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Primary packaging for the pharmaceutical industry: between efficiency pressure and quality requirements!

Quality Assurance and Quality Control Concept - Modern graphic interface showing certified standard process, product warranty and quality improvement technology for satisfaction of customer.
Jan 24, 2024
8 minutes read

Primary packaging is a decisive factor for the safety of medicines. Despite their fundamental importance, they are still often underestimated. This is where ISO 15378:2017 comes in, combining the process-oriented approach of ISO 9001:2015 - with specific requirements (GMP principles) of the pharmaceutical packaging industry. This combination forms a robust protection system against contamination risks and quality defects. Compliance with ISO 15378 has become essential for primary packaging manufacturers, especially since the revision of GMP Annex I on the "Manufacture of sterile medicinal products" in August 2022, which requires higher production standards. The first article in our series "Primary packaging in focus: Increasing requirements and new opportunities!" explains how ISO 15378 defines the standards for primary packaging and why its implementation is so important. You will learn how the standard helps to meet regulatory requirements, increase product quality and strengthen customer confidence.

In addition to clinical efficacy, quality and safety are top priorities in the pharmaceutical industry. At the heart of these efforts is the primary packaging of medicines, which is crucial for protecting medicines from external influences. Their importance arises from the direct contact with the medicines, which means that they are subject to strict regulatory and legal requirements.

A clear distinction between standard primary packaging and medical devices that also serve as packaging is essential for fulfilling these requirements. While the primary function of primary packaging is the preservation and safety of the medicinal product, medical device components must also meet the specific criteria of the Medical Device Regulation (MDR), particularly with regard to safety and performance.

This differentiation is fundamental for the entire process chain in the development, manufacture and approval of medicinal products. In this context, the observance and implementation of quality standards such as Good Manufacturing Practice (GMP) and ISO 15378 is essential for pharmaceutical manufacturers. They ensure that the packaging meets the highest safety and quality requirements, thereby safeguarding the integrity and efficacy of the medicines.

Challenges and regulatory aspects: GMP and ISO 15378 as quality standards!

Although good manufacturing practices (GMP) are not legally required for manufacturers of primary packaging in the pharmaceutical industry, they play a central role in quality assurance. They ensure the systematic control and manufacture of products, which is essential due to the direct contact of primary packaging with medicinal products. Often GMP requirements are defined by customer contracts, which encourages manufacturers to take a reactive approach. However, a proactive application of GMP standards promotes continuous quality improvement and prevents quality issues.

To address these challenges and further optimize compliance with quality standards, ISO 15378 comes into play.

This standard, developed specifically for standard primary packaging materials, differs significantly from packaging materials that are considered medical devices. It integrates GMP principles into a comprehensive quality management system and focuses on ensuring product quality, minimizing contamination risks and optimizing production processes.

Under the magnifying glass: ISO 15378 and important GMP requirements for primary packaging manufacturers!

ISO 15378:2017 builds on the process-oriented ISO 9001:2015 and fully integrates it. It supplements ISO 9001 with specific "Good Manufacturing Practice (GMP)" requirements, which are assigned to the individual chapters at relevant points. This makes it easier for primary packaging manufacturers to implement GMP by providing clear guidance. The focus is on customer satisfaction and efficient process orientation, with the standard referring in particular to the PDCA cycle (Plan-Do-Check-Act) and risk-based thinking. The latter is particularly emphasized in Annex A of ISO 15378, as it is an effective tool for analyzing processes and increasing efficiency. It makes it possible to identify significant risks and increase product quality while creating room for agility.

ISO 15378:2017 specifically addresses the needs of primary packaging manufacturers in the pharmaceutical industry by, among other things

  • clear definition of quality and customer satisfaction: Chapter 4.4 emphasizes the need to implement and monitor quality objectives in order to ensure product quality and customer satisfaction.
  • structured documentation of changes: Chapter 6.3 expands ISO 9001 to include detailed requirements for change control processes, which includes careful documentation, evaluation and implementation of changes.
  • improved traceability: Chapter 8.5.2 of ISO 15378 reinforces the general traceability requirements of ISO 9001:2015 with specific GMP requirements. This enables detailed documentation of all manufacturing steps and the implementation of an effective system for tracing production materials.
  • higher requirements for production hygiene: ISO 15378 supplements chapters 8.5 and 8.5.4 of ISO 9001 with precise GMP requirements for product purity and contamination control during production and storage
  • specific guidelines for process validation: The standard provides guidelines for the validation of production processes in the relevant chapters and contains detailed guidelines for the design of adequate validation procedures in Annex D.

In short, ISO 15378:2017 provides a comprehensive framework for primary packaging manufacturers in the pharmaceutical industry to effectively meet and continuously improve the highest quality standards.

ISO 15378 as a key standard for primary packaging manufacturers in the pharmaceutical industry!

As outlined, ISO 15378:2017 is an essential tool for primary packaging manufacturers in the pharmaceutical industry. This standard combines ISO 9001:2015 with specific GMP principles, creating a robust standard for quality and safety. It promotes compliance with regulatory requirements, increases product quality and strengthens customer confidence. With its focus on improved production processes, clear traceability and increased hygiene standards, it makes a decisive contribution to ensuring the integrity and efficacy of medicinal products.

As experts in quality management systems and GMP requirements, our experts at TentaConsult Pharma&Med GmbH offer targeted support for certification processes, process optimization and product design.

Specializing in the ISO 15378 standard, we combine process-oriented approaches with GMP standards to efficiently meet our customers' requirements and optimally integrate quality management systems into company processes.

We guide companies through the entire process - from requirements analysis to distribution - and ensure efficient and effective solutions that are tailored to individual needs.

With TentaConsult, you can achieve the highest quality standards and strengthen your market position.

Contact us to benefit from our expertise.

Do you require help or further information?
Contact us! We are happy to advise you:
Elena Kortemeyer
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