GMP Maturity · Good manufacturing practice for FCM compliance · Regulation (EC) No 2023/2006
Your FCM good manufacturing practice, measured against Regulation 2023/2006 and turned into an action plan.
10 themes, a 5-level scale. And the action that moves each level to the next.
The framework’s 10 themes, already written from L1 to L5. One company, one business unit, or 300 at once.
GMP Maturity · Good manufacturing practice for FCM compliance · Regulation (EC) No 2023/2006
10 themes, 5-level scale.
Nordhavn Industries
53 / 100
They measure their maturity with Datamensio
An example
This could be your situation.
Take one company as an example: three sites, three spreadsheets, no shared answer.
Nobody can consolidate.
Nordhavn Industries, 2,400 people in Hamburg, Lyon and Porto. A client asks where the group stands. Each site answers in its own spreadsheet, with its own scales.
Three weeks, a single base.
One Commission Regulation (EC) No 2023/2006 of 22 December 2006 assessment launched across all three sites at once, from the managers’ interview notes. The framework was already written, its 10 themes and levels L1 to L5 too.
Two costs avoided before being committed.
A score of 53 out of 100, with the gap concentrated on three themes. The AI companion spotted that two actions duplicated those of another audit. The committee report took one sentence to request.
What it saved them
- 3sites measured on the same base, instead of three questionnaires to reconcile
- 2duplicate actions caught before the spend
- 1committee report, with no manual rework
These figures are an example. They could be yours.
The standard imposes processes. Datamensio says where you stand.
01
The framework is already written
Themes, questions and levels L1 to L5, all written. You do not start from an empty spreadsheet.
02
The score lands the same day
Online, by self-assessment link or in interview. Theme by theme, comparable over time.
03
The gap becomes a costed plan
Every step up carries its action. The AI prioritises on expected effect, not on the order of the standard.
04
Progress can be demonstrated
Campaign after campaign, against your target and against your own past. That is what your board asks for.
The maturity scale
One level, the next, and the action that links the two.
This mechanism, a level, the level above, and the action linking the two, is what turns a finding into a trajectory.
Does the documentation allow the compliance of inputs and manufacturing parameters to be reconstructed for a delivered batch?
- N1
No batch record exists. Input and process information is not brought together and cannot be reconstructed after delivery.
- N2
Records exist, kept separately by production and quality, but their format varies and matching them to a delivered batch requires a case-by-case search.
- N3
A standardised batch record brings together input specifications, manufacturing parameters and control results. It is completed for all production runs, with occasional gaps.
- N4
The batch record is complete, checked before release and retained for a defined period. Upstream and downstream reconstruction is carried out on request within a set timeframe.
- N5
Reconstruction is tested periodically through a documented exercise, findings feed back into the revision of records, and the system is benchmarked across sites.
Action to move from L2 to L3
Define a single batch record template listing inputs, their compliance references, critical process parameters and control results, make it mandatory before release, and check it is properly completed during the monthly quality review.
« With Datamensio, we meet our objectives far more efficiently. The ERDF inspection services and our supervising ministry particularly appreciated an approach that gives them reliable data. »
Director, CCI 94CCI Île-de-France
« We believe this is the most suitable solution to scale our transformation project and measure impact according to our needs. »
Maja SucekChief Operating Officer, Interreg Danube
Rarely on its own
Frameworks combine. Put several together to cover your business, or have the AI write yours.
Take your first measurementon GMP.
What this framework covers
Regulation (EC) No 2023/2006 sets out the good manufacturing practice rules applicable to materials and articles intended to come into contact with food, known as FCM. It applies to every sector and every stage of the chain, from the manufacture of starting substances through processing and distribution, excluding the production of the starting substances themselves. It requires three things: a quality assurance system proportionate to the activity, a quality control system that verifies its implementation, and documentation that makes the whole thing auditable. Its annex adds detailed rules for printing processes, in particular the non-contact side.
In practice, this is a short text whose application is decided in the detail. The questions that keep coming up are concrete ones. Is the quality assurance system genuinely proportionate to the risks of the process, or is it a generic manual copied from another site? Are inks, adhesives and varnishes selected and traced with the same rigour as the primary raw material? Does the documentation allow the compliance of inputs, process parameters and control results to be reconstructed for a delivered batch? Many organisations have the pieces, scattered across quality, production and procurement, without any system linking them together.
