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GMP+ FSA scheme: an overview
Dik Wolters
Senior Policy Advisor
Jakarta, 14. July 2010
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Content
1. Structure of GMP+ FSA scheme
The different standards
2. Important elements in all standards Quality Management System, HACCP,Prerequisites, Other elements
3. Individual standards
GMP+ B1/GMP+ B2, B3 and B4
4. Certification
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Structure of GMP+ FSA scheme
A
General documents
B
Normative documents (standards)
C
Rules ofCertification
D
Interpretations and guidances
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Main, universal
standard
Standard for target groups
scopes B1B2
(2010)
B3
(2007)
B4
(2010)
Production compound feed
Production premixture
Production feed additives
Production feed material
Collection of feed materials
Storage and transhipment
Trade in animal feed
Road transport of animal feed
Affreightmentof transport
Structure of GMP+ FSA scheme
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Content
1. Structure of GMP+ FSA scheme
The different standards
2. Important elements in all standards Quality Management System, HACCP,Prerequisites, Other elements
3. Individual standards
GMP+ B1/GMP+ B2, B3 and B4
4. Certification
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Overview HACCP (~ ISO 22000 / Codex Alimentarius)
Quality management (~ ISO 9001)
Specific prerequisites for animal feed Product standards (~ EU Feed Law) Monitoring Integrated chain approach (as principle) Transparency Early Warning System (EWS) Traceability
Important elements (1)
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HACCP fully incorporated
Preliminary steps Establishing HACCP-team Specification of product & production proces
Establishing a prerequisite program
7 principles ofCodex1. Hazard analysis & establishing control measures2. Determination of critical control point (CCPs)
3. Establishing of critical limits4. Monitoring5. Corrective actions6. Verification7. Documentation
Important elements (2)
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Requirements for Prerequisite Programme
C
odex: `Without a good prerequisiteprogramme it is not possible toimplement a HACCP-plan succesfully`.
Precondition to apply HACCP succesfully
To create a basic hygiene level in thecompany
Important elements (3)
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Elements of a Prerequisite Programme
(PRP) Education and Training Infrastructure, Buildings and Working
Environment
Facilities and Equipment Cleaning and Maintenance Pest Control Administration and registration Etc.
Important elements (4)
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PRP creates
basic hygiene
level
Functioning of prerequisite programme
Hazard
Risk
Ranking
Almost all risks are controlled by control measuresthat are part of the Prerequisite Programme. For some risks specific control measures are
necessary.
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QM-system: ISO9001-based Commitment of Management Establishing of a QMS
Management responsibilities & resources Operational procedures, instructions & control Complaints, internal audit & review, improvement
QM-documentation/-manual
QM-system is meant to support theoperational HACCP-plan
Important elements (5)
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Product standards Traceability and Early Warning System
Monitoring Purchase of feed, raw materials andservices
Chain approach: Purchase only from certified suppliers For specific suppliers: application of so-called
gatekeeper protocol is an option
Important elements (6)
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In compliance with EU-feed law Safety requirements are incorporated
fully
Undesirable substances Carry-over of feed medicines Use of animal protein (Mad Cow Disease) Hygienic requirements (salmonella) HACCP
Reference to the trade requirements. Labelling etc.
Important elements (7)
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Schematic overview of
GMP+ QM-system
ISO-9001
Prerequisites
HACCP
Raw Materials Feed
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Content
1. Structure of GMP+ FSA scheme
The different standards
2. Important elements in all standards Quality Management System, HACCP,Prerequisites, Other elements
3. Individual standards
GMP+B1& GMP+B2, B3 and B4
4. Certification
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GMP+ B1
Covers all scopes especially production of
compound feed & premixtures
feed additives Structure is identical to ISO 9001 Where possible, same wording as ISO
9001
Easy to combine with ISO 9001
Intention for next year: adapt toISO22000-structure
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GMP+ B1
Chapter Content of GMP+ B1
1 Introduction
2 Normative references
3 Terms and definitions4 Feed safety system
5 Management responsibility
6 Management of resources (prerequisites)
7 Procescontrol (including HACCP)
8 Measurement, analysis and improvement
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Limited scope
Basic chapters are identical QMS, HACCP, prerequisites
Specific chapter for specific activities
Use of words focussed on target group
Identical structure, easy to combine
Achieves equivalent level of safety
assurance as when applying GMP+ B1
GMP+ B2, B3 and B4
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GMP+ B2, B3 and B4
Chapter GMP+ B2 GMP+ B3 GMP+ B4
1 Introduction
2 Normative references
3 Terms and definitions4 Feed safety system
5 Prerequisite programmes
6 HACCP
7 Control of operational activities forProduction Trade/storage Transport
8 Verification and improvement
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Content
1. Structure of GMP+ FSA scheme
The different standards
2. Important elements in all standards
Quality Management System, HACCP,
Prerequisites, Other elements
3. Individual standards
GMP+ B1/GMP+ B2, B3 and B4
4. Certification
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Finish
Questions & discussion
More information:
www.gmpplus.org