ENG IFS GMP CHECK Version 1, April 2020

Company name:
COID:
responsible person (company):
Certification body / Auditor:
Date of check:
Time Start - End:

Products in production:
No Requirements based on IFS PACsecure V 1.1 evaluation Description Guidance for additional focus (GAF)
MOD: requirement modified only in the GMP Check (OK / not OK/ (mandatory for "not OK", Majior", "N/A", (The GAF is complementary to the regular topcis audited in each
Major) optional for "OK") requirement)
1 Senior Management Responsibility
1.2 Corporate structure
1.2.1 An organisation chart shall be available showing the structure of the company.

1.2.4 KO no.1: The senior management shall ensure that employees are aware of GAF: Awareness, business continuity and pandemic plan for the
KO their responsibilities related to packaging material safety and quality and current crisis.
that mechanisms are in place to monitor the effectiveness of their Examples of what should be asked:
operation. Such mechanisms shall be clearly identified and documented. – How is relevant information is transmitted to concerned persons?
– How is an effective distribution of information ensured?
– How is it ensured that employees know their responsibilities?
– How is deputation in case of sick leave organized?
– Have any additional measures implemented?
– How does the company ensure the all critical functions are covered by
competent personnel at all times?
– How is resource planning/provision of competent personnel ensured and
monitored?
– How is company keeping updated about authority restrictions related to
current crisis and in general?
1.2.9 The company shall ensure that all processes (documented and undocumented) GAF: Awareness, business continuity and pandemic plan for the
are known by the relevant personnel and are applied consistently. current crisis.
Examples of what should be asked:
– In case of new procedures/changes into existing procedures due to the
crisis, what is done to ensure that processes are known to relevant
personnel (incl. permanent staff and temporary/seasonal workers)?
2 Quality and Packaging Material Safety Management System
2.1 Quality management
2.1.1 Documentation requirements
2.1.1.3 All documents shall be clearly legible, unambiguous and comprehensive. They GAF: Availability of new, interims or modified of documents and safe
shall be available to relevant personnel at all times. access.
Examples of what should be asked:
– Are new, interims or modified procedures in regard to corona?
– If there are new, interims or modified documents: how are communicated
to relevant employees?
– How does the company ensure that all documents are available for
relevant persons avoiding personal contact also in work areas /areas
without electronic access?
NOTE: During GMP check, focus shall be on documents in production area.

2.1.2 Record keeping

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2.1.2.1 All relevant records necessary for the product requirements shall be complete, GAF: Availability of new, interims or modified of documents and safe
detailed and maintained and shall be available on request. access.
Examples of what should be asked:
– Are new, interims or modified records in regard to corona?
– If there are new, interims or modified records: how are communicated to
relevant employees?
– How are the records handled to avoid personal contact?
NOTE: During GMP check, focus shall be on documents in production area.

2.2 Packaging Material Safety Management

2.2.1 Hazard analysis and risk assessment system
2.2.1.1 The basis of the company’s packaging material safety control system shall be a GAF: Assess if the supporting management processes have been
fully implemented, systematic and comprehensive hazard analysis and/or risk maintained according to what has been defined in the Quality and
assessment system, based upon the Codex Alimentarius principles or on Packaging Material Safety Management System, legal and customer
industry guidelines. It shall take into account any legal requirements of the requirements.
production and destination countries which may go beyond such principles. The NOTE: This requirement must be considered as the backbone for multiple
hazard analysis and/or risk assessment system shall be implemented at each checks during this GMP check.
production site.
2.2.1.4 The hazard analysis and/or risk assessment system shall be reviewed and GAF: Hazard analysis and/or risk assessment system review in case of
necessary changes shall be made when any modification is made in the product, changes
process or any step. Examples of questions:
– Has the risk of coronavirus impact been considered on supply-
chain/products?
– What are the sources of information that have been considered to review
the hazard analysis/risk assessment system in regard to the coronavirus?

