GMP+ B1 Production, Trade and Services

Art. Description Possible items for attention Freq. Interpretation nonconformity Critical Interpretation nonconformity `Major Interpretation nonconformity Mino
02 FEED SAFETY MANAGEMENT SYSTEM OBJECTIVE
2.0 Objective
2.1 Does the company comply with the #See A1, A2, A3 and A4. 3
requirements specified in the A documents?

2.2 Does the participant comply with community 3

legislation, national legislation, good
manufacturing practices and sector specific
feed safety standards?

2.3 Has the participant a procedure to 3

guarantee continuously compliance with
applicable feed safety legislation and sector
specific requirements?

2.4 Does the FSMS ensure continuous 3

compliance with applicable feed safety
legislation and sector specific requirements?

Art. Description Possible items for attention Freq. Interpretation Category 1 Interpretation Category 2 Interpretation Category 3
04 FEED SAFETY MANAGEMENT SYSTEM
4.1 Requirements for the Feed safety
management system
4.1 Does the Feed safety management system # At a single location there are multiple 3 Part of the process excluded without Not all non-GMP activities are fully
which has been set up meet the companies within the framework of GMP+, reason. described.
requirements of this GMP+ standard? see A1 (subarticles 4.1.a.6 up to 4.1.a.8). #
Quality assurance of storage in accordance
with the requirements in GMP+ BA10. #
Written notification if the handled feeds are
non-GMP-certified. # external carrier for the
transport of packaged raw materials does
not have to be GMP+ certified or
equivalent. # Under certain conditions
sealed loading units are considered to be
packaged products (when non-certified
external carrier has no influence on the
transported raw materials or feed
ingredients).

4.2 Documentation

GMP+ B1
© GMP+ International 1
Version: 1st of January 2015
 4.2.1 Is the Feed safety management system Required sections: # Documented 3 Not in accordance with the norm in No full or correct representation of w
documented and does it cover the required statement of management involvement. # essential areas. happens in practice.
sections? Manual # Required GMP+ procedures. #
Required GMP+ records. # Documents for
effective planning, implementation and
control of the production process. #
Required permits, records and certificates
under the animal feed legislation (for
example registration within the framework
of the animal feed hygiene regulation) #
Gatekeeper feed additives: GMP+
requirements are guaranteed through a
contract with the original producer. #
Gatekeeper feed additives: HACCP dossier
complies with GMP+ BA10.

4.2.2 Does the manual include the required Required sections: # Scope, including any 3 Not in accordance with the norm in No full or correct representation of w
sections? details (Gatekeeper function and products essential areas. happens in practice.
are described) and exclusions. # Minimum
required GMP+ procedures or a reference.
# Description of the interactions between
processes. # Structure of the
documentation.

4.2.3 Is there a documented procedure for control 3 Necessary modifications not Necessary modifications not
of the Feed safety management system? implemented or not fully implemented implemented or not fully implemente
and the situation in practice is behind but the situation in practice correspo
current developments in the company to the regulations.
or the regulations.

4.2.4 Have relevant records been established, Storage period for records is at least three 3 # There is a backlog (> 2 months) in the # Relevant records have been
maintained and stored? years. relevant records. # Records arising overlooked or are out of date (< 2
from the Feed safety management months). # No up-to-date description
system are not storaged for the the archiving of relevant records. #
required period of time. Relevant records are not easily
accessible.

Art. Description Possible items for attention Freq. Interpretation nonconformity Critical Interpretation nonconformity `Major Interpretation nonconformity Mino

05 MANAGEMENT RESPONSIBILITY
5.1 Management commitment

GMP+ B1
© GMP+ International 2
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 5.1 Is management demonstrably involved in 3 No management involvement. Incomplete or no up-to-date
the development and the implementation of management statement.
the Feed safety management system?

5.2 Feed safety policy

5.2 Does management ensure that the feed 3
safety policy complies with the required
sections?

5.3 Planning

5.3.1 Have objectives been established with 3

respect to the safe production of animal
feeds?

