Packaging Certificates and Compliance
Site-specific certificates and documented standards help support supplier qualification, audit preparation, and regulatory documentation.
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.
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.
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ISO 15378:2018
GMP for primary packaging materials
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ISO 13485:2016
Quality management system for medical devices
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MDR 2017/745
EU Medical Device Regulation
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ISO 8317 /US16 CFR §1700.2
Child-resistant packaging
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ISO 9001:2015
Quality management system
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ISO Class 7
Cleanroom
compliant with ISO 14644-1 and EU GMP Annex I
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ISO Class 8
Cleanroom
compliant with ISO 14644-1 and EU GMP Annex I
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FSSC 22000
Food Safety
Management System
Need certification documents?
Scope and availability depend on production site, product category, and application.
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.
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ISO 14001:2015
Environmental management
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ISO 50001
Energy
management
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ISCC+
International Sustainability & Carbon Certification
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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.