Technical Packaging Manager

Slides:



Advertisements
Similar presentations
Medsafe – GMP update / release for supply / communicating quality issues Derek Fitzgerald Manager, Compliance Management 11 July 2013 RACI Pharmaceutical.
Advertisements

Research and Innovation Summary of MS questions on the Commission's proposal for DG Research & Innovation Research and Innovation Rules for Participation.
HACCP.
Food Contact Materials
Construction H&S Policy & Procedures 1 Health & Safety Policy & Procedures PRODUCT OVERVIEW.
Additives and Contaminants (incl. Flavourings, Extraction Solvents, Enzymes and Ionising Radiation) 30 March 2011.
Options for Regulation and the Impact of Regulation on the Marketplace 29 November 2005 Alan Kent
BRC Storage & Distribution Safety and Quality Management System Training Guide
TEMPUS ME-TEMPUS-JPHES
OHSAS 18001: Occupational health and safety management systems - Specification Karen Lawrence.
Contractors CDM Compliance Kit CDM Contractors CDM Compliance Kit PRODUCT OVERVIEW.
1 CS38010 Professional Issues Health and Safety at Work.
Hazard Analysis Critical Control Point (HACCP)
Huzairy Hassan School of Bioprocess Engineering UniMAP.
Codex Guidelines for the Application of HACCP
BRC Global Standards. Trust in Quality. Exploring the Standard BRC Global Standard for Packaging and Packaging Materials.
1 CHCOHS312A Follow safety procedures for direct care work.
Need GFSI? Your organization has been asked to achieve Certification to a GFSI recognized standard. Your Next Steps:
BRC Food Safety Quality Management System Training Guide
ICONN DEEWR Nanotechnology OHS Research and Development Program & Nanotechnology OHS Regulation Dr Howard Morris Nanotechnology OHS R&D Program.
Ashland Specialty Ingredients IFAC’s cGMP Audit Guide How the Food Ingredient Industry has Responded to FSMA and Food Safety Audits Priscilla Zawislak.
Prepared by: Taruna Navraksha Irfaan Shashi Food Quality & Certification.
Responsible CarE® Product Stewardship – Building Your Team David Sandidge Director, Responsible Care American Chemistry Council June 2010.
What is it? Why it is so important?
ICPHSO Conference Michiko Jo 18 February 2010 Enforcement Update: Recent developments in the EU.
GFSI Explained Your organization has been asked to achieve Certification to a Global Food Safety Initiative (GFSI) recognized standard. What does this.
Legislation and Establishment Requirements  Rules about how coffee drinks should be prepared, extracted and served.  Each establishment (or cafe) will.
Overview report of a series of FVO fact- finding missions and audits carried out in 2012 and 2013 in order to evaluate the systems put in place to give.
© by ConJaGO, Kirchheim/Teck Quality Assurance in the Private Sector Bärbel Jakobs 18 th – 20 th June 2007 Mojmirovce, Slovak Republic.
Presentation 4: How can I know if nanomaterials are used in my workplace?
Julian Carroll Managing Director
Food Safety Assurance August Scope of food quality & food safety The term “food” covers any unprocessed, semi- processed, or processed item that.
Important informations
Ergonomics Regulatory Requirements Bawan Saravanabawan, Labour Program, HRSDC February 4, 2008.
Technical Packaging Manager
P1 The implementation of virtual water within the European water policy : the basics for a legal and political analysis Teresa Elola Calderón Research.
Proposed Rule for Preventive Controls for Animal Food.
Proposed Rule: 21 CFR 507 Proposed Rule for Preventive Controls for Animal Food 1.
© 2009 Michigan State University licensed under CC-BY-SA, original at Traceability.
EU INITIATIVES ON MINING WASTE. Why an initiative on Mining Waste ? Key environmental issues: l Potential environmental risks during disposal m Safety.
Directorate General for Enterprise and Industry European Commission The New Legislative Framework - Market Surveillance UNECE “MARS” Group meeting Bratislava,
Visit us at E mail: Tele:
Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Training on standardisation Support to the Modernisation.
The New Legislative Framework
Awareness Training: ‘HARPC’ for Food Safety Complimentary Presentation by Quality Systems Enhancement 1790 Wood Stock Road Roswell GA E. mail:
Health & Safety in Construction 4A7 Design & the Built Environment John O’Connor.
BRC Packaging ISSUE 5 Global Standard for Packaging and Packaging Materials.
Regulating Winemaking Practice Additions in a Rapidly Evolving, Global Market Greg Hodson 7 th May, 2015.
The actors in the product supply chain and their obligations Giuseppina Bitondo European Commission, DG GROW.
FEFAC THE EUROPEAN FEED MANUFACTURERS CODE (EFMC) Bob Armstrong, Deputy President FEFAC.
THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS Responsibility in the handling of medical devices.
© Food – a fact of life 2009 Hazard Analysis Critical Control Point (HACCP) HACCP is a system which looks for and prevents potential problems before they.
We Contribute to Safe Food Packaging – Regulatory
The target: Regulated industries
National Food Control Systems
POST APPROVAL CHANGE MANAGEMENT PROTOCOLS IN THE EUROPEAN UNION
Author: Nurul Azyyati Sabri
We contribute To Safe Food Packaging - Realisation
EU draft Community Guide to Good Hygiene Practice for the use of animal feed in primary production « Workshop on feed safety, marketing and use of feed.
QUALITY ASSURANCE AND QUALITY CONTROL IN GENERICS
Overview of public participation in strategic decision-making in the UNECE area David Aspinwall.
Food Production Systems
TRACEABILITY REQUIREMENTS UNDER EU GENERAL FOOD LAW
Training on standardisation
GFSI Explained Your organization has been asked to achieve Certification to a Global Food Safety Initiative (GFSI) recognized standard. What does this.
BRC Packaging ISSUE 5 Global Standard for Packaging and Packaging Materials.
Link between Directive 98/34/EC and Regulation (EC) No 764/2008
ESS approach and support for Declaration of Conformity (CE-marking) Fredrik Håkansson ESS Accelerator Collaboration Board Meeting Trieste
Design for Hygiene  Selecting food contact materials
Management of Pollution Risks at Activity Cessation GROUP HSE RULE (CR-GR-HSE-421) EXECUTIVE SUMMARY This rule sets the HSE requirements for the management.
Presentation transcript:

