The EMA’s current Q&A on handling Out-Of-Specification (OOS) batches in Advanced Therapy Medicinal Products highlights the stringent requirements for documentation and traceability in this field.
If an OOS result occurs, the manufacturer is initially responsible. It is the manufacturer’s responsibility to analyse the root causes and document the resulting risk analysis. At the same time, reporting obligations to treating physicians and the relevant authorities apply. Moreover, the EMA requires regular OOS batch overviews to track and assess developments in the manufacturing process.
The situation becomes more complex when multiple organisations are involved. In cases involving multiple parties, such as the manufacturer, importer, and marketing authorisation holder, responsibilities must be clearly defined and set out in contractual agreements. At the same time, the regulatory framework requires complete documentation of all relevant production and quality data. This includes information about the product’s manufacturing, testing, transportation, and storage.
Taken together, these requirements highlight the need for digital quality processes. Three aspects are particularly relevant: First, supplier qualification whenever multiple organisations are involved in production or distribution. Second, comprehensive document control covering risk analyses, agreements, and regulatory documentation. Third, audit-compliant archiving to ensure long-term traceability of all batch-related information.
A capable QMS system is designed to address exactly these requirements. It creates the structural and technical basis for systematically addressing regulatory requirements and maintaining full traceability over time.
With our solution, we support companies in digitalising precisely these processes. This includes not only the software itself, but also its structured implementation and integration into existing quality processes. The goal is to create a standardised, validated process that fulfills regulatory requirements while improving operational efficiency.
