Quality at Nelipak

Nelipak Healthcare Packaging is a quality driven organisation committed to supplying products and services to the medical device and pharmaceutical industries that meets or exceeds customers’ requirements.

At all levels of the organization, we are dedicated to continuously improving our procedures and processes. Our staff play are an integral part of monitoring and improvement of the quality process. We employ GMP in our production operations for medical and pharmaceutical products.

Additionally, we have full product traceability – raw materials, auxiliary materials, inspection results, production conditions and employees involved can be traced for all our products.

All Nelipak facilities where products are made, are certified to ISO 13485 for the design and manufacture of custom thermoformed plastic packaging and products to customer specifications. Our quality program meets the stringent standards of medical device and pharmaceutical manufacturers worldwide. Quality assurance is built into everything we do, from order entry to contract review, from document control to training programs, from design control to validation

Key Features

 EN ISO 13485 and EN ISO 9001 certified 
 Work according to EU and FDA GMP directives
 Automated statistical process control (SPC) system
 Bacteriological testing of Class 7 and 8 cleanrooms
 On-line inspections that meet MDM standards
 Corrective and preventative action (CAPA) and supplier corrective and preventative action (SCAPA) systems
 Documentation supporting all of our quality systems

 

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