One confusion is worth clearing up. Regulation 2023/2006 does not replace Regulation (EC) No 1935/2004, which sets out the general safety and inertness requirements for FCM, nor Regulation (EU) No 10/2011 on plastic materials and its lists of authorised substances. GMP is the organisational strand: it describes how to manufacture under control so that the compliance of materials is achieved repeatably. The declaration of compliance and migration testing fall under the other texts. A weak GMP system undermines the whole picture, including during customer audits in the food industry supply chain.
A maturity assessment answers a different question from a compliance audit. An audit asks: is the requirement met, yes or no. An assessment asks: what level of control does the practice sit at, and what specific action moves it to the next level. This progressive view makes it possible to prioritise, compare sites against each other and track the trajectory over time. It issues no certificate: it measures maturity and prepares the ground for scrutiny by regulators or clients.
Within Datamensio, the framework is ready to use and adaptable. The AI adjusts the themes, questions and levels to your process, printing, plastic, paper, metal or glass, or builds a variant from your own documents: quality manual, input specifications, control plans.
Reference standard: Commission Regulation (EC) No 2023/2006 of 22 December 2006
The themes assessed
Quality assurance system
Existence and scope of the system, proportionality to size and activity, roles and responsibilities, human and material resources, management review.
Control of raw materials and inputs
Specifications for starting substances, inks, adhesives and varnishes, compliance with applicable texts, supplier selection and evaluation, incoming inspection.
Control of manufacturing processes
Work instructions, critical parameters, settings and changeovers, control of temperature and drying conditions, management of production non-conformities.
Printing processes and non-contact sides
Application of the annex’s rules, ink formulation and application, absence of transfer through lamination or stacking, drying and residual solvents.
Quality control
Control plan, monitoring of GMP implementation, corrective actions, handling of deviations and complaints, review of the effectiveness of corrections.
Documentation and traceability
Specifications, manufacturing and control records, version control and retention periods, ability to reconstruct a delivered batch.
Premises, equipment and hygiene
Suitability of premises to the process, cleaning and maintenance of equipment, separation of flows, storage of contact materials and prevention of cross-contamination.
Personnel and competence
Training in FCM GMP, awareness of risks specific to food contact, authorisation for critical roles, ongoing skills updates.
Customer relations and supply chain
Passing information downstream, consistency with declarations of compliance, contractual client requirements, management of subcontractors and converters.
Continuous improvement and governance
Indicators tracked, internal audits, lessons learned from incidents, comparison across sites, ongoing updates to the system.
A short version of the framework is available for the online self-assessment.
Frequently asked questions
Does Regulation 2023/2006 lead to a certification?
No. It is a directly applicable EU regulation, overseen by competent authorities and checked through your clients’ audits. The Datamensio assessment measures the maturity of your system and prepares for that scrutiny, it does not issue any certificate.
What is the difference between this assessment and a compliance audit?
An audit concludes with a pass or a gap on each requirement. The assessment places the practice on a five-level maturity scale and points to the action that moves it to the next level. The two complement each other: the assessment prepares, the audit validates.
Who is covered across the FCM chain?
Every operator involved in manufacturing, processing and distributing contact materials and articles, except for the production of starting substances. Packaging manufacturers, printers, converters and distributors all fall within scope.
How long does the assessment take?
The short version can be completed in a single working session. The full version, run collaboratively with quality, production, procurement and regulatory affairs, typically takes one to two weeks, most of the time going into gathering the evidence.
Can the framework be adapted to our process?
Yes. The questions, levels and themes can be edited, and the AI can generate a variant specific to printing, plastic, paper and board, or metal, drawing on your own documents. You retain full control of the framework.
How does this assessment fit with 1935/2004 and 10/2011?
Regulation 2023/2006 covers the organisation of manufacturing, the other two cover material safety requirements and authorised substances. A cross-cutting roadmap can consolidate several assessments without duplicating actions.
Can several sites be compared?
Yes. The same framework is rolled out to each business unit, scores by theme can be compared across sites and over time, and gaps feed into a consolidated roadmap at group level.
Where is the data hosted?
In France, with OVH, backed up with Scaleway. No transfer outside the European Union. The AI models used can be selected, including from European providers.