5.3.2 Does management ensure that the Feed 3

safety management system is implemented
and maintained correctly and that its
working and cohesion is always retained?

5.4 Responsibility, authority and communication

on feed safety
5.4.1 Are responsibilities and authority
established and recorded by way of an
organisational chart and made known in
writing within the organisation?
This applies in particular to the HACCP 3
team and to the other functions which
influence feed safety.

5.4.2 Has a HACCP team been established with 3 No operational HACCP team. # Poorly functioning HACCP team. # # Meeting of HACCP team not minut
sufficient expertise from various different Insufficient / no meeting. properly. # Not all departments
disciplines? represented. # Function of adviser no
established.

5.4.3 Has a management representative been Responsibilities and authority of the 3 Not functioning in practice. Not formally established but function
appointed? management representative: # in practice.
Establishment, implementation and
maintenance of the feed safety system. #
Report results to the directors # Promote
awareness within the organisation.

5.4.4 Has it been established what resources are 3

required and are they available?

GMP+ B1
© GMP+ International 3
Version: 1st of January 2015
 5.4.5 Have suitable methods of internal 3 No demonstrable meeting structure # Frequency of meeting structure no
communication been established within the with respect to the Feed safety established. # No demonstrable
organisation? management system. provision of information with respect
changes to the Feed safety
management system.

5.5 Management review

5.5.1 Has management assessed and established 3
the effectiveness of the Feed safety
management system at least once per year?

5.5.2 Does the management statement include 3

the required information?

5.5.3 Does the result of the management 3

statement meet the requirements set?

Art. Description Possible items for attention Freq. Interpretation nonconformity Critical Interpretation nonconformity `Major Interpretation nonconformity Mino
06 PREREQUISITES PROGRAMME
6.1 General
6.1 Has a reason been given for the exclusion # The additional prerequisites have been 3
of the prerequisites? worked out and implemented.

6.2 Personnel
6.2.1 Are personnel competent and do they have # Rules must also have been established 3 # Tasks and responsibilities with No suitable record of the training
the necessary qualifications for carrying out with respect to eating, drinking and respect to the processing of feed requirements of employees.
the work involved in the package of tasks smoking in production areas. # Gatekeeper additives, veterinary medical products
and has this been recorded and feed additives: official responsible for the and/or hygienic working have not been
communicated? HACCP dossier complies with GMP+ made clear to the employees. #
BA10. Personnel do not understand the
procedures.

6.2.2 Has there been a determination of the skills 3 Principle of HACCP is not known to the Lack of relevant refresher training.
required by the personnel for carrying out personnel.
the work and is this maintained and
recorded?

6.3 Infrastructure

GMP+ B1
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 6.3 Has the infrastructure been determined, 3
made available and maintained to comply
with the feed requirements?

6.3.1 Does the environment and the production 3

buildings present no danger to the
production of feed materials?

6.3.2.1 Does the facilities meet the requirements of In this section there are various 3 # The facilities are such that
this GMP+ standard? requirements with which the facilities must unintentional mixing and
comply. microbiological contamination are not
prevented. # Influence on traceability.

6.3.2.2 Do the production areas meet the # In this section there are various 3 Influence on feed safety.
requirements of this GMP+ standard? requirements with which the production
areas must comply. # Record keeping of
silo / tank empty reporting

6.3.2.3 Do the recipients and the installations # Mixing installations, dryer / drying 3 # Influence on feed safety. # Monitoring # No complete updated documentati
comply with the requirements of this GMP+ installations, measurement facilities # and measurement do not correspond to of calibration without safety being at
standard? Weighing / dosage equipment is calibrated: the requirements. Calibration not # Records have a backlog of less tha
2x / year: equipment for premixes, feed carried out. # Records have a backlog two months.
additives and veterinary medical products. of more than two months.
1x / year: equipment for feed materials. #
The monitoring and measurement
installations are registered and checked for
validity.