Technical Packaging Manager GMP 2023/2006 and Compliance Joanna Griffiths Technical Packaging Manager BRC Global Standards 1

EU Legislation Framework legislation on food contact materials 1935/2006 Good Manufacturing Practice 2023/2006 Material specific legislation Regional legislation

Overview of EC Packaging Legislation This overview isn’t intended to scare anyone, and it is available from the europa.eu website You probably won’t be able to read this, but the visual is intended to show how the legislation is structured.

Overview of EU Food Contact Materials Legislation These are the two areas that I’m speaking about today and this table is intended to show the structure of the legislation surrounding Food Contact Materials. Framework Directive is at the top, and it’s clear that GMP legislation is intended to sit with it and be relevant to all of the specific material measures.

Overview of EU Food Contact Materials Legislation It’s important to note that the vast majority of legislation is associated with Plastics, with some focus on cellulose film and ceramics. The legislation for plastics is also relevant for coatings and is associated with migration limits, recycled material and recycled material content, as well as additives to the materials. For all other materials, paper and board, glass, metals etc., it is expected that specific measures may be put in place and the Framework Directive sets out those groups of materials.

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 So, to start with the Framework legislation - the Commission Regulation on Materials and Articles Intended to come into Contact with Food As such it relates to all materials that could possibly come into contact with food, materials like refrigerator linings, kitchen work surfaces, as well as items such as food packaging and consumer disposable products such as paper plates and plastic knives and forks. The crossover with the BRC Global Standard for Packaging is clear here, the Standard is applicable to all packaging and packaging materials.

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 The requirement of the Framework directive are based in Article 3. Requiring that… (read through slide) Active or intelligent packaging is permitted in the legislation as long as its function is not to mask spoilage. It is very broad legislation, but it does supply three very pertinent questions for a packaging development technologist to ask his or her self when evaluating the suitability of packaging for a specific use.

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

Demonstrating Compliance Traceability at all stages of manufacture Traceability Process Control Packaging Print Control The requirements in these clauses require and facilitate traceability through all stages of production.

Other Provisions: Compliance Declarations Compliance declarations for relevant materials Written declaration to demonstrate compliance with specific legal requirements Available on demand

Demonstrating Compliance Declaration of Compliance Senior Management Commitment Specification and Document Control These requirements facilitate the evidence of compliance through a Declaration of Compliance for all finished products – packaging items. Senior Management Commitment is required by the Standard, and this is partially demonstrated through awareness of legal requirements and technical changes in industry. Specification and accurate documentation control can support the requirement of the Standard and the legislation.

GMP…

2023/2006 Focus is quality assurance Not jeopardising food safety or adversely affecting food Specific rules on inks and coatings Currently relevant in EU

Requirements Not specific, so a system should be in place to demonstrate good manufacturing practice Quality assurance system Quality control system Documentation The most noticeable feature of this piece of legislation is that it is very brief. There is no specific requirement. The legislation requires that a manufacturer is able to demonstrate GMP through a quality control system and the appropriate documentation The quality assurance system should take account of the site’s personnel, their knowledge and skills and the nature of the site. It should also be relative to the size of business, so nothing becomes too onerous on the company. The quality control system should monitor performance against GMP and identify any areas of failure to be able to correct them. The documentation requirements state that the business should maintain the appropriate documentation regarding specifications, manufacturing and processes that relate to the compliance and safety of the products.

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

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

Demonstrating Compliance Product Safety and Quality Manual Documentation “…appropriate documentation… with respect to specifications… and processing which are relevant to compliance and safety of the finished material.” Declaration of Compliance

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

Inks & Coatings Detailed Rules Process Control Eliminate set-off in formulation and handling No direct contact with food Process Control Controls can be set in place to ensure minimisation of risk of contamination

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

Thank you Hvala vam što ste