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Pilot Plant 2
Pilot Plant 2

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HAPILA gains DIN ISO certification

HAPILA GmbH has passed a further significant milestone to ensure a high quality level for their offered services and products. The TÜV Thüringen e.V. (Technical Supervision Association Thuringia) has granted a DIN ISO certification for the installed Integrated Management System. This allows us to be qualified as meeting the standards DIN EN ISO 9001:2015 for Quality management systems (QMS), as well as DIN EN ISO 14001:2015 Environmental management systems (EMS) and DIN ISO 45001:2018 Occupational Health & Safety (OHS) management systems.

The DIN ISO certification covers HAPILA’s GMP compliant development, manufacturing and distribution of active pharmaceutical ingredients (APIs) as well as reference substances and API for In-vitro- diagnostic products, medical products and/or clinical samples.

The certification audit focused on the main ISO quality management principles: customer focus, leadership, human engagement, process approach, improvement, evidence-based decision making and relationships management. HAPILA passed with no deviations. Further annual surveillance audits will verify continued effectiveness and adequacy of installed procedures and systems.

With this new certification, we are now able to combine the GMP requirements of the EU Guideline of Good Manufacturing Practice, Part II for API manufacturing, verification and release with the requirements of the international management system standards ISO 9001, 14001 and 45001 in one Integrated Management System that can control all processes within the company. In this way we can meet the needs of customers who may not require cGMP manufacturing but definitely demand high levels of assured quality, especially when it comes to reference substances and APIs for In-vitro- diagnostic products.

HAPILA’s strategy is to work for continuous improvement of its management systems to ensure high process reliability under compliance with legal and regulatory requirements, as well as furthering employee development and training together with the highest health, safety and environmental (HSE) standards. All of these are vital for customer confidence.