Pharmaceutical secondary packaging: Precision, GMP, and flexibility from Austria

Why secondary packaging is so crucial.

Pharmaceutical secondary packaging is far more than just a matter of packaging. It is the final stage of manufacturing before delivery and is therefore crucial for pharmaceutical product safety, compliance, and supply sovereignty. In an industry shaped by regulatory requirements, global supply chains, and clinical trials, the quality and flexibility of secondary packaging determine speed, safety, and market success. Secondary packaging solutions cover a wide range of options, all specifically tailored to the needs of the pharmaceutical industry.

Complex Pharmaceuticals, located near Vienna, specialises in this area. With a 7,800m² high-end facility, GMP-certified processes and modular production structures, the company offers tailor-made solutions – for biotech-startups as well as for international pharmaceutical corporations. Examples of secondary packaging in the pharmaceutical industry include blister packs and folding cartons, which are used to package pharmaceutical products safely and in compliance with regulations.

What is meant by pharmaceutical secondary packaging?

Per definition, secondary packaging refers to all packaging steps that take place after the primary packaging (meaning the immediate container of the pharmaceutical product, such as vials, blisters, or ampoules). It is a central component of the pharmaceutical process and provides solutions to the industry’s diverse requirements. Key aspects of secondary packaging include protection, traceability, compliance, and meeting regulatory standards. Adherence to Good Manufacturing Practice (GMP) and fulfilment of GMP requirements are essential, as is compliance with all relevant industry rules and guidelines. Services offered in the field of secondary packaging include, among others:

  • Cartoning and assembly of pharmaceutical products
  • Labelling with batch numbers and expiry dates
  • Patient information leaflets in multiple languages
  • Serialisation and aggregation in accordance with EU guidelines
  • Special requirements such as warning labels or safety features
  • Use of cartons as a sustainable, eco-friendly packaging option

Inspection of packaging is an essential part of quality assurance and ensures compliance with all regulatory requirements. The entire secondary packaging process is a key element of the pharmaceutical value chain and makes a significant contribution to product safety and successful market launch.

GMP standards as a foundation of trust

What does GMP-complaint mean?

“GMP“ stands for Good Manufacturing Practice. This internationally recognised standard ensures that all processes in pharmaceutical production and packaging are transparent, safe, and conducted to the highest quality standards. The granting of a GMP certificate officially confirms compliance with GMP requirements and serves as a crucial demonstration of quality assurance for the industry. A GMP certificate is awarded after a successful inspection by regulatory authorities or independent bodies and is of great importance for companies in the pharmaceutical, food, and medical technology industries.

Compliance with GMP requirements and good manufacturing practice forms the foundation for quality assurance and product safety. Rules, guidelines, and regular inspection of production processes play a central role throughout the entire GMP process. Various aspects, such as production, environmental conditions, and staff qualifications, are taken into account to ensure the breadth and complexity of GMP compliance. Adhering to these standards has a decisive impact on product quality, consumer health, and market success in the industry. Our extensive experience with GMP certification enables us to manage the entire process efficiently and to present the associated costs transparently.

In the context of secondary packaging, this means specifically:

  • Complete documentation of every packaging step
  • Traceability down to the individual pack
  • Auditable processes for contract manufacturing clients
  • Consistent quality regardless of batch size

Complex Pharmaceuticals operates in strict accordance with GMP standards providing maximum quality for its partners

Quality assurance and control: Safety at the highest level

In the pharmaceutical industry, quality assurance is a central element in ensuring the safety and effectiveness of pharmaceutical products and other products. Every step – from the selection of materials and active ingredients through manufacturing, to packaging and distribution – is subject to strict GMP guidelines and clearly defined quality standards. Only in this way can it be ensured that every product meets the high standards of the industry and that patient health is optimally protected.

A key element of quality assurance is the consistent monitoring across the entire supply chain.
Throughout the entire manufacturing process, standardised procedures and documented processes ensure that compliance with all relevant requirements remains fully traceable at all times.

