GMP Compliance

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GMP ComplianceGMP Compliance

Systems, processes, personnel and documen-tation 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 unavo-idable 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:

Everything you need for GMP Compliance!

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 parame-ters (cQA, cPP), the establishment of a design space as well as its verification by means of, for example, DoE Methodology & Experi-ments, 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 imple-mentation of customised QbD approaches facilitates an increased product and process understanding as well as an efficiency incre-ase during production. VTU provides support in QbD-based development processes and their implementation in new manufacturing processes or alterna-tively their integration in existing GMP-compliant manufacturing processes:

Pharmaceutical Development, Quality by Design (QbD)

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 Experi-ments (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 docu-ments)

Preparation and revision of SOPs

Pharmaceuticals industry Biotechnology Medical devices Storage and transport Active ingredient production Quality control labs / R&D labs Hospitals / institute pharmacies Blood and tissue banks

VTU offers GMP services as part of the qualification and validation of plants, computer systems and processes in the pharmaceuticals industry and in medi-cal technology, consulting for the intro-duction of GMP compliant processes in engineering, production, laboratories and quality assurance and even up to colla-boration during audits and inspections.

VTU provides GMP services for the qualification and validation as well as for the introduction of GMP-compliant processes in development, pro-duction, technology, the control laboratory, and in the storage and transport area.

Qualification & Validation

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

Development of customised change and/or deviation management / CAPA systems

Preparation and support for audits, execution of supplier audits

Storage and transport validation

Establishment of measures for plant hygiene

Conducting GMP-relevant training

Establishment of customised risk management

Creation and moderation of risk analyses

Development of customised GMP qualification strategies

Preparation of master plans

Qualification (DQ, IQ, OQ, PQ) for systems, media, rooms and lab equipment

Process, cleaning, and computer validation

VTU offers GMP services as part of the qualification and validation of plants, computer systems and processes in the pharmaceuticals industry and in medi-cal technology, consulting for the intro-duction of GMP compliant processes in engineering, production, laboratories and quality assurance and even up to colla-boration during audits and inspections.

VTU offers GMP services as part of the qualification and validation of plants, computer systems and processes in the pharmaceuticals industry and in medi-cal technology, consulting for the intro-duction of GMP compliant processes in engineering, production, laboratories and quality assurance and even up to colla-boration during audits and inspections.

Make use of our competence. Our experts are trained engineers, chemists, biotechnolo-gists 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.

QM Systems for Pharmaceuticals and Medical Devices

Setup of QM system according to GMP for pharmaceuticals and ISO 13485 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

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 neces-sities 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

VTU is a competent partner for all GMP-relevant areas. We have the best knowledge of the rules and will coordinate your activi-ties 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.

Pharmaceuticals & Biotechnology

GMP Compliance

office@vtu.com

www.vtu.com

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VTU_GMP_fo_13v1_en

AUSTRIAHEADQUARTERS:VTU Engineering GmbHA-8074 Grambach/GrazParkring 18Tel.: +43 (316) 4009-200

BRANCH OFFICES:VTU Engineering GmbHA-1110 ViennaOffice Campus GasometerGuglgasse 15/4bTel.: +43 (1) 29 888 29-100

VTU Engineering GmbHA-4020 LinzSt. Peter-Straße 25Tel.: +43 (732) 776422-0

VTU Engineering GmbHA-6250 Kundl Ing.-Hermann-Lindner-Str. 9Tel.: +43 (5338) 20690

GERMANYHEADQUARTERS:VTU Engineering Deutschland GmbHD-65795 HattersheimPhilipp-Reis-Straße 2Tel.: +49 (6190) 93 624 0

BRANCH OFFICES:VTU Engineering Deutschland GmbHD-53359 Rheinbach bei BonnMarie-Curie-Straße 1Tel.: +49 (2226) 8721-00

VTU Engineering Deutschland GmbHD-82377 PenzbergIm Thal 1Tel.: +49 (8856) 9362-529

VTU Engineering Deutschland GmbHD-38106 BraunschweigBültenweg 73Tel.: +49 (531) 288 535-70

VTU Engineering Deutschland GmbHD-84489 BurghausenMarktler Strasse 63

ITALYHEADQUARTERS:VTU Engineering Italia SrlI-39100 BozenPfarrhofstraße 2dTel.: +39 (0471) 402-405

BRANCH OFFICE:VTU Engineering Italia SrlI-30035 Mirano (VE)Via Miranese 98/CTel.: +39 (041) 838 00 03

VTU Engineering Italia SrlI-20092 Cinisello Balsamo – MilanoVia Margherita Viganò De Vizzi, 93/95

SWITZERLANDVTU Engineering Schweiz AGCH-4125 Riehen bei BaselRüchligweg 101Tel.: +41 (61) 601 29-83

VTU Engineering Schweiz AGCH-6312 Steinhausen/Zug Industriestrasse 51

VTU Engineering Schweiz AGCH-1870 MontheyAvenue de la Gare 15

ROMANIAVTU Engineering GmbH - Sucursala BucurestiStr. Virgil Madgearu 16-18, District 1Bucharest, RomaniaTel.: +40 (735) 537 976