Production of Feed Materials Checklist GMP+ B2

Article Question Guidance Guidance Critical Guidance Major Guidance Minor

General
2.0 Does the company comply with The national and/or applicable EU Non compliance with
the applicable feed legislation? legislation and sector specific applicable legislation is
requirments a major NCR.

2.0 Does the company have a The national and/or applicable EU

procedure for implementing the legislation and sector specific
applicable feed legislation and requirments
GMP+ requirements?

2.0 Is the company registered and/or

approved by the competent
authority ?

Certification requirements
2.0 Does the company comply with #See A1, A2, A3 and A4.
the requirements specified in the
GMP+ A and C-documents?

4.3 Is the scope of the Feed safety B2: # The scope must in any event B2: # A section of the B2: # Not all non-GMP+
management system, including include all feed ingredients and all process is excluded activities are fully
any particularities or exclusions, activities which relate to this. # The with a reason. described.
been established and recorded? participant must also describe all
activities and/or products which do
not relate to feed.

Feed Safety Managment System

5.1.1 Are responsibilities and authority

established and recorded and
made known in writing within the
organisation?

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
4.4.1 Does management ensures that B2: # Description of the scope. # B2: # Not in accordance B2: # No full or correct
the feed safety policy complies HACCP documentation # Required with the norm in representation of what
with the required sections? GMP+ procedures, instructions and essential areas. happens in practice.
records.

4.4.1 Does the quality manual include Required sections: # Scope, including
the required sections? any details (Gatekeeper function and
products are described) and
exclusions. # Minimum required
GMP+ procedures or a reference. #
Description of the interactions
between processes. # Structure of
the documentation.

4.4.2 Have the relevant records and # Documentation must be reviewed B2: # Necessary B2: # Necessary
documents been established, at least every year by a competent modifications not modifications not
maintained and stored? person. # Documentation must implemented or not implemented or not
always be available to and fully and the situation fully but the situation in
understandable by the personnel in practice is behind the practice corresponds to
who have to carry out the current situation in the the regulations. #
requirements of the procedure. # company or the Relevant records have
Retention period for records is at regulations. # There is a been overlooked or are
least three years. backlog (> 2 months) in out of date (< 2
the relevant records. # months). # No up-to-
Records are not kept date description of the
for the required period method of archiving. #
of time. Relevant records are
not easily accessible.

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 Production of Feed Materials Checklist GMP+ B2
Article Question Guidance Guidance Critical Guidance Major Guidance Minor
4.3 Does the feed safety management
system which has been set up
meet the GMP+ requirements?

Personnel requirements
5.1.1 Is there an organisational chart #Authorities and responsibilities of
established and documented? the personnel

5.1.2 Are the employees competent and B2, B3: # This applies in particular to B2, B3: # Personnel do B2, B3: # No suitable
sufficiently qualified for the HACCP team and to the other not understand the record of the training
conducting the activities that are functions which influence feed procedures. # Principle courses, experience etc.
part of their tasks. Has this been safety. of HACCP is not known of employees. # Lack of
recorded and communicated? to the personnel. relevant refresher
training.

Infrastructure requirements

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
5.2.1/ Does the way the # If the environment/design/location
5.2.2.1 site/environment is located, does present risks the the customer
designed, constructed presents a must show by way of an analysis that
hazard to feed? the risks are satisfactorily
controlled.# Are the
wall/ceilings/floors designed,
constucted and finished to prevent
the accumulation of dirt, minimise
condensation and mould growth and
to facilitate cleaning?# Do doors
close properly and are proofed
against pests when closed?# Is the
lighting adequate?# Are there
sufficient areas for
loading/unloading/production/storag
e for feed/feed materials?

5.2.3 Has an access regulation been

established for the
production/trading areas?

5.2.4.2 Has the company evaluated the

risk of the airflow which can
possibly act as a means of
transport for pathogens and taken
the necessary precautions?

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
5.3.4 Did the company implement a B2, B3: # Permitted methods and B2, B3: # Insufficiently B2, B3: #
pest control programme according means. # Employees must have effective measures Demonstrability and
to the GMP+ requirements? permission in accordance with taken to deal with implementation not up-
national legislation to carry out pest vermin. to-date.
control operations. # Waiting times
are taken into consideration (for
example during fumigation)

5.3.5 Is waste and material which is not B2, B3: # Real risk that B2, B3: # Products
suitable for feed stored and waste and material which are not suitable
identified separately? which is not suitable for for delivery are not
feed becomes mixed identified.
with feed.