Regular GMP audits – both internal and external – are an indispensable tool for verifying adherence to current guidelines and enabling continuous improvements. These audits help to identify potential weaknesses early and address them proactively before they could affect product quality or safety.

Another key factor is the qualification and ongoing training of employees. Only with comprehensive knowledge of applicable regulations, processes, and technologies can they maintain the high quality standards in their daily work and make a decisive contribution to quality assurance.

The packaging itself plays a central role in quality assurance. It not only protects the product during transport and storage, but also carries important information – for example, on ingredients, usage, or warnings – supporting the safe use of the product by patients. Modern packaging solutions, such as smart packaging with integrated sensors or RFID technology, offer additional opportunities to monitor and control product quality throughout the entire supply chain.

For companies in the pharmaceutical industry, consistent quality assurance and control are not only a legal requirement but also a critical safety factor. They build trust with customers and partners, ensure compliance with all relevant requirements, and contribute significantly to the company’s long-term success.

Technologies and capacities at Complex Pharmaceuticals

The modern facility near Vienna combines efficiency, flexibility and compliance

  • 7,800 m² high-end packaging facility
  • Processing from 1 to 1,000,000 packs – the high volume of packs handled highlights our flexibility and performance in the market.
  • Modular production lines for rapid switches between vials, ampoules, blisters or bottles
  • Serialisation and aggregation in accordance with EU GMP
  • Sustainable packaging solutions wherever possible
  • Cartons as an environmentally friendly and sustainable packaging option, providing a resource-saving alternative to plastic

We offer the possibility to tailor secondary packaging services to your individual requirements. Our solutions include GMP-compliant services, innovative packaging concepts, and the development of customised services for the pharmaceutical industry.

Our focus is on creating innovative packaging solutions and moving away from plastic to meet environmental requirements.

Efficient processes ensure rapid and seamless execution, providing cost advantages for our customers and strengthening their market position.

Our extensive experience in developing and implementing packaging solutions for the pharmaceutical industry guarantees the highest levels of quality and reliability.

Speed and flexibility as a competitive edge

In clinical trials and during market launches, every hour counts. Complex Pharmaceuticals specialises in delivering maximum flexibility, even under tight timelines, and offers tailored solutions and services to meet a wide range of requirements. Our comprehensive secondary packaging services support rapid market entry and help ensure the commercial success of new products. Efficient processes enable short turnaround times and deliver clear cost advantages for our customers:

  • Flexible format changes reduce downtime
  • Well-established processes enable rapid turnaround times while maintaining the highest quality

For companies, this means: predictable planning and a competitive edge – without compromising compliance or safety. 

Location advantage: Vienna

In recent years, Austria has developed into a strong hub for the pharmaceutical and biotech industries. Complex Pharmaceuticals’ location near Vienna provides clear advantages for the pharmaceutical sector and positions the company as a key player in the European pharmaceutical services market.

  • Central location in Europe with connections to Germany, the Czech Republic, Hungary, and Slovakia
  • Legal certainty and regulatory stability • High quality standards through strict national and EU regulations
  • Access to highly qualified professionals in Vienna’s life sciences cluster

Our extensive experience and expertise in pharmaceutical services enable innovative solutions and the highest quality throughout the entire process.

International clients always have the possibility to get in touch with us directly to explore customised solutions and services.

This makes Austria an ideal partner for ensuring Europe’s pharmaceutical supply sovereignty.

Sustainability in pharmaceutical packaging

In addition to safety and speed, sustainability is becoming increasingly important. Complex Pharmaceuticals therefore focuses on:

  • Sustainable packaging materials such as cartons and other environmentally friendly materials, offering resource-efficient and biodegradable solutions, where permitted by regulatory requirements
  • The transition from plastic to sustainable packaging solutions
  • Energy-efficient processes in the packaging line
  • Photovoltaic systems to cover part of the energy demand
  • Optimised logistics processes to reduce transport routes and emissions

Sustainable development is of central importance for the entire industry to drive innovation and meet international requirements. In this way, the company combines pharmaceutical excellence with environmental responsibility.