2.2.3 Hazard analysis and risk assessment

2.2.3.5.2 All risks that need specific monitoring and / or preventive actions shall be
(MOD) identified as Control Points (CP).
For each CP, clear limits and registration of the risk identification shall be
available
2.2.3.5.3 For all risks that are identified as Control Points (CP) to manage the identified
(MOD) risk, the company shall implement, maintain and document specific preventive
measures and monitoring procedures. Records of monitoring shall be checked
and maintained for a relevant period.
2.2.3.6 Establish corrective actions
For each CP corrective actions shall be established. In case the monitoring
indicates that a particular CP is not under control, adequate corrective actions
shall be taken and documented. Such corrective actions shall also take into
account any non-conforming products.
3 Resource Management
3.2 Human resources
3.2.1 Personnel hygiene
3.2.1.1 There shall be documented requirements relating to personnel hygiene. These GAF: Keep in mind to challenge pandemic plan in case key personnel is
include, as a minimum, the following fields: in on sick leave or quarantine. Focus on employee cross contamination
– protective clothing and how compliance in regard to personnel hygiene is checked
– hand washing and disinfection Examples of what should be asked:
– eating and drinking – Has hazard analysis been challenged in regards to Coronavirus? E.g. risks
– smoking related to physical contact in common areas like locker rooms or canteen,
– actions to be taken in case of cuts or skin abrasions etc.
– fingernails, jewelry and personal belongings – Have changes occurred based on the current pandemic? E.g. increased
– hair and beards. frequency for cloth changing, modifications in hand washing and disinfection
The requirements shall be based on hazard analysis and assessment of protocol, etc.
associated risks in relation to product and process. – How are the changes communicated to personnel, contractors and
visitors?

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3.2.1.2 KO no. 2: The requirements for personnel hygiene shall be in place and
KO applied by all relevant personnel, contractors and visitors.
3.2.1.4 Visible jewelry (incl. piercing) and watches shall not be worn. Any exceptions
shall have been comprehensively evaluated by hazard analysis and assessment
of associated risks in relation to product and process. This shall be effectively
managed.
3.2.1.5 Cuts and skin abrasions shall be covered by a colored plaster/bandage (different
from the product color)—containing a metal strip, where appropriate—and in
case of hand injuries, in addition to a plaster/bandage, a single use glove shall
be worn.
3.2.2 Working conditions and protective clothing for personnel, contractors and
visitors
3.2.2.2 In work areas where wearing headgear and/or beard snood (coverings) is
required, the hair shall be covered completely, so that product contamination is
prevented.
3.2.2.3 Clearly defined usage rules shall exist for work areas/activities where it is
required to wear gloves (colored differently from the product color). Compliance
with these rules shall be checked on a regular basis.
3.2.2.4 Suitable protective clothing shall be available in sufficient quantity for each
employee, when required.
3.2.3 Procedures applicable to infectious diseases
3.2.3.1 There shall be written and communicated measures for personnel, contractors GAF: Assessment of potential risks due to the current situation and
and visitors to declare any infectious disease which may have an impact on actions taken.
packaging material safety. In case of declaration of infectious disease, actions Examples of what should be asked:
shall be taken in order to minimize risk of contamination of products. – Have potential risks been assessed in regard to the current situation?
– Have rules been updated in regard to the current situation?
– How are the changes communicated to personnel, contractors and
visitors?
– What kind of actions are taken when a disease (or its symptoms) is
declared?
– Have restrictions for external personal been implemented?
3.4 Sanitary facilities, equipment for personnel hygiene and staff facilities

3.4.1 The company shall provide staff facilities, which shall be proportional in size,
equipped for the number of personnel and designed and operated so as to
minimize packaging material safety risks. Such facilities shall be kept in clean
and good condition.
3.4.4 The company shall provide suitable changing rooms for personnel, contractors
and visitors. Where necessary, outdoor clothing and protective clothing shall be
stored separately.
3.4.5 Toilets shall not have direct access to an area where packaging material
products are handled. The toilets shall be equipped with adequate hand washing
facilities. Sanitary facilities shall have adequate natural or mechanical ventilation.
Mechanical airflow from a contaminated area to a clean area shall be avoided.

3.4.6 Adequate hand hygiene facilities shall be provided at access points to and within
production areas, as well as at staff facilities. Based on hazard analysis and
assessment of associated risks, further areas (e.g. wrapping area) shall be
similarly equipped.
3.4.7 Hand washing facilities shall provide as a minimum:
– running potable water at an appropriate temperature
– liquid soap
– appropriate equipment for hand drying.