6.3.2.4 Do the other facilities meet the requirements # Processing aids # Packaging material # 3 # No hazard analysis carried out for
of this standard. Water or steam processing aids.

6.4 Work environment

6.4.1 Are the production areas and equipment 3 Structural non-compliance with the Incidental non-compliance with the
used for the production and/or mixing established procedure. established procedure.
checked properly and regularly in
accordance with written procedures and
recorded?

GMP+ B1
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 6.4.2 Have cleaning programmes been introduced # Responsibilities, methods, frequency and 3 Hygienic operation unsatisfactory.
and is there registration? times of the cleaning must be stated. # The
residues of cleaning and disinfecting
agents must be kept as small as possible.

6.4.3 Is use made of effective programmes for the Pest control must be carried out by 3 Insufficiently effective measures taken Demonstrability and implementation
control of pest or harmful organisms and is qualified persons. to exclude vermin. up-to-date.
this recorded?

6.4.4 Is waste and material which is not suitable
for feed stored and identified separately?
# Hazardous concentrations of veterinary 3
medical products and contaminants must
be removed properly. # Participant must
make clear how waste and its removal are
controlled.
Real risk that waste and material which Products which are not suitable for
is not suitable for animal feed becomes delivery are not identified.
mixed with animal feed.

6.5 Identification and traceability

6.5 Are the products traceable in all stages of
production, processing and distribution?
# The required information available within 3 Insufficient records for tracking & Difficult to trace.
4 hours unless the authorities demand a tracing.
faster time. # Minimum required records:
Name & Address, date of delivery, type of
product / service, product quantity, batch
number. # Retention samples. # See GMP+
BA13.

6.6 EWS and Recall

6.6 Have written procedures been adopted for # After establishment of a recall procedure, 3 # The company omits to keep GMP+
EWS and recall? a recall simulation should be carried out International informed directly.
within 3 months. # Thereafter a recall
simulation every year including the
recording of experiences # In specific
cases the participant must inform the
customer, GMP+ International and/or the
Certification Body. # Working in accordance
with GMP+ BA5.

6.7 Production
6.7.1 Has the production been carried out under If forbidden feed materials are processed 3 # The standard for undesirable # The standard for undesirable
planned and controlled circumstances? or traded is there a direct report to GMP+ substances is breached, with a direct substances is breached, without direct
International. hazard for humans, animals and/or the hazard for humans, animals and/or the
environment, where no adequate environment, where no adequate
improvement measures have been improvement measures have been
taken. # Forbidden feed material taken. # No measures established and
processed or traded. implemented to prevent
recontamination.

GMP+ B1
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 6.7.1.1 In the event of direct drying does the No use of prohibited fuels as specified in 3 # Use of prohibited fuels (GMP+ BA3) # Use of fuel not based on a risk
participant select, on the basis of a risk GMP+ BA3. assessment.
assessment, only fuels which do not
compromise the safety of the animal feed?

6.7.1.2 Have technical and organisational measures 3

been taken to avoid cross-contamination
and faults as much as possible with respect
to the dosage of (raw) materials and are
there records of this?

6.7.1.3 Have feed materials, feed additives and Is the homogeneity standard met? 3 # Incorrect processing of feed additives # Incorrect processing of feed additives
veterinary medical products been mixed #See GMP+ BA2 or veterinary medical products or veterinary medical products
uniformly in the feed? (structural) (incidental)

6.7.1.4 Have the conditions been matched with # It is obligatory to include a Salmonella- 3 # Incorrect processing of feed additives # Incorrect processing of feed additives
respect to pelleting / expansion / extrusion killing step in production where poultry or veterinary medical products or veterinary medical products
to the stability of the processed feed feeds are involved. See GMP+ BA4. (structural) (incidental)
additives and veterinary medical products?

