activities to achieve GMP conformity taking into consideration the national requirements and including the latest developments: quality by design as per ICH Q8 risk management as per ICH Q9 and EN ISO 14971:2009 quality management systems & product lifecycle as per ICH Q10 or EN ISO 13485:2010 upcoming ICH Q11 Development and Manufacture of Drug Substances FDA Guidance for Industry Process Validation: General Principles and Practices (2011) EMEA Guideline on process validation We define customised solutions for your systems/organisation that are based on risk analysis and span the entire development, planning, production and validation lifecycle. Company Portrait VTU Engineering is engineer and supplier for the pharmaceutical, life science and medical devices. We focus on GMP Services as part of qualification and validation of plants, processes, computer systems and medical devices. VTU offers GMP services as part of the qualification and validation of plants, computer systems and processes and medical devices. Furthermore we offer consulting for the introduction of GMP compliant processes in engineering, production, laboratories and quality assurance and even up to collaboration during audits and inspections. Our engineers all draw on their extensive experience to plan a wide array of projects. Through our work and constant further education in the field of pharmaceutical engineering and GMP requirements, our experts are intimately familiar with the necessities of the industry. You too can benefit from our high level of technical competence and know-how in project management. VTU Engineering s sustained success since it was established in 1990 rests on two pillars. High qualified engineers In addition to their technical know-how, VTU engineers excel through high capability for teamwork in many different project environments. Permanent training and a proven knowledge management system are a guarantee that our customers receive best expertise. Customer orientation The objective of the project is the objective of our work. Achieving our customers goals and providing solutions of excellent quality and benefit are top priorities of our project teams. Consequently, a very high percentage of our customers cooperate with VTU since many years

6 Pharmaceuticals & Biotechnology GMP Compliance AUSTRIA HEADQUARTERS: A-8074 Grambach/Graz Parkring 18 Tel.: +43 (316) GERMANY HEADQUARTERS: D Hattersheim Philipp-Reis-Straße 2 Tel.: +49 (6190) ITALY HEADQUARTERS: VTU Engineering Italia Srl I Bozen Pfarrhofstraße 2d Tel.: +39 (0471) BRANCH OFFICES: A-1110 Vienna Office Campus Gasometer Guglgasse 15/4b Tel.: +43 (1) BRANCH OFFICES: D Rheinbach bei Bonn Marie-Curie-Straße 1 Tel.: +49 (2226) BRANCH OFFICE: VTU Engineering Italia Srl I Mirano (VE) Via Miranese 98/C Tel.: +39 (041) D Penzberg Im Thal 1 Tel.: +49 (8856) VTU Engineering Italia Srl I Cinisello Balsamo Milano Via Margherita Viganò De Vizzi, 93/95 A-4020 Linz St. Peter-Straße 25 Tel.: +43 (732) A-6250 Kundl Ing.-Hermann-Lindner-Str. 9 Tel.: +43 (5338) office@vtu.com D Braunschweig Bültenweg 73 Tel.: +49 (531) SWITZERLAND VTU Engineering Schweiz AG CH-4125 Riehen bei Basel Rüchligweg 101 Tel.: +41 (61) D Burghausen Marktler Strasse 63 VTU Engineering Schweiz AG CH-6312 Steinhausen/Zug Industriestrasse 51 VTU Engineering Schweiz AG CH-1870 Monthey Avenue de la Gare 15 ROMANIA - Sucursala Bucuresti Str. Virgil Madgearu 16-18, District 1 Bucharest, Romania Tel.: +40 (735) VTU_GMP_fo_13v1_en