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3.4.8 If necessary, following additional requirements regarding hand hygiene shall also
be provided:
– hand contact-free fittings
– hand disinfection
– adequate hygiene equipments
– signage highlighting hand hygiene requirements
– waste container with hand contactfree opening.
3.4.10 Changing rooms shall be separated from production area and shall be situated
so that they allow direct access to the areas where packaging material products
are handled.
Based on hazard analysis and assessment of associated risks, exceptions shall
be justified and managed.
3.4.11 Where the hazard analysis and assessment of associated risks show the
necessity, cleaning facilities shall be available and used for boots, shoes and
further protective clothing.
4 Planning and Production Process
4.5 Product wrapping
4.5.5 The company shall ensure that the wrapping used corresponds to the product
being wrapped. The use of correct wrapping shall be regularly checked.

4.5.6 Printing and labeling information shall be legible, indelible and shall comply with
agreed customer product specifications or other legally required documentations.
This shall be regularly checked and checks shall be documented.

4.6 Factory location

4.6.1 The company shall investigate to what extent the factory environment (e.g.
ground, air) may have an adverse impact on product safety and product quality. If
product safety and quality could be compromised, appropriate measures shall be
established. The effectiveness of the established measures shall be periodically
reviewed (examples: extremely dusty air, strong smells).

4.7 Factory Exterior

4.7.1 The factory exterior shall be maintained to be clean and tidy.
4.7.3 Outdoor storage shall be kept to a minimum. Where goods are stored outside,
hazard analysis and assessment of associated risks shall be undertaken in order
to ensure that there is no risk of contamination or adverse effect on quality and
packaging material safety.
4.8 Plant layout and process flows
4.8.1 Plans clearly describing internal flows of finished products, packaging materials,
raw materials, waste, personnel, water, etc. shall be in place. A site map
covering all buildings of the facility shall be available.
4.8.2 The process flow, from receipt of goods to dispatch, shall be in place so that
contamination of raw materials, packaging, semi-processed and finished
products is avoided. The risk of cross-contamination shall be minimized through
effective measures.
4.8.3 In case of sensitive production areas, these shall be operated and monitored to
ensure product safety is not compromised.
4.8.4 Laboratory facilities and in-process controls shall not affect the product safety.

4.9 Constructional requirements for production and storage areas

4.9.1 Constructional requirements
4.9.1.1 Rooms where packaging material products are prepared, treated, processed and
stored shall be designed and constructed so that packaging material safety is
ensured.
4.9.2 Walls

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4.9.2.1 Walls shall be designed and constructed to prevent the accumulation of dirt, to
reduce condensation and mould growth, and to facilitate cleaning.
4.9.2.2 The surfaces of walls shall be in a good condition and easy to clean; they shall
be impervious and wear-resistant.
4.9.2.3 The junctions between walls, floors and ceilings shall be designed to facilitate
cleaning.
4.9.3 Floors
4.9.3.1 Floor covering shall be designed to meet production requirements and shall be in
good condition and easy to clean. Surfaces shall be impervious and wear-
resistant.
4.9.3.2 The hygienic disposal of waste water shall be ensured. Drainage systems shall
be easy to clean and designed to minimize the risk of product contamination (e.g.
ingress of pests, etc.).
4.9.3.3 Water or other liquids shall reach drainage without difficulties, using appropriate
measures. Puddles shall be avoided.
4.9.3.4 In packaging material handling areas, machinery and piping shall be arranged so
that waste water, if possible, goes directly into a drain.
4.9.4 Ceilings/Overheads
4.9.4.1 Ceilings (or, where no ceilings exist, the inside of roofs) and overhead fixtures
(incl. piping, cableway, lamps etc.) shall be constructed to minimize the
accumulation of dirt and shall not pose any risk of physical and/or microbiological
contamination.
4.9.5 Windows and other openings
4.9.5.1 Windows and other openings shall be designed and constructed to avoid the
accumulation of dirt and shall be maintained in good condition.
4.9.5.2 Where there is risk of contamination, windows and roof glazing shall remain
closed and fixed during production.
4.9.5.3 Where windows and roof glazing are designed to be opened for ventilation
purposes, they shall be fitted with easily removable, good condition pest screens
or other measures in order to avoid any contamination.
4.9.5.4 In areas where unpackaged product is handled, windows shall be protected
against breakage.
4.9.6 Doors and gates
4.9.6.1 Doors and gates shall be in good condition (e.g. no splintering parts, flaking
paints or corrosion) and easy to clean.
4.9.6.2 Based on hazard analysis and assessment of associated risks external doors
and gates shall be constructed to prevent the ingress of pests; if possible, they
shall be self-closing.
4.9.7 Lighting
4.9.7.1 All working areas shall have adequate lighting.
4.9.7.2 All lighting equipment shall be protected by shatter proof covers and installed to
minimise the risk of breakage.
4.9.8 Air conditioning/Ventilation
4.9.8.1 Adequate natural and/or artificial ventilation shall exist in all areas.
4.9.8.2 If ventilation equipments are installed, filters and other components which require
cleaning or replacement shall be easily accessible.
4.9.8.3 Air conditioning equipment and artificially generated airflow shall not lead to any
product safety or quality risks.
4.9.9 Water supply
4.9.9.1 Water which is used as ingredient in the production process, or for cleaning,
shall comply with legal requirements and shall be supplied in sufficient quantity;
this also applies to steam and ice used within the production area. A supply of
such water shall be available at all times.
4.10 Cleaning and disinfection

