Storage and Transshipment of Feed Checklist GMP+ B3: General

Storage and Transshipment of Feed Checklist GMP+ B3
Article Question Guidance Guidance Critical Guidance Major Guidance Minor

General
2.0 Does the company comply with the The national and/or applicable EU Non compliance with
applicable feed legislation? legislation and sector specific applicable legislation
requirments is a major NCR.
2.0 Does the company have a procedure The national and/or applicable EU
for implementing the applicable feed legislation and sector specific
legislation and GMP+ requirements? requirments
2.0 Is the company registered and/or

approved by the competent authority
?
Certification requirements
2.0 Does the company comply with the #See A1, A2, A3 and A4.
requirements specified in the GMP+
A and C-documents?
4.3 Is the scope of the Feed safety

management system, including any
particularities or exclusions, been
established and recorded?
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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4.2 Did the management appoint an B3: "The person that is responsible for
employee to be responsible for feed quality: - establishes the Feed safety
safety and quality? management system - reports to top
management - ensures awareness of
feed safety in the organisation."
4.4.1 Does management ensures that the

feed safety policy complies with the
required sections?
4.4.1 Does the quality manual include the Required sections: # Scope, including
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 at

documents been established, least every year by a competent
maintained and stored? person. # Documentation must always
be available to and understandable by
the personnel who have to carry out
the requirements of the procedure. #
Retention period for records is at least
three years.

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

5.2.1/5.2. Does the way the site/environment is # If the environment/design/location
2.1 located, designed, constructed does present risks the the customer
presents 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/storage
for feed/feed materials?
5.2.3 Has an access regulation been

established for the storage 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?

5.3.4 Did the company implement a pest B2, B3: # Permitted methods and B2, B3: # B2, B3: #
control programme according to the means. # Employees must have Insufficiently Demonstrability and
GMP+ requirements? permission in accordance with national effective measures implementation not
legislation to carry out pest control taken to deal with up-to-date.
operations. # Waiting times are taken vermin.
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
identified separately? which is not suitable suitable for delivery
for feed becomes are not identified.
mixed with feed.
5.3.6 Is glass/breakable materials where

necessary protected against
breakage?
5.2.4 Is the quality of water, steam or ice # including additives for boilers, water
suitable for the use in the storage treatment
location?
5.2.4 Have technical and organisational B2, B3: # Residue norms and the carry-
measures been taken to prevent over test in accordance with GMP+
cross-contamination and errors as BA2 (if applicable)
much as possible?
5.2.4 Do the processing aids and packaging B2, B3: # Effects of residues of
material not represent any risk for processing aids on the ready feed
feed safety? ingredients.
5.0 Has a reason/motivation been given

for the exclusion of the
prerequisites?

5.0 Does the company have an effective B2, B3: # Reason for excluded
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 unloading avoided by creating good conditions. #
of feed ingredients and for The intrusion of rainwater and
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?
7.2.4 Is the presence of contaminants such B3: Sieving: - sieve maintenance plan, -
as glass, wood or earth in the feed person responsible for checks, -
limited as much as possible? random sample visual inspection of the
sieved batches
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
procedure been established and International and/or the Certification competent authority
implemented? Body. # Working in accordance with and GMP+
GMP+ BA5. International
informed directly.
5.5 Was the recall simulation performed # After establishment of a recall

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

Process control / HACCP
6.3 Have requirements for the feed been
determined by the participant?
6.2 Has a HACCP team been established # Carry out hazards analysis in B2, B3: # No B2, B3: # Poorly B2, B3: # Lack of
with sufficient expertise from various accordance with guidelines in chapter operational HACCP functioning HACCP reasons for the
disciplines and from all relevant feed 6. # Should consist of personnel from team. team; no minutes frequency of HACCP
related activities? all the relevant business activities and from the HACCP team meetings. # Not
positions and at least one member will team meeting. all departments
have demonstrable experience and represented. #
knowledge of HACCP. Function of advisor
not established (if use
is made of this).
6.3.2 Are appropriate descriptions B2, B3: # This also applies to services
available for products (raw materials)
packaging materials, etc.
6.3.3 Are appropriate descriptions B2, B3: #Wast flows and subcontracted
available for applicable feed related process steps should also be included
processes? in the flow diagram