Conclusion: Packaging with responsibility

Nowadays, secondary packaging is a key factor for pharmaceutical product safety, marketability, and supply sovereignty. It has a significant impact on product quality, the launch of new products, and compliance with regulatory requirements in the pharmaceutical industry. With state-of-the-art capacities, GMP-certified processes, and a strong focus on flexibility, Complex Pharmaceuticals offers comprehensive solutions and services for the pharmaceutical industry in Austria, including customised packaging services, logistics services, and quality controls.

Our extensive experience and expertise in the development and market launch of innovative packaging solutions ensure the highest standards and reliability. We consider all relevant aspects of production, environmental impact, and staff qualifications to meet the demands of the market.

Get in touch with us to take your pharmaceutical packaging to the next level. We are happy to assist you with any questions or requests regarding our services.

Questions and answers

Pharmaceutical secondary packaging

Primary packaging (PP) includes all materials that come into direct contact with the product (liquid, tablet, etc.), while secondary packaging refers to everything that surrounds the primary packaging to ensure compliance with legal, regulatory, and quality management requirements.

GMP stands for Good Manufacturing Practice. It refers to mandatory rules and guidelines (e.g., EU-GMP, US-cGMP) designed to ensure that the manufacturing and packaging of products – especially pharmaceutical products and active ingredients – are carried out consistently according to high-quality standards. GMP is central to regulated industries such as pharmaceuticals, while in the food sector, complementary systems like HACCP apply.

A GMP certificate is an official confirmation, stating that a company complies with GMP guidelines. The GMP certification is carried out through a national authority. It serves as an important proof of quality assurance and market access in the pharmaceutical industry.

GMP requirements (Good Manufacturing Practice) regulate key aspects such as quality assurance, hygiene, documentation, and traceability at all stages of production, including the packaging process. They are set out as mandatory in national and international guidelines and regulations.

Für die Sekundärverpackung gelten zahlreiche Regeln und Richtlinien, darunter insbesondere der EU-GMP-Leitfaden sowie weitere behördliche Vorgaben. Ihre Einhaltung ist unerlässlich, um Produktsicherheit, Rückverfolgbarkeit und regulatorische Konformität sicherzustellen – und damit die Voraussetzung für eine erfolgreiche Markteinführung.

Inspection includes the control of all packaging steps, the analysis of materials and the monitoring of compliance with GMP standards. It is a central component of quality assurance and has a significant impact on the safety and effectiveness of the product.

Secondary packaging includes key aspects such as product protection, sustainability, qualified staff and efficient processes. It significantly influences the quality, safety, and marketability of pharmaceutical – and, in part, food-related – products

Complex Pharmaceuticals offers comprehensive services and solutions in the area of GMP-compliant secondary packaging, including labelling, repackaging, management of secondary packaging materials and customised packaging solutions.

Sustainable solutions include cartons made from paper fibres and biodegradable, resource-efficient materials as alternatives to plastic. This shift towards greater sustainability is a key focus in the development of the packaging industry.

The costs for contract manufacturing vary depending on the scope and individual requirements. Complex Pharmaceuticals processes between 1 and 1,000,000 packs in GMP compliance – flexibly for both clinical trials and large-scale production runs.

It is possible to develop customised solutions and implement innovative packaging technologies to meet the specific requirements of customers and the market.

Secondary packaging plays a significant role in the launch of new pharmaceutical products and influences market positioning. Its development and adaptation to market demands are crucial for market success.

Complex Pharmaceuticals processes between 1 and 1,000,000 packs in full GMP compliance – offering flexibility for both clinical trials and large-scale production runs.

Clinical trial materials can be packaged and delivered within 48 hours of approval.

Thanks to its central location, high regulatory standards and legal certainty, companies benefit from rapid, stable and reliable processes.