5.3.6 Is glass/breakable materials where

necessary protected against
breakage?

5.2.4.3 Is the quality of water, steam or # including additives for boilers,

ice suitable for the use in feed water treatment
production?

5.2.4 Have technical and organisational B2, B3: # Residue norms and the
measures been taken to prevent carry-over test in accordance with
cross-contamination and errors as GMP+ BA2 (if applicable)
much as possible?

5.2.4.4/ Do the processing aids and B2, B3: # Effects of residues of

5.2.4.5 packaging material not represent processing aids on the ready feed
any risk for feed safety? ingredients.

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
5.0 Has a reason/motivation been
given for the exclusion of the
prerequisites?

5.0 Does the company have an B2, B3: # Reason for excluded
effective prerequisite program? prerequisites. # The additional
prerequisites have been worked out
and implemented.

5.2.2.2 Are there sufficient areas for the B2, B3: # Contamination should be
reception and loading and avoided by creating good conditions.
unloading of feed ingredients and # The intrusion of rainwater and
for potentially harmfull products? contaminated water should be
prevented during loading, unloading
and storage

5.2.2.3 Are there sufficient areas for the B2, B3: # Suitable floors, walls and
storage of feed ingredients and for ceilings.
potentialy harmful products?

EWS and Recall

5.5 Is there a procedure available with In specific cases the customer must # The company omits
respect to EWS and has a recall- inform the customer, GMP+ to keep the competent
procedure been established and International and/or the Certification authority and GMP+
implemented? Body. # Working in accordance with International informed
GMP+ BA5. directly.

5.5 Was the recall simulation # After establishment of a recall

performed within the required procedure, a recall simulation should
timeframe? be carried out within 3 months. #
Thereafter a recall simulation every
year including the recording of
experiences #

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
Process control / HACCP
4.2 Has a HACCP team been # Carry out hazards analysis in B2, B3: # No B2, B3: # Poorly B2, B3: # Lack of
established with sufficient accordance with guidelines in operational HACCP functioning HACCP reasons for the
expertise from various disciplines chapter 6. # Should consist of team. team; no minutes from frequency of HACCP
and from all relevant feed related personnel from all the relevant the HACCP team team meetings. # Not
activities? business activities and positions and meeting. all departments
at least one member will have represented. # Function
demonstrable experience and of advisor not
knowledge of HACCP. established (if use is
made of this).

6.2.2 Are appropriate descriptions B2, B3: # This also applies to services
available for products (raw
materials) packaging materials,
etc.

6.2.3 Are appropriate descriptions B2, B3: #Wast flows and

available for applicable feed subcontracted process steps should
related processes? also be included in the flow diagram

6.2.1 Has the company determined and B2, B3: # Legal provisions and B2, B3: # Not in B2, B3: # No action B2, B3: # Not all norms
specified all the (safety) relevant GMP+ requirements. # possession of required taken as a result of are recorded, complete,
requirements with respect to the Customer requirements. # If the legal certificates, analysis results which applied or analysed.
feed ingredients to be produced? participant produces a feed material records or permits. are outside the
then it should be included in the Feed tolerances.
Support Products (FSP) with an
identical production method.

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
6.3.1 Has the company carried out a risk B2, B3: # This also applies to the B1, B1.2, B2, B3: # No B2, B3: # Not all risk
assessment of their described processes in the prior links such as risk estimation carried assessment hazards
processes covering all the raw materials and additives. out. # No hazards identified. # No
identified relevant hazards? analysis reasoning recorded. #
Not all hazards
specified

6.1 Has the company ensured that

one or more written procedures
on the basis of HACCP principles
have been introduced,
implemented and maintained?

6.4 Has the HACCP team established, B2, B3: # More than one control B2, B3: # The lacking of
recorded and implemented measure may be necessary to control a motivation for a CCP #
control measures and CCP's a risk and more than one risk may be Not all significant CCPs
(critical control points) with its controlled by a single control have been identified
critical limits, if applicable, for measure.
every risk documented on the risk
assessment?

6.5 Has the HACCP team determined B2, B3: #See GMP+ BA1
for each CCP which parameters
must be measured, analysed or
observed and which product
standards apply to these
parameters?

6.8.2 Has the the HACCP plan been # B2 Has it been documenten with
verified by the HACCP team? minimum frequency of once per year.