6.3.1 Has the company determined and B2, B3: # Legal provisions and relevant B2, B3: # Not in B2, B3: # No action B2, B3: # Not all
specified all the (safety) GMP+ requirements. # Customer possession of required taken as a result of norms are recorded,
requirements with respect to the requirements. # If the participant legal certificates, analysis results which complete, applied or
feed ingredients to be produced? produces a feed material then it should records or permits. are outside the analysed.
be included in the Feed Support tolerances.
Products (FSP) with an identical
production method.
6.4.1 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 raw risk estimation carried assessment hazards
processes covering all the identified materials and additives. out. # No hazards identified. # No
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?
6.5 Has the HACCP team established, B2, B3: # More than one control B2, B3: # The lacking
recorded and implemented control measure may be necessary to control a of a motivation for a
measures and CCP's (critical control risk and more than one risk may be CCP # Not all
points) with its critical limits, if controlled by a single control measure. significant CCPs have
applicable, for every risk documented been identified
on the risk assessment?

6.6 Has the HACCP team determined for B2, B3: #See GMP+ BA1
each CCP which parameters must be
measured, analysed or observed and
which product standards apply to
these parameters?
6.9.2 Has the the HACCP plan been verified # B3 Has it been documenten with
by the HACCP team? minimum frequency of once per year.
6.9.1 Has the HACCP plan been validated B1, B1.2, B2, B3: Part of the validation
by the validation team? team must consist of independent
persons beeing not a member of the
HACCP team
7.2.6 Are other activities, if any, controlled B3: See paragraph 1.3 for the other
on the basis of the HACCP principles? activities which are allowed to be
carried out with this certificate.
Internal audit
8.2 Does the company has a documented # Audit planning # Competency and
internal audit procedure which independency of internal auditors #
complies with applicable frequency Corrective actions and time-scales for
and requirements? their implementation are followed up
# were all relevant activities covered
by the scope of the internal audit

8.2 Does the company has a documented # Audit planning # Competency and B2 B3 B4: # Essential B2 B3 B4:#
internal audit procedure which independency of internal auditors # sections / Improvement
complies with applicable frequency Corrective actions and time-scales for departments were measures from the
and requirements? their implementation are followed up not audited. # internal audit are not
# were all relevant activities covered Insufficient depth / demonstrably
by the scope of the internal audit insufficient reporting monitored / followed
on findings, up.
improvement
measures not
demonstrable. #
Internal audit was
carried out more
than a 12 months
ago.
8.2 Has the company performed internal # Once per year B1 B1.2: # Essential B1 B1.2: #
audits with the required frequency? parts / departments Improvement
were not audited. # measures from the
Insufficient depth / internal audit are not
insufficient reporting demonstrably
on findings, monitored / followed
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 documented # Required minimum inputs and
management review procedure outputs
which complies with the
requirements?
8.3 Has the company performed # Once per year

management review with the
required frequency?
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 for B2 B3: # Complaints registration
handeling of complaints which
complies with the requirements?
6.8 Have the nonconformities (in the B2, B3: # No B2, B3: # The
animal feed or process) with respect procedure available procedure is
to this GMP+ standard been or applied. incomplete.
established and controlled?

7.2.7 Has the company implemented a B3: The procedure comprises at any
procedure for dealing with deviating rate the following parts: #
products? identification of batch / lot ; #
documentation on management #
assessment of the cause of the
deviation; # separation of the batch /
lot concerned; #communication with
parties involved; preventive or
corrective actions to avoid repetition.
7.1.5 Is there a documented procedure for B3: The procedure should include: #
handeling of non-conform products identification of the batch; #
which complies with the documentation for the management of
requirements? the non-standard products; #
assessment of the cause of the non-
conformity; # separation of the batch;
#communication with the parties
involved; # preventive or corrective
actions to prevent reoccurrence of the
nonconformity.
Sale and contract requirements

