GMP 2023/2006 and Compliance Joanna Griffiths Technical Packaging Manager
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Transcript of GMP 2023/2006 and Compliance Joanna Griffiths Technical Packaging Manager
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GMP 2023/2006 and Compliance
Joanna Griffiths
Technical Packaging Manager
BRC Global Standards
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EU Legislation• Framework legislation on food contact
materials 1935/2006
• Good Manufacturing Practice 2023/2006
• Material specific legislation
• Regional legislation
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Overview of EC Packaging Legislation
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Overview of EU Food Contact Materials Legislation
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Overview of EU Food Contact Materials Legislation
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Scope of 1935/2004• The Framework Regulation
– Commission Regulation (EC) No. 1935/2004 on Materials and Articles Intended to come into Contact with Food (as amended)
• Applies to materials and articles which are: – Intended to be brought into contact with food– Already in contact with food and were
intended for that purpose– Reasonably expected to be in contact with
food under foreseeable conditions of use
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Requirements• Food contact materials should be
manufactured in such a way that they do not transfer constituents to food in quantities which would: – Endanger human health– Bring about an unacceptable change in the
composition of food– Bring about a deterioration in the organoleptic
characteristics of food
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Other Provisions: Traceability• Mirrors traceability requirements for food
producers, materials and articles– Treated as an ingredient
• Traceability at all stages
• ‘One forward, one back’ principle
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Demonstrating Compliance
Traceability at all stages of manufacture
• Traceability• Process Control • Packaging Print Control
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Other Provisions: Compliance Declarations
• Compliance declarations for relevant materials– Written declaration to demonstrate
compliance with specific legal requirements– Available on demand
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Demonstrating Compliance
Compliance
• Declaration of Compliance• Senior Management
Commitment• Specification and
Document Control
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GMP…
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2023/2006• Focus is quality assurance
– Not jeopardising food safety or adversely affecting food
• Specific rules on inks and coatings– Currently relevant in EU
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Requirements• Not specific, so a system should be in
place to demonstrate good manufacturing practice
– Quality assurance system– Quality control system– Documentation
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Demonstrating Compliance
Quality Assurance System
“total sum of… arrangements made with the purpose of
ensuring materials and articles are of the quality required to ensure conformity with the rules applicable to them.”
Quality Management Policy
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Demonstrating Compliance
Quality Control System“…ensure compliance of
starting materials and intermediate and finished
materials and articles with the specification determined…”
• Process Control, • Hazard and Risk Analysis
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Demonstrating Compliance
Documentation“…appropriate
documentation… with respect to specifications… and
processing which are relevant to compliance and safety of the
finished material.”
Product Safety and Quality Manual
Declaration of Compliance
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Inks & Coatings• Relevant due to Mineral Hydrocarbon
migration issues recent in EU
• Guideline on GMP for inks/coatings– Formulated/applied to prevent set-off
– Handled to prevent set-off
– Printed surfaces not in direct contact with food
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Inks & Coatings
Detailed Rules•Eliminate set-off in formulation and handling•No direct contact with food
Process ControlControls can be set in place to ensure minimisation of risk of
contamination
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Summary• Compliance with GMP requirements
depends on knowledge of industry
• Compliance with the BRC/IOP Global Standard for Packaging and Packaging Materials can aid and demonstrate compliance
• Legislation designed to minimise risk of current and future food safety issues arising from packaging
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