Production of Feed Additives 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 a
requirments 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 with a activities are fully
any particularities or exclusions, activities which relate to this. # reason. described.
been established and recorded? The 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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4.4.1 Does management ensures that B2: # Description of the scope. # B2: # Not in accordance with B2: # No full or correct
the feed safety policy complies HACCP documentation # Required the norm in essential areas. representation of what
with the required sections? GMP+ procedures, instructions happens in practice.
and records.

4.4.1 Does the quality manual include Required sections: # Scope,

the required sections? including 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.

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 # Records out of date (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

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

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

Infrastructure requirements
5.2.1/5.2. Does the way the # If the
2.1 site/environment is located, environment/design/location does
designed, constructed presents present risks the the customer
a hazard to feed? must show by way of an analysis
that 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/stor
age for feed/feed materials?

5.2.3 Has an access regulation been

established for the
production/trading areas?

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
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?

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

5.3.5 Is waste and material which is B2, B3: # Real risk that B2, B3: # Products which are
not suitable for feed stored and waste and material which not suitable for delivery are
identified separately? is not suitable for feed not identified.
becomes mixed 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 B2, B3: # Residue norms and the
organisational measures been carry-over test in accordance with
taken to prevent cross- GMP+ BA2 (if applicable)
contamination and errors as
much as possible?

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5.2.4.4/5. Do the processing aids and B2, B3: # Effects of residues of
2.4.5 packaging material not processing aids on the ready feed
represent any risk for feed ingredients.
safety?

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
unloading of feed ingredients conditions. # The intrusion of
and for potentially harmfull rainwater and contaminated water
products? 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 ceilings.
for potentialy harmful products?

EWS and Recall

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

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
5.5 Was the recall simulation # After establishment of a recall
performed within the required procedure, a recall simulation
timeframe? should be carried out within 3
months. # Thereafter a recall
simulation every year including the
recording of experiences #

Process control / HACCP

4.2 Has a HACCP team been # Carry out hazards analysis in B2, B3: # No operational B2, B3: # Poorly functioning B2, B3: # Lack of
established with sufficient accordance with guidelines in HACCP team. HACCP team; no minutes reasons for the
expertise from various chapter 6. # Should consist of from the HACCP team frequency of HACCP
disciplines and from all relevant personnel from all the relevant meeting. team meetings. # Not
feed related activities? business activities and positions all departments
and at least one member will have represented. #
demonstrable experience and Function 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

available for products (raw services
materials) packaging materials,
etc.

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

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

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

6.3.1 Has the company carried out a B2, B3: # This also applies to the B1, B1.2, B2, B3: # No risk B2, B3: # Not all risk
risk assessment of their processes in the prior links such as estimation carried out. # assessment hazards
described processes covering all raw materials and additives. No hazards analysis identified. # No reasoning
the identified relevant hazards? 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 B2, B3: # More than one control B2, B3: # The lacking of a
established, recorded and measure may be necessary to motivation for a CCP # Not
implemented control measures control a risk and more than one all significant CCPs have
and CCP's (critical control points) risk may be controlled by a single been identified
with its critical limits, if control measure.
applicable, for every risk
documented on the risk
assessment?

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
6.5 Has the HACCP team B2, B3: #See GMP+ BA1
determined 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.

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

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

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

8.2 Has the company performed # Once per year B1 B1.2: # Essential parts / B1 B1.2: #
internal audits with the required departments were not Improvement
frequency? audited. # Insufficient depth measures from the
/ insufficient reporting on internal audit are not
findings, improvement demonstrably
measures in the internal monitored / followed
audit. # Internal audit was up.
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 outputs
review procedure which
complies with the
requirements?

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
8.3 Has the company performed # Once per year
management review with the
required frequency?

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 carried objectives laid down.
the implementation of the feed compliance with the requirements out.
safety management system? of 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 B2 B3: # Complaints registration
procedure for handeling of
complaints which complies with
the requirements?

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

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
7.4.2 Is there a documented
procedure for handeling of non-
conform products which
complies with the
requirements?

