2010-07-14 jakarta gmp+ an overview dik

8/7/2019 2010-07-14 Jakarta GMP+ an overview Dik

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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






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



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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



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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.



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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



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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



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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.



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Schematic overview of

GMP+ QM-system

ISO-9001

Prerequisites

HACCP

Raw Materials Feed


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Content





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



2. Important elements in all standards

Quality Management System, HACCP,

Prerequisites, Other elements



4. Certification


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Finish

Questions & discussion

More information:

www.gmpplus.org

2010-07-14 jakarta gmp+ an overview dik

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