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4.10.1 Based on hazard analysis and assessment of associated risks, cleaning and
disinfection schedules shall be available and implemented. These shall specify:
– objectives
– responsibilities
– the products used and their instructions for use
– the areas to be cleaned and/or disinfected
– cleaning frequency
– documentation requirements
– hazard symbols (if necessary).

4.10.2 Cleaning and disinfection schedules shall be implemented and documented.

4.10.6 The intended use of cleaning utensils shall be clearly identified. Cleaning utensils
shall be used in a way to avoid contamination.
4.10.8 Cleaning chemicals shall be clearly labeled, used and stored appropriately, to
avoid contamination.
4.10.9 Cleaning activities shall be carried out in periods of non-production. If this is not
possible, these operations shall be controlled as to not affect the product.

4.11 Waste disposal

4.11.3 Packaging material waste and other waste shall be removed as quickly as
possible from areas where packaging material is handled. The accumulation of
waste shall be avoided.
4.11.4 Waste collection containers shall be clearly marked, suitably designed, in good
state of repair, easy to clean, and where necessary disinfected.
4.11.5 Waste collection rooms and containers (incl. compactors) shall be designed to
be kept clean to minimize pest attraction.
4.11.7 A system to control the disposal and / or destruction of trademark materials shall GAF: Continuity of disposal/destruction of trademark materials during
be in place. The system shall comply with legal requirements and customer crisis.
agreements, when is applicable. Trademark materials and its disposal shall be Examples of what should be asked:
included in the traceability system of the company – Who is responsible for waste disposal and/or destruction of trademark
materials (company/third-party service provider)?
– If absences of personnel occur (internal/external), what kind of measures
are taken by the company?
– How is the traceability of waste disposal and/or destruction for trademark
materials ensured?
4.12 Risk of foreign material, metal, broken glass and wood
4.12.1 KO no. 5: Based on hazard analysis and assessment of associated risks, GAF: Review of current hazard analysis and assessment of associated
KO procedures shall be in place to avoid contamination with foreign material. risk; changes on it due to possible increased risks in regard to the
Contaminated products shall be treated as non-conforming products. current crisis; continuity on implementation of controls defined.
Examples of what should be asked:
– Has hazard analysis and assessment of associated risk been reviewed
related to current pandemic issues?
– Have changes occurred based on the review?
– If new hazards/risks have been included: What kinds of foreign material
were identified and from what sources?; How does the company control
these new hazards/risks and how will contaminated products be handled?

4.12.2 In all areas, e.g. handling of raw materials, converting, wrapping and storage,
where hazard analysis and assessment of associated risks have identified the
potential for product contamination, the use of wood shall be excluded. Where
the use of wood cannot be avoided, the risk shall be controlled and the wood
shall be in good order and clean.

