Packaging Certificates and Compliance

Site-specific certificates and documented standards help support supplier qualification, audit preparation, and regulatory documentation.

Technician inspects plastic packaging sample with magnifier in a clean production setting.

Documentation support for packaging used in regulated industries

Selecting a packaging supplier often requires clear documentation for qualification, audits, and regulatory review.

ALPLApharma provides site-specific certificates and supporting documentation across pharmaceutical, medical device, food safety, cleanroom, and sustainability standards. As part of our quality approach, this documentation helps customers identify the information required for supplier approval, audits, and regulatory files. 

 

Internationally recognized standards

Site-specific certification scope

Documentation support

Pharmaceutical & Regulatory Standards

Production sites for pharmaceutical primary packaging operate under GMP-aligned conditions and certified quality management standards where applicable. These standards support consistent manufacturing processes, cleanroom operations, product quality, traceability and the documentation needs of customers.

  • ISO 15378:2018

    GMP for primary packaging materials

  • ISO 13485:2016

    Quality management system for medical devices

  • MDR 2017/745

    EU Medical Device Regulation

  • ISO 8317 /US16 CFR §1700.2

    Child-resistant packaging

  • ISO 9001:2015

    Quality management system  

  • ISO Class 7

    Cleanroom

    compliant with ISO 14644-1 and EU GMP Annex I

  • ISO Class 8

    Cleanroom

    compliant with ISO 14644-1 and EU GMP Annex I

  • FSSC 22000

    Food Safety 

    Management System

Need certification documents?

Scope and availability depend on production site, product category, and application.

Request documentation

Sustainability & Environmental Standards

Selected ALPLApharma sites are certified for environmental and energy management standards where applicable, reflecting the ALPLA Group’s commitment to responsible production.

For material and circular-economy options, ALPLApharma assesses feasibility in relation to regulatory, safety, quality, and performance requirements.

  • ISO 14001:2015

    Environmental management

  • ISO 50001

    Energy 

    management

  • ISCC+

    International Sustainability & Carbon Certification

  • RecyClass

    Recycled plastic certification

Certificate documents on request

Certificate documents are available on request. Scope and availability vary by production site, product category, and application.

Our quality team can help identify the relevant certificates and supporting documentation for supplier qualification, audit preparation, and customer regulatory files.

 

Request certificate documents

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