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
6.8.1 Has the HACCP plan been B1, B1.2, B2, B3: Part of the
validated by the validation team? validation team must consist of
independent persons beeing not a
member of the HACCP team

Internal audit
8.2 Does the company has a # Audit planning # Competency and
documented internal audit independency of internal auditors #
procedure which complies with Corrective actions and time-scales for
applicable frequency and their implementation are followed up
requirements? # were all relevant activities covered
by the scope of the internal audit

8.2 Does the company has a # Audit planning # Competency and B2 B3 B4: # Essential B2 B3 B4:#
documented internal audit independency of internal auditors # sections / departments Improvement measures
procedure which complies with Corrective actions and time-scales for were not audited. # from the internal audit
applicable frequency and their implementation are followed up Insufficient depth / are not demonstrably
requirements? # were all relevant activities covered insufficient reporting on monitored / followed
by the scope of the internal audit findings, improvement up.
measures not
demonstrable. #
Internal audit was
carried out more than a
12 months ago.

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
8.2 Has the company performed # Once per year B1 B1.2: # Essential B1 B1.2: #
internal audits with the required parts / departments Improvement measures
frequency? were not audited. # from the internal audit
Insufficient depth / are not demonstrably
insufficient reporting on monitored / followed
findings, improvement up.
measures in the
internal audit. #
Internal audit was more
than a year ago

8.2 Has the company performed

internal audits with the required
frequency?

Management review
8.3 Does the company has a # Required minimum inputs and
documented management review outputs
procedure which complies with
the requirements?

8.3 Has the company performed # Once per year

management review with the
required frequency?

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 Production of Feed Materials Checklist GMP+ B2
Article Question Guidance Guidance Critical Guidance Major Guidance Minor
4.1 Is management demonstrably B2: # Raising awareness of the B2: # No demonstrable B2: # No (quality)
involved in the development and importance of feed safety, management review objectives laid down.
the implementation of the feed compliance with the requirements of carried out.
safety management system? the customer and compliance with
the feed legislation. # Assemble the
HACCP team. # Make sufficient
resources available. # Management
review at least 1x/12 months.

8.3 Is there a regular assessment of

whether the feed safety
management system can be
improved?

Complaintprocedure/product
conformity
8.1 Is there a documented procedure B2 B3: # Complaints registration
for handeling of complaints which
complies with the requirements?

6.7 Have the nonconformities (in the B2, B3: # No procedure B2, B3: # The procedure
animal feed or process) with available or applied. is incomplete.
respect to this GMP+ standard
been established and controlled?

7.4.2 Is there a documented procedure

for handeling of non-conform
products which complies with the
requirements?

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
Sale and contract requirements

7.5 Are the specifications for the

product specification laid down in
a contract between the customer
and the buyer?

Cleaning requirements
5.3.3 Is there a documented cleaning B2: # Is the chosen cleaning method B2: # Hygienic
programm established and effective? # An authorised person operation
implemented which complies with must carry out the inspections with unsatisfactory
the requirements? respect to the status of the cleaning
and maintain a record of this.

7.7.1 After the transport is there B2: # Is there minimally worked in B2: # No cleaning B2: # The cleaning B2: Validation of the
cleaning and/or disinfection in accordance with the Procedures procedure available or procedure is effectiveness of
accordance with the Procedures GMP+ International published on the is not applied when incomplete or is not cleaning is not carried
GMP+ International published on IDTF website. # Has a control necessary. # No release adhered to properly. # out properly.
the IDTF website, does the programme been established and by competent authority Use of disinfection after
cleaning programme comply with implemented for the assessment of / inspection body after transport of products
the statutory and supplementary cleaning and disinfectant methods? a prohibited load and with cleaning regime D
requirements and are they before the transport of is not demonstrable. #
validated? animal feeds. No validation of the
effectiveness of
cleaning.

Inspection of load compartments

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
7.7 Before loading, is there an B2: # Visual checks of the loading B2: Participant does not B2: No record of visual B2: Records are present
assessment of whether the category are recorded. # If during a establish the product inspection. but incomplete.
loading compartment is clean, check, deviations are observed with category and the
free of load residues and the respect to the loading compartment cleaning regime.
odour of previous loads? then the judgement of the customer
should be recorded.

7.7.1 Has the company taken sufficient B2: Unintentional

measures to prevent undesired mixing and
contamination during transport? microbiological
contamination can not
be prevented.

