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PLASTICS – PlasticsEurope, EuPC and CEFIC-FCA

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PLASTICS – PlasticsEurope, EuPC and CEFIC-FCA

Plastics Raw Materials

Starting or raw materials are approved using a specific procedure and then only approved materials are used.

Need to handle and store raw materials so as not to mix-them up or contaminate them

Need to be of good technical quality and purity based on their intended final use

Starting materials should be verified for acceptance before use

Materials that do not meet the acceptance criteria are identified and controlled to avoid their misuse

Water coming into contact with FCMs needs to be of suitable quality

Sufficiently detailed information provided. Could use additional information on requirements that supplier must meet (for example QA and GMP systems), though document does mention the importance of carrying out both internal and supplier audits, and specifications ensuring materials are QA – Quality Assurance

Adequacy of the personnel:

Importance of creating awareness at all levels involved

Management and personnel actively participate in an effective quality assurance system

Management responsibilities for GMP implementation are assigned, defined and documented

The personnel supervising or performing the manufacture or control of FCM should have the education, training and/or experience to perform the assigned tasks

Training of personnel should include a segment on GMP Organisation of premises and equipment:

There is sufficient and well-managed storage for starting and/or raw materials

There are adequate storage facilities to avoid contamination of FCM

1. Machinery and tools

Major equipment, transfer lines, containers and tanks that are used for processing, filling or holding FCM are identified either by labelling or using electronic control systems to indicate contents, batch designation, control status and other important information

Silo’s and bulk trucks can either be used only for FCM or these can undergo processes that ensure that they do not contain any contaminants or products

Machinery and tools for plastics

The equipment and set-up are adequate to avoid cross-contamination between materials or ingredients for food contact with those for non-food contact purposes. There are also cleaning and buffering procedures in place when transitioning from non-FCM to FCM to avoid contamination

2. Manufacturing processes

Require effective contamination prevention and compliance of composition and possible migrants being maintained throughout the production stages

In a factory where FCMs are produced as well as non-FCMs and where there is a risk that cross-contamination could harm the quality of the FCM, then production of FCMs needs to be flagged

There are procedures to ensure traceability from incoming starting material to outgoing FCM, which also take into account the use of raw materials recovered from a production process and the recording and traceability of their use

There is an adequate contamination prevention procedure based on a risk assessment

Raw materials need to be segregated from products ready for release, those awaiting release and those materials that are non-conforming or returns

Starting and/or raw materials should be monitored to verify their compliance and conformance with specifications

Every FCM product has one unique specification

Any work contracted out should be subject to a written contract and should be performed using GMP

Procedures are in place to ensure that transfer, packaging and loading are conducted in such a way so as to avoid product contamination Presence of pre-established instructions for the procedures: ~There is a system in which product formulation, operating procedures, operating windows, product release specifications and other critical information shall be documented

– Some useful information provided, with all areas if QA system covered. However, there is too little focus on the importance of having good communication between manufacturers and producers to ensure product is suitable for its desired end use and the need to draw attention to critical points of the production process, to ensure that the final product is compliant with legislative and technical requirements. Document does highlight the importance of avoiding contamination (especially when transitioning from non-FCMs to FCMs).

Plastics Quality Control QC

Monitoring the implementation and achievement of GMP:

A quality control department must exist with responsibility and authority to independently approve or reject all materials in the process

Documented specifications exist for starting and/or raw materials and finished products Corrective measures to remove any inefficiencies and non-compliance:

There is a system in place for recording and investigating complaints including product recall if needed and this investigation shall result in recommendations for corrective actions if needed

There is a procedure in place to respond to contamination

There is a procedure in place to ensure that non-conforming or recalled products are not released for food contact use without extensive investigation and proper authorisation

There is a procedure in place to ensure regular internal audits or self-assessments in order to monitor the implementation and respect of GMP Documentation:

There is a management of change procedure in case operating procedures have to be changed. The management of change procedure is capable of detecting and indicating potential changes in the composition or increased risk of contamination

The management of change considers changes in product formulations, starting/raw materials or suppliers of these materials

Plastics Quality Control QC

There are documented procedures to consider the impact of such changes on the final product quality, performance, composition and compliance.

Very detailed information. Could maybe use additional information on the importance of ensuring traceability throughout the production chain and information on the importance of documenting compliance of product and GMP of production but good information on the importance of conducting internal and supplier audits which monitor the implementation of GMP and the importance of having a QC department that has the authority to authorise or reject materials and that investigates complaints and product recall.

Plastics – Additional Information

3 main concepts of GMP:

Awareness at all levels involved in plastics production

Effective contamination prevention strategy (which ensures article’s composition remains compliant with legislation)

Effective management of change (procedures that monitor change in composition or contamination risk arising, which may eventually affect composition and migration of FCMs GMP emphasizes:

Personnel being trained on GMP

If a factory produces both FCM and non-FCM, then the production of FCM needs to be flagged

Need physical separation of a control system to segregate raw materials and products that have been released for use/distribution from materials pending release, non-conforming or product returns. There are also measures to ensure that the non-conforming or recalled products are not released for food contact use without investigation or proper authorisation

Plastics Personnel being trained on GMP

Packaging, loading and transfer operations are carried out in such a way to avoid contamination (ex. silo’s or bulk trucks are only used for FCMs or there are effective measures to ensure these containers do not contain any products or contaminants that would jeopardise the FCMs produced.

Procedures in place to ensure correct plastics labelling

There is a system that records and investigates complaints and plastics product recall.

Procedure in place to ensure that there are regular internal and supplier audits or self-assessments which will monitor the implementation and respect of GMP

Need a quality control department that has the responsibility and authority to independently authorise or reject materials

Need methods to ensure traceability from starting materials to final FCMs

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