7.1.6 Are the specifications for the product B3: The sepcification of feeds relates to
specification laid down in a contract safety requirments
between the customer and the
buyer?
Cleaning requirements

5.3.3 Is there a cleaning programm # Responsibilities # Cleaning mehods # B3: # Hygienic
established and implemented which Cleaning agents # Frequency of operation
complies with the requirements? cleaning unsatisfactory
Inspection of load compartments

7.3.1 Before loading, is there an B3: Unintentional
assessment of whether the loading mixing and
compartment is clean, free of load microbiological
residues and the odour of previous contamination can
loads? not be prevented.
7.3.1 Does transport lead to undesired B3: Unintentional

contamination of the feed? mixing and
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 maintenance hygiene and safety. the established the established
for all the relevant areas and procedure. procedure.
equipment?
5.3.2 Are all equipment used for inspection #Weighing and dosage equipment
and measuring used to confirm the premixtures, feed additives and feed
specifications of the product were medicines must be calibrated twice per
calibrated according to the year. # For feed materials once per
requirements? year
Identification and traceability

requirements

5.4.1 Are the products traceable in all # The required information available B2, B3: # Insufficient B2, B3: # Difficult to
stages of production, processing and within 4 hours unless the authorities records for tracking trace.
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
7.1.2.1 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
6.3.1 What is the FSP Product number of # See FSP Productlist

all purchased or processed feed
materials?

7.1.2 Does the company comply with the B3: #If the participant wants to
minimum purchase requirements as purchase an assured product or service
stated in the GMP+ BA10? (GMP+ assured or equivalent), it is his
responsibility to specify as such in the
contract or another official document.
7.1.3 Has a written procedure been B3: # The suppliers should be assessed
established in which suppliers are at least once a year. # For the
assessed and records are kept? assessment of growers its possible to
be assessed as a group of ídentical'
growers.
7.1.4 Is there an entry inspection on

purchased products and services?
7.3.1 Is roadtransport (on the orders of B3: # Is there minimally worked in B3: # No cleaning B3: # Cleaning B3: Validation of
service providers) carried out in accordance with the procedures GMP+ programme present or programme is cleaning effectiveness
accordance with the requirements of International published on the IDTF not implemented if incomplete or is not is not carried out
this standard? website. # Transport of packaged necessary. # No complied with satisfactorily
products is exempted from release by competent properly. # Use of
certification. authority / inspection disinfection after
body after a banned transport of products
cargo and for with cleaning regime
transport of feed. D is not
demonstrable. # No
validation of
effectiveness of
cleaning.

7.3.3 Is roadtransport carried out by third B3: See the GMP+ standard for the
parties/sub-contractor in accordance various requirements for transport
with the requirements of this within and outside the Netherlands
standard? and the see GMP+ BA10 Minimum
Requirements for Purchasing # If a
participant makes use of an external
carrier for the transport of packaged
feed then this external carrier and / or
fright broker does not have to be
GMP+ certified or equivalent (Risk
assessments must consider any
potential hazards). # 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 and therefore non-certified
external carriers can be used (allowed
when non-certified external carrier has
no influence on the transported raw
materials or feed ingredients).

7.3.4 Is transport by inland waterway, sea B3: # Transport to a GMP B1 company:
or train carried out in accordance Affreightment of inland waterways in
with the requirements of this Europe is GMP B4 certified; carriers
standard? within Europe are GMP B4.3 certified;
affreightment of sea transport is GMP
B4 certified; affreightment of rail
transport is GMP B4 certified. #
Transport to other companies: LCI by
an inspection agency at EN 17020 level
or a company loading inspector. The
shipper may not undertake his own
LCI.
Verification of received products

7.1.4 Is each incoming delivery of (raw) B3: # No proper
feed ingredients and feed verified in entry check or
accordance with an established sampling of delivered
procedure? feed materials. # No
purchasing
requirements or
specifications check
on supplied products.
Storage requirements
7.2.3 Do the storage and transhipment
activities of the customer comply
with the applicalbe GMP+
requirements?