6.7.1.5 Does a carry-over inspection take place and # See GMP+ BA1. # Implementation in 3 # No carry-over test carried out on # No correct carry-over test carried o
is account taken of the production accordance with GMP+ International critical lines. # Insufficient foundation
sequence? testing procedure. See GMP+ BA2. with respect to flush charge (including
veterinary medical products). # No
foundation for residue norms.

6.7.1.6 Are internal return flows brought back into 3 # Traceability of return flows insufficie
the charge / run from which they came or
can it be derived from the records where
they are stored with a determination of
which return products may be included in
which products?

Art. Description Possible items for attention Freq. Interpretation nonconformity Critical Interpretation nonconformity `Major Interpretation nonconformity Mino
07 PROCESS CONTROL
7.1 Planning of the realisation of a safe feed
7.1 Does the participant ensure the introduction, 3
implementation and maintenance of
permanent, written procedures based on the
HACCP principles?

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 7.2 Requirements for the feed
7.2.1 Have requirements for the feed been
determined by the participant?
7.2.2 Have these feed requirements been
reviewed before an animal feed is delivered whether products comply with the product
and are there records of this?
7.2.3 Are there specifications (end product) per
animal feed (group)?
7.2.4 Have procedures been established and
implemented for communication with the
customer?
7.3 Process information
7.3 Have all flow diagrams and layouts been
verified by the HACCP team?
7.3.1 Do the flow diagrams follow all the steps
and are they accurately laid down?
7.3.2 Does the diagram shows the whole
infrastructure of the establishment?
7.4 Hazards analysis
GMP+ B1
Version: 1st of January 2015
# Are these requirements specified and has 3 Not in possession of required legal No action taken as a result of analysis Not all norms are recorded, complete
the associated use been determined. # certificates, records or permits. results which are outside the applied or analysed.
Does the specification comply with the tolerances.
correct composition of the product in
relation to type of animal and the latest
date of feeding in GMP+ BA1 and GMP+
BA3. # In the event of production of a feed
material there should be a risk assessment
present for this method of production in the
Feed Support Products (FSP).
# Is there a determination on delivery of 3
norms in GMP+ BA1. # On delivery do the
product requirements comply with the
negative list in GMP+ BA3. # Are specific
requirements checked by the company in
the end product. # Assessment of whether
a new product complies with the legislation
and regulations.
Is this specification and use available to the 3 No specifications. Some specifications are missing. Specification is not up-to-date /
customer on delivery incomplete.
Complaints registration 3
3 # No demonstrable verification carried
out. # No verification carried out after
changes.
3 Essential process steps are missing. Incomplete description of the current
production process.
3 # No record on the diagram. # Not
indicated where cross-contamination is
possible.
© GMP+ International 8
 7.4 Have all the potential hazards which may 3 No hazards analysis. Not all hazards specified
have an negative effect on feed safety been
systematically identified and assessed by
the HACCP team?

7.4.1 Has the HACCP team established an
acceptable level for each hazard?
# Established levels must at least comply 3
with statutory norms and norms laid down
in GMP+ BA1. # Based on the generic risk
assessment from the Feed Support
Products (FSP) (if applicable)

7.4.2 Have risk estimates been carried out and 3 # No risk estimation carried out. # Not all risk assessment hazards
documented for each identified hazard? identified. # No reasoning recorded.

7.5 Establishment of critical control points

(CCPs)

7.5.1 Has the HACCP team established, recorded 3 # Control measures not recorded.
and implemented control measures for each
established risk?

7.5.2 Has the HACCP team established, for each # CCPs should be supported. # Specific 3
control measure, whether this control measures should be monitored, validated
measure is the last measure in the process and verified.
of controlling this risk in question?

7.6 Standards

7.6 Have parameters and norms been There must be compliance with the
established per CCP? established productnorms and the residue
norms for (critical) feed additives and
veterinary medical products. See GMP+
BA1 and GMP+ BA2.
3 # Non-compliance with the residue One of the elements has not been
norms for critical feed additives and correctly evaluated.
veterinary medical products.