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4.12.3 Where metaland/or other foreign material detectors are required, they shall be
installed to ensure maximum efficiency of detection, in order to avoid subsequent
contamination. Detectors shall be subjected to regular maintenance to avoid
malfunction.
4.12.5 The appropriate accuracy of detectors shall be specified. Checks of proper
function of detectors shall be carried out regularly. In case of malfunction or
failure of a metal and/or foreign material detector, corrective actions shall be
defined, implemented and documented.
4.12.7 In all areas, e.g. handling of raw materials, converting, wrapping and storage,
where hazard analysis and assessment of associated risks have identified a
potential product contamination, the presence of glass and brittle material shall
be excluded. Where the presence of glass or brittle plastic cannot be avoided,
appropriate measures shall be in place to protect against breakage.

4.12.11 Based on hazard analysis and assessment of associated risks, preventive

measures shall be in place for handling of all kinds of containers in the
production process (turn over, blow, rinse, etc.).
4.12.12 Where visual inspection is used to detect foreign material, the employees shall GAF: Impact on the effectiveness of visual inspections.
be trained and operative change shall be performed at an appropriate frequency Examples of what should be asked:
to maximize effectiveness of process. – If absences of personnel occur in visual inspection controls, what kind of
measures are taken by the company?
– In case of replacements: are they trained?
– How is ensured the frequency of operative changes is maintained?
– How is the effectiveness measured?
NOTE: if no visual inspection is used to detect foreign material, the
requirement shall be rated with N/A.
4.13 Pest monitoring/Pest control
4.13.1 The company shall have a pest control system in place which is in compliance
with local legal requirements, taking into account, as a minimum:
– the factory environment (potential pests)
– site plan with area for application (bait map)
– identification of the baits on site
– responsibilities, in-house/external
– used products/agents and their instructions for use and safety
– the frequency of inspections. The pest control system shall be based on hazard
analysis and assessment of associated risks.

4.13.2 The company shall have qualified and trained in-house staff and/or employ the GAF: Continuity in pest monitoring activities and in the provision of
services of a qualified external provider. Where an external provider is used, the services when a third-party service provider is used.
activities required on site shall be specified in a written contract. Examples of what should be asked:
– Is a third-party service provider used to control/monitor pests?
– Has the company experienced absences in terms of external personnel?
– If absences of external personnel occur, what kind of measures are taken
by the third-party service provider and the company?
– Are there any access restrictions in place?
– Have the contracts been updated in relation to the health of external
personnel, access restrictions, or others measures applicable to the third-
party service provider (E.g. additional rules, training) in regard to the current
situation?
– Has system of monitoring been changed to internal personnel? If so, has
appropriate training been applied?

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4.13.3 Pest control inspections and resulting actions shall be documented. GAF: Continuity in pest monitoring activities and visits.
Implementation of actions shall be monitored and recorded. Examples of what should be asked:
– Has the crisis had an impact on pest control inspections? If the crisis has
had an impact on pest control inspections: what kind of measures has been
implemented by the company?. In regard to these new measures: Are the
responsibilities clearly defined, communicated and appropriate training has
been executed when applies?
NOTE: It must be assessed if during last weeks the current crisis has had an
impact on visits and monitoring activities.
4.13.4 Baits, traps and insect exterminators shall be functioning, shall be in sufficient
numbers and shall be placed in an appropriate position. They shall be
constructed and positioned as not to cause any contamination risk.

4.13.5 Incoming deliveries shall be checked on arrival for the presence of pests. Any
infestation shall be documented and control measures taken.
4.14 Receipt of goods and storage
4.14.1 All incoming goods, including wrapping materials, shall be checked for GAF: Impact of crisis in receipt of goods and its conformity.
conformity against specifications/other legally required documentation and to a Examples of what should be asked:
determined inspection plan. The inspection plan shall be risk based. Test results – Have any changes been done to inspection plan?
shall be documented. – Has the company identified additional inspection parameters as necessary
in the context of the current crisis (e.g. supply chain disruption, increased
susceptibility to fraud)?
– Has the company experienced any lacks in terms of personnel in charge to
check the conformity of incoming goods?
– What kind of measures has the company implemented in the receipt of
goods? (e.g., access restrictions in place, specific protocols to handle the
receipt of goods, specific rules regarding contact and health of external
personnel).
4.14.2 The storage conditions of raw materials, semi-processed and finished products
as well as wrapping shall in each case correspond to product requirements (e.g.
protective covers) and shall not be detrimental to other products.