7.2.3 Are there storage segregation B3: # Crosscontamination is prevented
procedures in place to prevent cross- # Check on fungus. # Usage of legally
contamination of finished products, allowed protectionagents is
packaging and raw materials? documented according to
requirements. #Storage and
transhipment at a third party will be
according to the requirements of this
standard.
7.2.2 Is each incoming delivery of feed B3: # Gatekeeper feed additives: B3: No proper entry
verified in accordance with the product is in the original packaging. # check or sampling of
established procedure? Does the transport meet the delivered feed
requirements set (minimum check on materials.
the GMP certification of the carrier,
compliance with loading sequence,
prior loads and implementation of
necessary cleaning regimes, oil leaks).
# In the event of doubt are the
specifications verified using analyses.
7.2.8 If the company stores feed by means B3: # Are the responsibilities clear /
of service, does the company meet demonstrable and verifiable? # Does
all relevant GMP+ requirements? the participant also comply with any
other requirements as agreed with the
client?
Production 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?
7.2.5 In the event of direct drying does the B3: # The fuels used for direct drying B3: Use of prohibited B3: Use of fuel not
customer select, on the basis of a risk are compliant with Appendix 1 of this fuels. based on risk
assessment, only fuels which do not standard.# Responsible person checks assessment.
compromise the safety of the feed? the moisture content after drying or
ventilation.# Implemented
maintenance plan for driers and fans.
Delivery and labelling requirements
7.1.7 Is the product label complying with # EC 767/2009

the relevant requirements (legal and
from the standard)?
7.1.3 All the required information # declaration of status of feeds placed

regarding the service delivery is on the market or delivered services
according to the requirements? according to GMP FSA BA6

7.1.7 Does the company complies with the # Statements for placing feed on 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+
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+
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

7.3 Are the transport requirements being B1, B1.2, B2, B3, B4, B8: Does the
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
7.3.5 If a third party is responsible for the

road transport, has the participant
taken reasonable precautions to
prevent potential hazards?
Monitoring and measuring

6.7 Has a monitoring plan been drawn up B1 B1.2, B2, B3: # This plan applies to B1, B1.2, B2, B3: # B2, B3: # No records B2, B3: # Records of
in writing and has it been the processed materials up to and Analyses are carried of 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
programme available and is it (backlog of more two months # No
demonstrably based on the product than two months). # description of the
norms GMP+ BA1 en GMP+ BA3. # Is Non-standard method of sampling
there a check on whether products number of sample
comply with the product specifications tests. # No full insight
and the minimum product into whether the
requirements in GMP+ BA1 en GMP+ laboratory complies
BA3# Are proper measures taken in with GMP+
the event of deviation from the certification for all
product specifications. # In the event analyses.
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.

6.7 Have the necessary monitoring,
measurement, analysis and
improvement processes been
planned and implemented?

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Storage and Transshipment of Feed Checklist GMP+ B3

Article Question Guidance Guidance Critical Guidance Major Guidance Minor

2.0 Is the company registered and/or

4.3 Is the scope of the Feed safety

Feed Safety Managment System

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4.4.1 Does management ensures that the

4.4.2 Have the relevant records and # Documentation must be reviewed at

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5.2.3 Has an access regulation been

5.2.4.2 Has the company evaluated the risk

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5.3.6 Is glass/breakable materials where

5.0 Has a reason/motivation been given

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EWS and Recall

5.5 Was the recall simulation performed # After establishment of a recall

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6.1 Has the company ensured that one or

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8.3 Has the company performed # Once per year

8.3 Is there a regular assessment of

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Sale and contract requirements

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Inspection of load compartments

7.3.1 Does transport lead to undesired B3: Unintentional

Identification and traceability

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6.3.1 What is the FSP Product number of # See FSP Productlist

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7.1.4 Is there an entry inspection on

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Verification of received products

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Delivery and labelling requirements

7.1.7 Is the product label complying with # EC 767/2009

7.1.3 All the required information # declaration of status of feeds placed

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7.3.5 If a third party is responsible for the

Monitoring and measuring

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