7.7 Monitoring and measuring

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 7.7.1 Has a monitoring plan been drawn up in
writing and has it been implemented?
7.7.2. Has there been a check that the established Must take place at least after measurement 3
residue norms for feed additives and
veterinary medical products are not
exceeded?
7.8 Corrective actions
7.8 Have the non-conformities (in the animal
feed or process) with respect to this GMP+
standard been established and controlled?
7.9 Validation of the HACCP plan
7.9 Has the HACCP system been validated by
an independent validation team?
7.10 Purchasing
7.10.1 Do purchased products and services comply
with the specified purchasing requirements,
has a written procedure been established in
which suppliers are assessed and records
are kept?
GMP+ B1
Version: 1st of January 2015
# This plan applies to the processed 3 Analyses are carried out by an # No records of controls and # Records of controls and inspection
materials up to and including the produced uncertified laboratory. inspections at the required points. have a backlog of less than two mon
feeds. # Is the reasoning for the monitoring (backlog of more than two months). # # Analysis schedule not correct / up t
programme available and is it Deviating numbers of mandatory date. No description of the method o
demonstrably based on the product norms samples to be taken, sample testing sampling. # No check on storage life
GMP+ BA1 en GMP+ BA3. # Is there a and carry-over testing. # No full insight premixes and feed additives.
check on whether products comply with the into whether the laboratory has
product specifications and the minimum certification for all analyses.
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.
of carry-over.
3 No procedure available or applied. The procedure is incomplete.
# If it is impossible to put together an 3
independent validation team then this must
be explained.
# Required status of the product or service. 3 # Use of and purchasing from # Suppliers not assessed. # No Suppliers insufficiently assessed.
If the participant wants to purchase an uncertified suppliers (products and procedure available or applied. #
assured product or service (GMP+ assured services). # Absence of a risk Suppliers with an expired GMP+
or equivalent), it is his responsibility to assessment for a feed material. certificate
specify as such in the contract or another
official document. This specification is –of
course- not applicable when an accepted
gatekeeper option for purchasing is
applied. See GMP+ BA10.
© GMP+ International 10
 7.10.1 Does the participant comply with the
additional requirements for the purchase of
feed additives under gatekeeper conditions?
7.10.1 Does the participant comply with the
additional requirements for the purchase of
grains, seeds and legumes from uncertified
origin?
7.10.1 Does the participant comply with the
additional requirements for the purchase of
palm oil from uncertified origin?
7.10.2 Have the purchasing data for a product or
service to be bought been described in
which the suitability of specified purchasing
requirements is guaranteed?
7.10.3 Is there an entry inspection on purchased
products and services?
7.11 Production
7.11.1 Is the property of the client controlled,
handled, assessed and secured in the same
way as own products?
7.11.2 Does the feed continue to comply with the
requirements set during internal handling
and delivery to the intended destination?
GMP+ B1
Version: 1st of January 2015
See GMP+ BA10. 3
See GMP+ BA10. 3
See GMP+ BA10. 3
Purchasing requirements must be based 3 No specifications. Specifications incomplete
on the requirements which are set on the
end product. # Participant is responsible to
specify if feed or service must be covered
under GMP+ or equivalent certificate.
# Veterinary medical products must be 3 Structural contravention of the statutory # Contravention of the statutory rules
received and processed in accordance with rules with respect to the use of with respect to the use of veterinary
the applicable statutory provisions. # veterinary medical products. medical products in feeds. # No proper
Gatekeeper feed additives: product is in the entry check or sampling of delivered
original packaging. # Does the transport feed materials. # No purchasing
meet the requirements set (minimum check requirements or specifications check on
on the GMP+ certification of the carrier, supplied products. # No / insufficient
compliance with loading sequence, prior check on whether vets complete
loads and implementation of necessary certificates correctly.
cleaning regimes). # LCI report is
demonstrable
3
3 # No or insufficient labels # No product
information made available to the cattle
farmer for the maintenance of the
hygiene of the feed. # Feed labels do
not comply with the requirements.
© GMP+ International 11
 7.11.3 Before starting loading (of transport on the # The mandatory statutory information must 3
instructions of the customer) is there an be provided on delivery to the customer. #
assessment of whether the loading If during a check, deviations are observed
compartment is clean, free of remains of with respect to the loading compartment
loads and of the odour of previous loads and then the judgement of the customer should
is there feedback to the customer if there be recorded.
are deviations?

