Raumedic certified according to the current ISO quality standard for primary packaging materials for pharmaceuticals

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As a manufacturer of packaging solutions for the pharmaceutical industry, Raumedic is subject to special regulatory requirements. The fact that the plastic processing company complies with these regulations has now been proven once again. Dr. Winfried Bernhard, Head of Quality Management at Raumedic, was able to personally receive the corresponding proof on February 15th. Jutta Deinbeck from Bavaria Certification handed him the accredited certificate for the current ISO standard 15378:2016-3. This was preceded by a three-day recertification audit, during which the Bavarian certification body itself was accredited.

For producers of primary pharmaceutical packaging, ISO standard 15378 specifies the requirements for the internal quality management system. Because, in addition to the active ingredient and formulation, the packaging of a drug also influences its effectiveness. Since so-called primary packaging materials come into direct contact with the medication, special care must be taken during their production. "Controlled processes and production in a cleanroom help us to minimize contamination risks," explains the Raumedic QM manager. This enables the company to offer its customers optimal polymer packaging.

In general, the regulatory framework combines industry-specific principles of Good Manufacturing Practice (GMP) with a variety of legal requirements. The standard incorporates requirements from the Medicinal Products Act, the Medicinal Products and Active Substance Manufacturing Regulation, and the US Food and Drug Administration (FDA) for pharmaceutical manufacturers.