GMP certificationscheme 2006 Production of feed

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GMP-certificationscheme 2006Production of feed

• Product Board Animal Feed
• Dik Wolters and Els van der Boon

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Why redesign the GMP programme?

• Reasons
• ISO 90011994 à ISO 90012000
• NL-HACCP Food has been updated
• Improve accessibility
• more logical sequence, remove duplicates
• National focus à international (EU)
• Ready for accreditation
• Change to Feed Hygiene Regulation (Reg. (EG)
  183/2005)

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Final result

• The GMP certification scheme is
• Up-to-date
• Applicable internationally
• Covers complete animal feed sector
• Is supported by the animal production chain
• 'Feed Hygiene Regulation'-proof

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Layout of the new GMP documents
participation
requirements
certificate
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Layout of the B documents standards
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Layout of the B documents standards
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Layout of the B documents appendices
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Layout of the B documents appendices
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B documents standards
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GMP B1 old to new

• Merging of 4 production standards

• No distinction by type of animal feed

• Also includes requirements for storage and trade

• Transport remains separate

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Scope GMP B1 Production Processing of Feeds

• All forms of physical interaction with animal
  feed
• grinding, mixing, pelletizing
• extrusion, expansion
• cleaning, drying
• bagging / packing
• internal storage and internal transport
• etc.
• All types of feed

• Also includes requirements for storage and trade

• Transport remains separate

Intended for producers!
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Scope GMP B3 Trade in animal feeds

• All trade ( purchasing and selling)
• administrative
• paper office
• All types of feed
• No requirements for production processing
• Storage simple processingà B1
• Intended for traders!

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Summary scope of the standards

• If in addition to production also trade or
  storage
• no problem, requirements included in B1
• If in addition to trade also storage or simple
  processing
• àB1
• If also transport à B4

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What does this mean for a company?(Art. 4.1)

• Describe the feeds the activities related to
  the feeds
• All feeds and activities for which there is a
  standard must be in system
• Describe the locations
• All locations where the feed activities take
  place must be in the system
• Describe other activities
• May not influence safety

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What does this mean for a company?(Art. 4.1) -
cont'd

• 4. Establish exceptions
• Paper trade in non-GMP feeds
• Pet foods
• 5. Establish contracted out work
• All activities for which there is a standard GMP
• All other matters under own control

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What does this mean for a company?(Art. 4.1) -
conclusions
v

• What is the scope of my system?
• Activities/feeds locations
• Which standard(s) must I apply?
• Which requirements must I apply?
• What is on the certificate?

v
v
v
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Specification of scope on certificate

• In accordance with fixed terminology
• Combination of activities and feeds
• Activities
• Derived from names of standards
• Animal feeds
• All animal feeds
• Goes on PDV website
• In free section you can specify

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Specification of scope on certificate

• In the free section you can specify, for example
• Production of poultry feeds
• Production of calves milk
• Collection and drying of grains

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Structure of GMP B1 Production

• Based on
• HACCP Foodstuffs NL
• ISO 9001-2000

ISO 22000

• Feed Hygiene Regulation
• Experience with GMP standards

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Amendments to the content

• New HACCP system
• Prerequisite programme integrated
• New ISO 90012000 content/structure
• Chapter layout
• Description changed in accordance with feed
  safety (instead of quality)

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Amendments to the content

• Addition of new requirements from the Feed
  Hygiene Regulation
• Requirements from Appendix II included
• Experience with GMP standards
• Basic qualityà feed safety
• Less administration such as procedures, lists
  and overviews

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General structure of the standard

• 8 chapters, as in ISO9001
• 1 to 3 Scope, definitions, etc.
• 4 Feed Safety System
• 5 Management Responsibility
• 6 Management of resources
• 7 HACCP Process control
• 8 Measurement, analysis and improvement

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What else is different in the standard?

• Specification of major changes per chapter
• Chapter 1 Subject and scope
• Chapter 2 Normative references .
• Chapter 3 Terms and definitions ..
• . have already been discussed

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What else is different in the standard?

• Chapter 4 Feed safety system
• Scope of the system (4.1) has already been
  discussed
• Fewer prescribed procedures (4.2)
• Control of calibration / maintenance of measuring
  devices
• Handling, storage and packaging
• Statistical techniques

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What else is different in the standard?

• Fewer mandatory lists (4.2)
• No list of suppliers
• No quarterly overview of analyses carried out
• No list of analyses carried out per laboratory
• Management statement no longer has to be send to
  certification body
• Keeping period for records (4.2)
• from 2 à 3 years

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What else is different in the standard?

• Chapter 5 Management responsibility
• More emphasis as a result of HACCP and the
  General Food Law
• Management review (5.5)
• more explicity summary of
• input (5.5.2) and
• output (5.5.3)

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What else is different in the standard?

• Chapter 6 Management of resources

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What else is different in the standard?

