Global Closure Systems obtains ISO 15378

Global Closure Systems (GCS) extends its portfolio of quality certifications with the attainment of ISO 15378 by Astra Plastique, one of its plants in France, and demonstrates its manufacturer’s capability to meet requirements of the Healthcare sector. GCS manufacturing 1.5 billion closures annually and offering one of the world’s leading ranges of Child Resistant Closures (CRC), Tamper Evident closures, droppers and dosing devices for the pharmaceutical market.

Obtaining this Standard confirms its ability to provide primary packaging materials for medicinal products that consistently meet customer requirements. ISO 15378:2011 certification also specifies the conditions for complying with International Standards applicable to primary packaging materials and Good Manufacturing Practice (GMP) guidelines for pharmaceutical product manufacturing.

"This new accreditation is an important step for GCS as it confirms our rigorous implementation of GMPs. It ratifies Astra Plastique’s commitment to performance and rewards the dedication of its team to achieving the highest quality", said Vincent Clauzel, Vice President of GCS France.

"Astra Plastique entered the Healthcare sector over 35 years ago and has a long track record of providing capping solutions to this sector," added Mr Clauzel.
Astra Plastique is already certified according to ISO 9001 (Quality Management), OHSAS 18001 (Occupational Health and Safety Management) and Directive 93/42/EEC (European Council Directive concerning medical devices). The facility, which recently opened a state-of-the-art ISO 7 cleanroom – in order to reinforce its ability to provide the highest quality standards and increase its capacity of production – has also renewed its ISO 22000/PAS 223 certification (Food Safety Management).

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