The paper analyzes Good Manufacturer Practice GMP contents of documentation retrieved from Flexible and Fibre-Based Packaging Europe associations
The analysis reflects an overview of information on GMP from industry associations and refers to the coverage of the checklist for GMP (from EU Regulation (EC) 2023/2006). In general, FPE stands for the code of Good Manufacturing Practices for Flexible and Fibre-Based Packaging for Food.
GMP document designed for manufacturers of flexible and fibre-based packaging materials intended to come into contact with food (with these packaging materials being made of paper, board, regenerated cellulose, plastic film or aluminum foil or laminates of these materials. They may be printed, varnished, glued or converted (for example made into boxes).
The document covers the preparation of inks, varnishes and adhesives as well as the extrusion of plastic film and the metallizing of paper and plastic film.
Raw materials of Flexible and Fibre-Based Packaging
Raw materials shall only be purchased from suppliers who employ their own QA systems and GMP, which meet requirements
Raw material suppliers must assure the complete traceability of the composition and production methods of these materials and intermediates as well as the origin of the components (to assure that sources of possible mishaps can be identified and corrected and also allow manufacturers to rely on previous steps in the production chain)
Raw materials and their ingredients should be traceable up to the point where, for the first time in the production chain, the material is decided to be used in food packaging
Supplier must certify compliance with applicable legislation, recommendations and standards
The supplier needs to identify and quantify all components that have been allocated an SML, QM or QMA
Identify and quantify all components that are regulated as direct food additives or flavourings
Raw materials used must be certified or known from previous experience by the manufacturer to be organoleptically inert (for the specific food and use of the packaging)
Ensure that during production, handling, storage and transportation of the raw material, it does not become contaminated and maintains the desired quality
Traceability and certification of compliance (obtained through an independently audited quality assurance system of the supplier’s manufacturing process) of the raw materials is highly important
Unless otherwise specified, raw materials are used on a first in first out basis
QA – Quality Assurance of Flexible and Fibre-Based Packaging
Adequacy of personnel:
A suitable flow of information must occur along the whole supply chain from raw materials to packer/filler and food producer/brand owner so the packaging is designed with compliance in mind
The organisation of premises and equipment:
Rejected, recalled or returned raw materials or packaging shall be stored separately from certified and tested raw and packaging materials as shall materials waiting for approval or testing.
1.Machinery and tools
The choice of substrates, inks, varnishes, lacquers, other coatings, and adhesives should be based on recommendations from the raw materials suppliers and applied under conditions specified by them
Application of inks, varnishes and adhesives, as well as the production process, must occur in such a way to ensure that chemical cannot undergo an unintended chemical reaction and if a unintended reaction does occur, it does not give rise to potentially hazardous by-products.
Need to ensure correct setting of production parameters on machines such as drying temperatures and reel tensions
Final customer will be required to notify manufacturer if there are changes in the use or requirements of the packaging they request in case these changes bring about changes in the product’s performance.
Only inks certified for direct food contact may be used on the food contact surface of the packaging material (and in some EU countries, their use is not even permitted)
Require identification and control of potential sources of contamination during the production processes, storage, and transportation
Need to keep track of intermediate and finished products until they reach the customer’s warehouse
Potential sources of contamination during manufacture shall be identified and analysed and where appropriate, measures shall be taken to avoid contamination (for example control of pests and rodents or maintaining good hygiene practices in warehouses and modes of transportation)
Conditions during storage and transportation minimise deterioration of raw materials and packaging products
Need clear labeling and referral of raw and packaging materials to ensure constant traceability
Unless otherwise specified, products are sent out on a first produced, first out basis Presence of pre-established instructions for the procedures:
-Sufficiently detailed guidance, despite the lack of guidelines on requirement of having pre-established instructions for the procedures or anything on machinery and tools. Very detailed information on contamination prevention and on the importance of critical points being highlighted and controlled to ensure end-product is compliant. Also highlights the importance of communication between manufacturer and supplier.
QC – Quality Control of Flexible and Fibre-Based Packaging
Monitoring the implementation and achievement of GMP:
The quality assurance system shall be audited and certified periodically by an independent body
Supplier shall also maintain a quality assurance system (also subject to independent audits) capable of assuring GMP and compliance Corrective measures to remove any inefficiencies and non-compliance:
Complete traceability of the flexible and fibre-based packaging materials produced must be assured
When materials do not meet standards, these materials will be clearly segregated and identified (or disposed of if there is no means of correcting their faults)
A procedure should be in place which enables the manufacturer, in the event of a failure at any stage of the process or a complaint, to find the cause and rectify the problem as quickly as possible and if necessary, make amendments to the manuals or other controls to prevent such a problem repeating itself Documentation:
A written declaration of compliance shall be provided to the customers for all packaging materials (supplier can decide on his own whether he provides a certificate with each delivery or whether documentation is available via a web link for example). Decision on which method is used can be arranged between supplier and customer
The declaration shall be altered when substantial changes in the production bring about changes in the migration or when new scientific data are available
The business operator needs to have documentation to demonstrate that materials and articles, as well as substances intended for the manufacture, comply with regulation and shall be available to competent national authorities upon request. This documentation needs to contain conditions and results of testing, calculation, other analyses and evidence on the safety and compliance of the final product.
The GMP document is not a stand-alone document and can only be implemented in businesses that have a good, independently audited, quality assurance system. It must be ‘hooked onto’ and ’embedded in’ a system such as the ISO 9001.
This GMP document describes itself as ‘designing for compliance’ and with regard to the packaging products, focuses on the design, development and specification stages to ensure products almost unavoidably meet the criteria of the GMP document.
This document fills the gap in legislation with respect to multi-material multi-layer packaging and non-plastic materials by indicating where national legislation, standards, recommendations or guidelines from authoritative bodies should be applied.
This GMP document goes beyond existing legislation as flexible and fibre-based packaging materials are often composed of more than only plastics and therefore are not fully regulated by specific EU legislation. This means that manufacturers have no clear rules to abide by, but this document will resolve this issue by demanding compliance with food contact legislation of each component of the packaging material, which fully controls the composition of the FCM