• Chapter 6 Management of resources
• Personnel (6.2)
• Good care because of feed safety
• Protective clothing if necessary
• Rules with respect to eating, drinking and
  smoking

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What else is different in the standard?

• Environment, buildings, production areas,
  equipment (6.3)
• Environment/terrain (6.3.1/6.3.2.1)
• Awareness of risks from the environment
• Production facilities (6.3.2.2)
• More explicit control of vermin
• Water which is used is safe for animals
• Sufficient light
• No admittance for unauthorised persons
• Visitors' regulations

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What else is different in the standard?

• Working environment (6.4)
• Covers the daily work activities
• cleaning and disinfection,
• vermin control,
• maintenance,
• waste control (new!)

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What else is different in the standard?

• Summary of Chapter 6
• Care for
• Good personnel
• Good facilities (including rooms, equipment)
• Work tidy and clean
• à prerequisites for successful application of
  HACCP (Chapter 7)

v
v
v
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What else is different in the standard?

• Chapter 7 HACCP Process control
• Prerequisite programme (7.1)
• included more explicitly in B1
• requirements can be found in chapters 67
• Control measures (7.6)
• General control measures
• part of prerequisite programme
• not linked to CCP
• previously point of attention

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What else is different in the standard?

• Control measures (7.6)
• Specific
• linked to CCP
• often measurable such as time and temp.
• supported by standards, monitoring and corrective
  actions

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What else is different in the standard?

• Validation (7.10)
• Does the HACCP system work?
• Verification assessment after
• Validation (new)rassessment before
• Hazards founded and complete
• Risk classification founded
• Control measures sufficient
• Monitoring plan adequate
• Corrective actions adequate
• by validation team
• HACCP team independent members

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What else is different in the standard?

• Chapter 8 Measurement, analysis and improvement
• More attention for continuious improvement
• Follows HACCP
• Consciously engaged
• compliance with chain requirements and
  legislation
• Corrective measure
• prevention of non conformities
• Corrective action (7.9)
• correcting non conformities

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What is new in the appendices?
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Appendix 4 Minimum requirements for inspection
and control

• Merging of GMP 18a b and action plans
• Protocols with standard layout
• Duplicates removed
• Report analyses results to the Undesirable
  Substances (DOS) Database
• Analysis obligation on feed materials for
  livestock companies has lapsed (except for
  Salmonella)
• Cross-reference table as aid (www.pdv.nl)

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Layout of the B documents appendices
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Appendix 10 Minimum Requirements for Purchasing

• Linked to 7.11 Purchasing
• Make sure you get what you ordered
• Strict requirements based on(7.11.1)
• Purchase animal feeds and services from
  GMP-certified companies
• Risk assessment published in Feed Materials Risk
  Assessment (DRV) database
• ( feed material can be controlled)

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Definitions

• Relationship between products and feeds
• Feeds
• Compound feeds
• Feed materials
• Feed additives
• Premixes
• Products also include
• Feed medicines
• Processing aids
• Cleaning agents
• etc.

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Appendix 10 Minimum requirements for
purchasinga) with GMP-certificate (7.11.1a)

• Compound feeds, premixes, feed materials and feed
  additives
• OO, transport, production processing, analyses
• Also bagging, packaging, contract production,
  storage, etc.

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Appendix 10 Minimum requirements for
purchasingb) with equivalent / approved
certificate (7.11.1b)
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Appendix 10 Minimum requirements purchasingc)
as Gatekeeper (7.11.1c)

• Producer is not GMP-certified
• As client you ct as guarantor
• Policy case by case (per type of animal feed
  and/or origin)
• Gatekeeper on extra conditions
• Checking takes place during audit at customer
• At this moment concrete requirements for
• Feed additives
• Products from grower (grain, seeds, legumes but
  also straw and hay)
• Some feed materials entry check

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Appendix 10 Minimum requirements purchasingc)
as Gatekeeper (7.11.1c)
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Appendix 10 Minimum requirements purchasingc)
other products/services (7.11.1d)

• self assessment and check
• assess and control the risks
• Silo cleaning
• Vermin control
• Cleaning and disinfection agents

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Practical consequences of the transition

• Manuals
• In accordance with new GMP B1 and/or
• By way of good cross-reference table
• Cross-reference tables as aids
• www.pdv.nl

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Transitional period GMP 2003 - 2006

• Per 1 January 2006
• GMP 2006 replaces GMP 2003
• 2006 transition year
• the two schemes run alongside one another in
  2006
• GMP participant certification body contract
  GMP 2006
• Audit on the basis of GMP 2006
• Certificate GMP 2003
• Certificate GMP 2006

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What is still to be changed or developed?

• Some GMP standards (cultivation, feeding)
• Residue norms (MRLs) and carry-over
• Uniformity of mixing
• Monitoring
• Gatekeeper for food
• Supplier assessment and selection
• Sampling protocols
• HACCP manual