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 B2: # Hygienic operation
programm established and method effective? # An authorised unsatisfactory
implemented which complies person must carry out the
with the requirements? inspections with 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 is procedure is incomplete or effectiveness of
accordance with the Procedures GMP+ International published on not applied when is not adhered to properly. # cleaning is not carried
GMP+ International published the IDTF website. # Has a control necessary. # No release Use of disinfection after out properly.
on the IDTF website, does the programme been established and by competent authority / transport of products with
cleaning programme comply implemented for the assessment inspection body after a cleaning regime D is not
with the statutory and of cleaning and disinfectant prohibited load and demonstrable. # No
supplementary requirements methods? before the transport of validation of the
and are they validated? animal feeds. effectiveness of cleaning.

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
Inspection of load
compartments
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
assessment of whether the category are recorded. # If during establish the product inspection. present but
loading compartment is clean, a check, deviations are observed category and the cleaning incomplete.
free of load residues and the with respect to the loading regime.
odour of previous loads? compartment then the judgement
of the customer should be
recorded.

7.7.1 Has the company taken B2: Unintentional mixing

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

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

5.3.2 Are all equipment used for #Weighing and dosage equipment
inspection and measuring used premixtures, feed additives and
to confirm the specifications of feed medicines must be calibrated
the product were calibrated twice per year. # For feed
according to the requirements? materials once 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 B2, B3: # Insufficient records B2, B3: # Difficult to
stages of production, processing available within 4 hours unless the for tracking & tracing. trace.
and distribution? authorities demand a faster time.
# Minimum 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

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 Production of Feed Additives Checklist GMP+ B2
Article Question Guidance Guidance Critical Guidance Major Guidance Minor
7.1.1 Is there a documented # Services: transport, Storage #
procedures available for Specification of the (raw)
purchase of (raw) materials, materials, feed ingrediants,
feed ingredients and/or services. # Supplier assessment
services? B2: # Supplier is at the moment of
delivery either GMP+ or equivalent
certified (see GMP+ BA10) # Risk
assessment (on the basis of
HACCP) must be carried out prior
to the purchase of raw materials
or services. # Each feed material
which is purchased must be
included in the Feed Support
Products (FSP).

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?

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?

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
7.7.3 Is roadtransport (on the orders B2: # for the transport of packaged
of service providers) carried out raw materials or feed ingredients,
in accordance with the the external carrier and/or fright
requirements of this standard? broker 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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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 transport that is considered
requirements 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 out B2: # Freighting party does
sea or train carried out in company: Freight brokerage of not contract out the LCI to
accordance with the inland waterways is GMP+ B4.2- an external CO. # Loading
requirements of this standard? certified; carriers are GMP+ B4.3 taking place in advance of
certified; freight brokerage of sea the LCI.
transport is GMP+ B4.4 certified;
freight 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.

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

procedures in place to prevent is avoided. # Use of legally
cross-contamination of finished permitted 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?

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
Production requirements
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 BA2 (if applicable)
in 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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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
7.6 All the required information B1, B1.2, B2, B3: # Is this B2: No specifications B2: # No or insufficient B2: Specification is not
regarding the product delivery is specification and use available to labels. # No product up-to-date / complete.
according to the requirements? the customer on delivery. # On information made available
delivery the legally prescribed to the livestock farmer for
information must be issued to the the maintenance of the
customer. # Does the specification hygiene of the feed. # Feed
comply with the correct labels do not comply with
composition of the product in the requirements. # Some
relation to type of animal and the specifications are missing.
latest date of feeding in GMP+ BA1
and GMP+ BA3.# declaration of
status of feeds placed on the
market or delivered services
according to GMP+ FSA BA6

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Article Question Guidance Guidance Critical Guidance Major Guidance Minor
7.6 Does the company complies # Statements for placing feed on
with the requirements for the market:
positive 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 B1 B1.2, B2, B3: # This plan applies B1, B1.2, B2, B3: # B2, B3: # No records of B2, B3: # Records of
drawn up in writing and has it to the processed materials up to Analyses are carried out controls and inspections at controls and
been implemented complying and including the produced feeds. by an uncertified the required points (backlog inspections have a
with the requirements? # Is the reasoning for the laboratory. of more than two months). backlog of less than
monitoring programme available # Non-standard number of two months # No
and is it demonstrably based on sample tests. # No full description of the
the product norms GMP+ BA1 en insight into whether the method of sampling
GMP+ BA3. # Is there a check on laboratory complies with
whether products comply with the GMP+ certification for all
product specifications and the analyses.
minimum product requirements in
GMP+ BA1 en GMP+ BA3# Are
proper measures 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 Additives 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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