4.14.3 Raw materials, packaging, semiprocessed and finished products shall be stored
so as to minimize the risk of cross contamination.
4.14.4 Appropriate storage facilities shall be available for the management and storage
of working materials, process aids, and additives. The personnel responsible for
the management of storage facilities shall be trained.
4.14.5 All products shall be clearly identified. Use of products shall be undertaken in
accordance with the principles of First In/First Out and/or First Expired/First Out.

4.15 Transport
4.15.1 Before loading transport vehicles, their condition (e.g. absence of strange smells,
high dust load, adverse humidity, pests, mould) shall be checked and action
taken, if necessary.
4.15.2 Procedures to prevent contamination during transport shall be implemented
(packaging material/nonpackaging material/different categories of goods).
4.15.5 Adequate hygienic requirements for all transport vehicles and equipment used
for loading/unloading (e.g. hoses of silo installations) shall exist. There shall be
records of the measures taken.
4.15.6 Loading and unloading areas shall have equipment in place to protect
transported products from external influences.
4.16 Maintenance and repair
4.16.5 Temporary repairs shall be carried out so that product requirements are not
affected. Such work shall be documented and a short-term deadline set for
eliminating the fault.
4.17 Equipment

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4.17.3 Equipment shall be designed and located so that cleaning and maintenance
operations can be effectively performed.
4.17.4 The company shall ensure that all product equipment is in good condition without
any negative influence on packaging material safety.
4.18 Traceability (including GMOs and allergens)
4.18.5 Traceability shall be ensured at all stages, including work in progress, post
treatment and rework.
4.19 Allergens and specific conditions of production
4.19.2 The manufacturing of products which contain allergens requiring declaration shall
be carried out as to ensure cross contamination is minimized as far as possible.

4.19.3 Where customers specifically require that products are “free from” certain
substances or ingredients (e.g. starch), or that certain methods of treatment or
production are excluded, verifiable procedures shall be in place.

5 Measurements, Analysis, Improvements

5.3 Process validation and control
5.3.2 In circumstances where the control of process and working environment
parameters (temperature, time, pressure, chemical properties etc.) is essential to
ensure the product requirements, such parameters shall be monitored and
recorded continuously and/or at appropriate intervals.
5.5 Control of quantity/filling quantity
5.5.3 Checks shall be implemented and recorded, according to a sampling plan which
ensures a proper representation of the manufacturing lot.
5.5.6 If applicable, all equipment used for final checking shall be approved.
5.10 Management of non-conformities and non conforming products
5.10.1 A procedure shall exist for the management of all non-conforming raw materials,
semi-finished and finished products, converting equipment and wrapping
materials. This shall include, as a minimum:
– isolation/quarantine procedures
– hazard analysis and assessment of associated risks
– identification (e.g. labeling)
– decision about the further use (e.g. release, rework/post treatment, blocking,
quarantine, rejection/disposal).
5.11 Corrective actions
5.11.2 Corrective actions shall be clearly formulated, documented and undertaken, as GAF: Review of corrective actions from previous IFS audit which can be
(MOD) soon as possible to avoid further occurrence of nonconformity. The verified on the documentary base.
responsibilities and the timescales for corrective action shall be clearly defined. Examples of what should be asked:
The documentation shall be securely stored, and easily accessible. – Which corrective actions were implemented?
The effectiveness of implemented corrective actions shall be checked. – Where are corrective actions documented?
– Has the effectiveness of corrective actions been checked?
– Have new corrective actions been taken since last IFS audit? If so, what
are the corrective actions taken regarding the coronavirus and its
direct/indirect impact?
6 Product defense plan and external inspections
6.3 Personnel & Visitor Security
6.3.1 Visitor policy shall contain aspects of product defense plan. Delivery and loading
staff in contact with the product shall be identified and shall respect the access
rules of the company. Visitors and external service providers shall be identified in
areas with product storage and shall be registered at the time of access. They
should be informed about the site policies and their access controlled
accordingly.

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