Maintenance requirements
5.3.1 Has the customer drawn up and B2, B3: # Also agreements with B2, B3: # Structural B2, B3: # Incidental
implemented a documented external companies in relation to non-compliance with non-compliance with
programme of planned hygiene and safety. the established the established
maintenance for all the relevant procedure. procedure.
areas and equipment?

5.3.2 Are all equipment used for #Weighing and dosage equipment
inspection and measuring used to premixtures, feed additives and feed
confirm the specifications of the medicines must be calibrated twice
product were calibrated according per year. # For feed materials once
to the requirements? per year

Identification and traceability

requirements

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
5.4.1 Are the products traceable in all # The required information available B2, B3: # Insufficient B2, B3: # Difficult to
stages of production, processing within 4 hours unless the authorities records for tracking & trace.
and distribution? demand a faster time. # Minimum tracing.
required records: Name & Address,
date of delivery, type of product /
service, product quantity, batch
number. # Retention samples. # See
GMP+ BA13.

5.4.2 Are the retained samples of the B1, B1.2, B2, B3: # Sampling and
product complying with the storage in accordance with GMP+
requirements? BA13. # The samples must be sealed,
clearly identified, complying with the
minimum weigth requirements and
retention period .

Purchase requirements
7.1.1 Is there a documented procedures # Services: transport, Storage #
available for purchase of (raw) Specification of the (raw) materials,
materials, feed ingredients and/or feed ingrediants, services. # Supplier
services? assessment

7.1.2 What is the FSP Product number # See FSP Productlist

of all purchased or processed feed
materials?

7.1.2 Does the company comply with

the minimum purchase
requirements as stated in the
GMP+ BA10?

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
7.1.3 Has a written procedure been
established in which suppliers are
assessed and records are kept?

7.2 Is there an entry inspection on

purchased products and services?

7.7.3 Is roadtransport (on the orders of B2: # for the transport of packaged
service providers) carried out in raw materials or feed ingredients, the
accordance with the requirements external carrier and/or fright broker
of this standard? does not have to be GMP+ certified
or equivalent (risk assessments must
consider any potential hazards and
ensure that controls effectively
preclude any serious risk of
contamination). # Transport of
packaged raw materials or feed
ingredients must take place in a clean
and dry loading compartment. #
Under certain conditions sealed
loading units are considered to be
packaged products, therefore non-
certified external carriers can be used
(this is allowed when non-certified
external carrier has no influence on
the transported raw materials or feed
ingredients).

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 Production of Feed Materials Checklist GMP+ B2
Article Question Guidance Guidance Critical Guidance Major Guidance Minor
7.7.4 Is roadtransport carried out by B2: # Should the participant be
third parties/sub-contractor in instructed by a purchaser to load
accordance with the requirements transport that is considered
of this standard? unsuitable by the participant, he
must inform the purchaser of any
concerns (written confirmation of
such instructions from the purchaser
prior to loading, copies of associated
correspondence must be retained). #
A hazard analysis can provide
information with which the intensity
and the size of the checks could be
established

7.7.5 Is transport by inland waterway, B2: # Transport to a GMP+ B1 B2: # LCI not carried B2: # Freighting party
sea or train carried out in company: Freight brokerage of inland out does not contract out
accordance with the requirements waterways is GMP+ B4.2-certified; the LCI to an external
of this standard? carriers are GMP+ B4.3 certified; CO. # Loading taking
freight brokerage of sea transport is place in advance of the
GMP+ B4.4 certified; freight LCI.
brokerage of rail transport is GMP+
B4.5 certified. # Transport to other
companies: LCI by an inspection
agency at EN 17020 level or a
company loading inspector. The
affreightment party may not
undertake his own LCI.

Verification of received products

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 Production of Feed Materials Checklist GMP+ B2
Article Question Guidance Guidance Critical Guidance Major Guidance Minor
7.2 Is each incoming delivery of (raw) B2: # Does transport comply with the B2: # No proper entry
feed ingredients and feed verified requirements set (prior loads, check or sampling of
in accordance with an established cleaning, oil leaks). # In the event of delivered feed
procedure? doubt are the specifications verified materials.
using analyses.

Storage requirements
7.3 Do the storage and transhipment
activities of the customer comply
with the applicalbe GMP+
requirements?

7.3.1 Are there storage segregation B2: # Cross-contamination / mixing is

procedures in place to prevent avoided. # Use of legally permitted
cross-contamination of finished stock protection agents.
products, packaging and raw Documentation present. # Storage
materials? and transhipment activities are
contracted out in accordance with
the requirements of this standard. "

7.3.1 Are all products which are

produced or stored by the
participant but which are not
intended for use as a feed kept
separate from the feed
ingredients and identified as such?

