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Pharmaceuticals: Quality, Compliance, and Safety Throughout the Entire Value Chain

The pharmaceutical industry faces increasing regulatory requirements, complex supply chains, and rising quality standards. TÜV NORD supports companies with testing, certification, audits, qualification, and independent assessments throughout the entire product life cycle.

Our services for the pharmaceutical industry
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Future-Proof Solutions for the Pharmaceutical Industry

The development, manufacture and supply of medicinal products require the highest standards of quality, safety and compliance. At the same time, digitalisation, sustainability, supply chain requirements and international regulations are reshaping the industry’s operating environment. TÜV NORD supports pharmaceutical companies as an independent partner, offering a wide range of services.

Challenges in Pharmacy

Ensuring compliance with regulatory requirements: international regulations, increasing documentation requirements and regular audits call for robust management systems and traceable processes.

Making pharmaceutical supply chains resilient: Global supply chains place greater demands on transparency, quality assurance and risk management.

Implementing digitalisation securely: From manufacturing execution systems to laboratory information systems, the demands on information security and cyber security are growing.

Sustainability in the pharmaceutical industry: Companies face the challenge of reducing emissions and implementing regulatory sustainability requirements.

ISO 15378 Zertifizierung - Medikamentenverpackungen ohne Beschriftung als Blisterpackungen und als Kunststoffbehälter

Quality Management and GMP Requirements

An effective management system builds trust with regulatory authorities, business partners and patients.

ISO 15378 – Primary packaging for medicinal products, GMP compliance

Audit and certification of document management systems

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The Benefits of Working with TÜV NORD

  • Independent testing and certification partner
  • International expertise
  • Cross-sector expertise
  • Extensive experience in regulated industries
  • Comprehensive solutions from a single source

Frequently Asked Questions from the Pharmaceutical Industry

Depending on the field of activity, standards such as ISO 15378, ISO/IEC 27001, ISO 13485 and other sector-specific requirements may be relevant.

Through management systems, technical security measures, audits and certifications such as ISO/IEC 27001 or IEC 62443.

Sustainability requirements are becoming increasingly important and relate, amongst other things, to energy efficiency, emissions management and supply chains.

TÜV NORD supports businesses by providing inspections, audits, certification, assessments and training programmes to help them meet technical, organisational and regulatory requirements.

All services for the pharmaceutical industry

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Certification of data centers according to TSI, EN 50600, or ISO/IEC 22237
The certification of data centers according to TSI, EN 50600, or ISO/IEC 22237 by TÜV NORD guarantees availability, security, and resilience. Since 2002, over 1,000 projects have been successfully completed, making certified data centers a reliable benchmark in Germany and internationally and creating trust among third-party users.
Certification of security requirements in accordance with IEC 62443-2-1 and -2-4
The IEC 62443 standard provides an internationally recognized standard for network security in the process and automation industry, which is increasingly used in Industry 4.0. It helps prevent cyberattacks and serves as proof of due diligence in accordance with the Industrial Safety Regulation and Product Safety Act.
Certification of technical control centers according to TSA.STANDARD
The certification of alarm receiving centers and technical control centers in accordance with TSA.STANDARD or EN 50518 by TÜV NORD guarantees maximum reliability. It provides objective proof of the effective implementation of technical, operational, and organizational requirements, including process control and plant monitoring centers, for precise control and monitoring.
Commissioning of data centers
TÜV NORD's commissioning of data centers includes integration tests that ensure the proper functioning of critical infrastructure such as power supply, climate control, and security systems. As a neutral third party, TÜV NORD provides quality assurance to ensure trouble-free operation and verify system interactions.
Conformity assessment and GAP analysis of alarm receiving centers and technical control centers
TÜV NORD's conformity assessment and GAP analysis of alarm receiving centers and technical control centers identifies risks and potential for improvement. It provides a snapshot of the current level of security and optimally prepares you for certification according to EN 50518 or TSA.STANDARD.
Conformity assessment of data centers
TÜV NORD's conformity assessment of data centers ensures physical security and availability through standards such as TSI, EN 50600, and ISO/IEC 22237. These provide comprehensive requirements definitions for power supply, climate control, building construction, and security systems, enabling companies to demand quality guarantees from colocation providers.
TSA.STANDARD: Physical protection of alarm receiving centers/technical control centers
The TSA.STANDARD from TÜV NORD is a comprehensive catalog of criteria for the certification of alarm receiving centers and technical control centers, based on DIN EN 50518. It ensures physical security and reliability, supplemented by additional features for functional safety.
TSE.STANDARD: Energy efficiency & sustainability in data centers
The TSE.STANDARD from TÜV NORD supports data centers in implementing energy efficiency and sustainability in accordance with the Climate Neutral Data Center Pact and the Energy Efficiency Act. It offers a modular system for compliance with EU directives and ISO 50001:2018 to demonstrate CO2 neutrality and sustainable operation.
TSI.INTENSIVE Trainings
The TSI.INTENSIVE training courses offered by TÜV NORD provide an in-depth examination of topics such as refrigeration, energy supply, fire alarm and extinguishing technology, safety systems, and EN 50600 & ISO 22237. These one-day modules complement the TSI.PROFESSIONAL training and can also be booked separately to develop practical supply concepts.
TSI.PROFESSIONAL Training
The TSI.PROFESSIONAL training course from TÜV NORD offers comprehensive insights into the planning, construction, and operation of data centers, based on the TSI methodology and the TSI.STANDARD. It covers physical security, availability, and energy efficiency, based on BSI IT-Grundschutz and standards such as DIN EN 50600.
TSI.PROFESSIONAL Update Training
The TSI.PROFESSIONAL update training course from TÜV NORD extends your TSI.PROFESSIONAL status by 24 months. It includes individually planned content, including changes to TSI.STANDARD and TSI.EN50600, current standards, new processes, group exercises, and experience sharing.
TSI.STANDARD: Availability & Physical Protection of Data Centers
TSI.STANDARD is a methodology developed by TÜV NORD for evaluating and certifying the physical security and availability of data centers. It offers a holistic approach that takes into account the physical infrastructure, organizational processes, and documentation to ensure high availability and security of the infrastructure.

Training and Continuing Education

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