Art. Description Possible items for attention Freq. Interpretation nonconformity Critical Interpretation nonconformity `Major Interpretation nonconformity Mino

08 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 General
8.1 Have the necessary monitoring, 3
measurement, analysis and improvement
processes been planned and implemented?

8.2 Internal audits

8.2 Are internal audits carried out and registered 3 # Essential parts / departments were # Improvement measures from the
at least 1x / 12 months? not audited. # Insufficient depth / internal audit are not demonstrably
insufficient reporting on findings, monitored / followed up.
improvement measures in the internal
audit. # Internal audit was more than a
year ago

8.3 Verification of the Feed safety management 3

system

8.3 Does verification of the Feed safety # Gatekeeper feed additives: audit at the 3
management system take place and is there producer by or on behalf of the client. #
a record of this? Verification of the HACCP system.

8.4 Improvement

8.4.1 Is the effectiveness of the Feed safety 3

management system continuously
improved?

8.4.2 Are measures taken to resolve the sources 3 Insufficient action taken: no testing Insufficient testing records or monito
of non-conformities (corrective actions) and carried out, no records or monitoring. # carried out. # Not reporting analysis
has this been laid down in a procedure? No action taken following a positive results with respect to mandatory
result. monitoring to the the GMP+ Monitori
database.

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 8.4.3 Are measures taken to resolve the sources 3
of possible future non-conformities
(preventive actions) and has this been laid
down in a procedure?

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© GMP+ International 13
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retation nonconformity Minor

retation Category 3

non-GMP activities are fully

bed.

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© GMP+ International 14
Version: 1st of January 2015
 or correct representation of what
ns in practice.

or correct representation of what

ns in practice.

sary modifications not

mented or not fully implemented
e situation in practice corresponds
regulations.

evant records have been

oked or are out of date (< 2
s). # No up-to-date description of
chiving of relevant records. #
ant records are not easily
sible.

retation nonconformity Minor

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© GMP+ International 15
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plete or no up-to-date
gement statement.

ting of HACCP team not minuted

rly. # Not all departments
ented. # Function of adviser not
ished.

rmally established but functioning

ctice.

GMP+ B1
© GMP+ International 16
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quency of meeting structure not
ished. # No demonstrable
ion of information with respect to
es to the Feed safety
gement system.

retation nonconformity Minor

table record of the training

ements of employees.

of relevant refresher training.

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© GMP+ International 17
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complete updated documentation
bration without safety being at risk.
ords have a backlog of less than
onths.

ntal non-compliance with the

ished procedure.

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nstrability and implementation not
date.

lt to trace.

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correct carry-over test carried out.

eability of return flows insufficient.

retation nonconformity Minor

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© GMP+ International 20
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 norms are recorded, complete,
d or analysed.

ication is not up-to-date /

plete.

plete description of the current

ction process.

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ords of controls and inspections
a backlog of less than two months.
ysis schedule not correct / up to
No description of the method of
ing. # No check on storage life of
xes and feed additives.

rocedure is incomplete.

ers insufficiently assessed.

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ications incomplete

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retation nonconformity Minor

ovement measures from the

al audit are not demonstrably
ored / followed up.

cient testing records or monitoring

d out. # Not reporting analysis
s with respect to mandatory
oring to the the GMP+ Monitoring
ase.

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