Production requirements

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 Production of Feed Materials Checklist GMP+ B2
Article Question Guidance Guidance Critical Guidance Major Guidance Minor
7.4.1 Has the production been carried
out under planned and controlled
circumstances according to the
requirements?

7.4.1 Are the mixing of feed materials, B2: # Homogeneity conditions as

premixes, feed additives and established in BA2
veterinary medical products
complying with the requirements?

5.2.4.1 The implemented mesuares to #carry over test as stated in GMP+

control the cross-contamination in BA2 (if applicable)
order to meet the quality and
safety standards are complying
with the requirements?

Delivery and labelling

requirements
7.6 Is the product label complying # EC 767/2009
with the relevant requirements
(legal and from the standard)?

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 Production of Feed Materials Checklist GMP+ B2
Article Question Guidance Guidance Critical Guidance Major Guidance Minor
7.6 All the required information B1, B1.2, B2, B3: # Is this specification B2: No specifications B2: # No or insufficient B2: Specification is not
regarding the product delivery is and use available to the customer on labels. # No product up-to-date / complete.
according to the requirements? delivery. # On delivery the legally information made
prescribed information must be available to the
issued to the customer. # Does the livestock farmer for the
specification comply with the correct maintenance of the
composition of the product in hygiene of the feed. #
relation to type of animal and the Feed labels do not
latest date of feeding in GMP+ BA1 comply with the
and GMP+ BA3.# declaration of requirements. # Some
status of feeds placed on the market specifications are
or delivered services according to missing.
GMP+ FSA BA6

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 Production of Feed Materials Checklist GMP+ B2
Article Question Guidance Guidance Critical Guidance Major Guidance Minor
7.6 Does the company complies with # Statements for placing feed on the
the requirements for positive market:
declaration? The goods delivered are GMP+
assured
The goods delivered have the GMP+
status as specified in the GMP+ FSA
module
The feed delivered has the GMP+
status as specified in the GMP+ FSA
module
The feed to be delivered has the
GMP+ sta-tus as specified in the
GMP+ FSA module
The feed delivered is GMP+ FSA
assured
The feed to be delivered is GMP+ FSA
as-sured
GMP+ FSA assured
# Statements for delivery of service:
The service delivered has the GMP+
status as specified in the GMP+ FSA
module
The service to be delivered has the
GMP+ status as specified in the
GMP+ FSA mod-ule
The service delivered is GMP+ FSA
assured
The service to be delivered is GMP+
FSA assured
GMP+ FSA assured

Transport requirements

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
7.7 Are the transport requirements B1, B1.2, B2, B3, B4, B8: Does the
being fulfilled? transport of feed take place in a
clean loading compartment? #
Loading compartment is empty and
free of load remains and odour of
previous loads, dry. # No mixing of
animal feeds. # Covered, if necessary
# Products are easily identifiable
during transport

Monitoring and measuring

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
6.6 Has a monitoring plan been drawn B1 B1.2, B2, B3: # This plan applies to B1, B1.2, B2, B3: # B2, B3: # No records of B2, B3: # Records of
up in writing and has it been the processed materials up to and Analyses are carried controls and controls and
implemented complying with the including the produced feeds. # Is the out by an uncertified inspections at the inspections have a
requirements? reasoning for the monitoring laboratory. required points backlog of less than two
programme available and is it (backlog of more than months # No
demonstrably based on the product two months). # Non- description of the
norms GMP+ BA1 en GMP+ BA3. # Is standard number of method of sampling
there a check on whether products sample tests. # No full
comply with the product insight into whether the
specifications and the minimum laboratory complies
product requirements in GMP+ BA1 with GMP+ certification
en GMP+ BA3# Are proper measures for all analyses.
taken in the event of deviation from
the product specifications. # In the
event of the minimum requirements
in GMP+ BA1 en GMP+ BA3 being
exceeded is the product removed
from use and are proper records of
this maintained. # This plan must at
least comply with the inspections
established in this GMP+ FSA module.
# Laboratory must comply with the
requirements of the GMP+ FSA
module. See GMP+ BA10.

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 Production of Feed Materials Checklist GMP+ B2
Article Question Guidance Guidance Critical Guidance Major Guidance Minor
6.6 Have the necessary monitoring,
measurement, analysis and
improvement processes been
planned and implemented?

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