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GB 12693—2010

The person in charge of the food safety management institution shall be a legal corporate
representative or principal authorized by the legal entity.

All departments of the institution shall have definite management responsibilities, and
ensure the implementation of management responsibilities associated with quality and
safety. All departments shall effectively divide the work, and avoid overlapping,
repetition or omission of responsibilities. Corresponding management systems shall be
developed for internal and external factory environment, maintenance and management
of facilities and equipment in the plant. quality and safety management in production,
hygiene management, quality tracking, etc., and the person in charge of management and
responsibilities shall be determined.

All departments of the food safety management institution shall deploy full-time or part-
time food safety management personnel subject to professional training, publicize and
implement food safety regulations and relevant rules and regulations, be responsible for
supervising the implementation and properly make relevant records.

Record and document management
Record management

Corresponding record management system shall be developed to record the purchase.
production, storage, inspection, sales, etc. of raw materials and packing materials in the
processing of milk products in detail so as to increase the credibility and effectiveness of
the food safety management system.

The names, specifications, quantity, supplier name and contact, purchasing date. ete. of
food raw materials, food additives and food related products shall be faithfully recorded.
The processing of products (including process parameters, environment monitoring, etc.)

storage conditions of products, inspection batch No., inspection date, inspectors.
inspection methods, inspection results. etc. of products shall be faithfully recorded.

The names, specifications. quantity, manufacturing date. manufacturing batch No..
delivery places, name and contact of consignee. delivery date, etc. of delivery products
shall be faithfully recorded.

The names, batch No., specifications, quantity. causes for recall. subsequent rectification
plan, etc. of recalled foods shall be faithfully recorded.

All records shall be reviewed, signed or sealed by executive staff and relevant
supervisory staff, original records can not be crossed out so that the modified records can
not be recognized in case of any modifications to record contents, and the modifier shall
sign or seal near modified text after modification.

All production and quality management records shall be reviewed by relevant
departments to ensure that all procedures meet requirements, and any abnormalities shall
be immediately handled.

The retention period of relevant records stipulated by this Standard shall be not less than
two years,

Document management

Document management system shall be established, complete quality management
archive shall be built. and documents shall be filed and saved by categories. Distributed
and used documents shall be currently approved texts. Repealed or invalid documents
shall be unavailable at work site except for being kept for future reference.

Enterprises are encouraged to use advanced technologies (e.g. electronic computer
information system) for document and record management.
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GB 12693—2010

The quality of production water shall conform to provisions of GB 5749.
Drainage system

Appropriate drainage system shall be equipped, and products and production water shall
be protected from contamination during design and construction.

The drainage system shall be sloping. unblocked and easily cleaned, and the joint
between the side and bottom of drainage ditches shall be round-angled.5.3.2.3 Floor
drains with water seal shall be installed at the inlet of the drainage system to prevent
entry of solid wastes and escape of foul air.

Production water supply pipeline shall not be arranged in and below the drainage system.

The outlet of the drainage system shall be provided with devices to prevent intrusion of
animals,

Indoor drainage shall flow from areas with high cleanliness requirement to areas with low
cleanliness requirement, and there shall be design element of preventing reverse flow of
wastewater.

Wastewater shall be drained to waste water treatment system or treated in other
appropriate way.

Cleaning facilities

Appropriate facilities for cleaning food, tools and equipment and facilities for storing
wastes, etc. shall be provided.

Personal hygiene facilities
Personal hygiene facilities shall conform to provisions of GB 14881.

Disinfection facilities shall be provided before entering cleaning work area. and a second
dressing room shall be provided when necessary.

Ventilation facilities

Natural ventilation or artificial ventilation measures shall be taken to reduce air source
contamination and control peculiar smell. so as to ensure food safety and product
characteristics. The ambient temperature of cleaning work area shall be controlled in
production of milk powder, and air humidity shall be controlled when necessary.

Air conditioning facilities shall be installed in the cleaning work area to prevent steam
condensation and to keep indoor air fresh; ventilation facilities shall be installed in the
commonly work area to timely exhaust humid and foul air. When the factory buildings
involves air conditioning, air intake/exhaust or fans using, the air shall flow from areas
with high cleanliness requirement to areas with low cleanliness requirement to prevent
contamination of food, production equipment and inner packing materials.

Appropriate exhaust, collection or control devices shall be provided in areas where food
may be contaminated by foul smell and gas (steam and toxic harmful gas) or dust.

The air inlet shall be more than 2 m from the ground or roofing. away from
contamination sources and air outlet, and provided with air filter device. The air outlet
shall be provided with easily cleaned and corrosion-resistant mesh enclosure to prevent
intrusion of animals; and ventilation exhaust devices shall be easily removed for cleaning.
maintenance and replacement.

Compressed air or other gases used for food and clean food contact surfaces or equipment
shall be subject to filtration and purification treatment to prevent any indirect
contamination.

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GB 12693—2010

Enterprises shall establish supplier management system to stipulate the selection, review
and evaluation procedures for suppliers.

Enterprises shall establish purchasing inspection system for raw materials and packing
materials.

Enterprises using raw milk shall inspect purchased raw milk by batches according to
relevant food safety standards, faithfully record quality test situation, name and contact of
supplier, purchasing date, etc.. and check raw milk delivery receipt of transport vehicle.
Enterprises shall not purchase raw milk from units or individuals without raw milk
purchasing license.

At acceptance of other raw materials and packing materials, conformity certificates
(enterprise self-inspection report or inspection report issued by a third party) shall be
inspected; when valid conformity certificate is unavailable, the purchased raw materials
and packing materials shall be inspected according to corresponding food safety
standards or enterprise acceptance standards, and can be accepted and used only when
qualified. Relevant information of raw materials and packing materials shall be faithfully
recorded.

Raw materials and packing materials rejected shall be labeled, separately stored, and the
suppliers shall be informed for further treatment.

Any food safety problem found in raw materials and packing materials shall be reported
to the food safety supervision department to which the enterprise belongs.

Transport and storage requirements for raw materials and packing materials

Enterprises shall transport and store raw materials and packing materials according to
requirements ensuring quality safety.

Transport and storage of raw milk

Containers for transporting and storing raw milk shall conform to relevant national safety
standards.

Raw milk shall be cooled to 0 - 4 ‘C within 2 hours after milking. Raw milk shall be
transported in insulated milk tankers, and transport vehicles shall have complete
certificates and records.

Raw milk shall be timely processed after arriving at the factory. Otherwise in case of
untimely treatment, refrigerated storage facilities shall be provided and temperature and
relevant indexes shall be monitored and properly recorded.

Transport and storage of other raw materials and packing materials

Raw materials and packing materials shall be protected from direct solar radiation, rain,
violent changes in temperature and humidity, collision, etc. during transport and storage,
and shall not be packed or transported together with toxic and hazardous articles.

Raw materials and packing materials shall be protected from pollution and damage
during transport and storage, and measures shall be taken to minimize quality
deterioration; raw materials and packing materials having temperature, humidity and
other special requirements shall be transported and stored as required.

Raw materials and packing materials shall be stored by separate zones according to
different characteristics, and labeled to indicate relevant information and quality status
during storage.

Inventory raw materials and packing materials shall be regularly checked, and raw
materials and packing materials which are stored for a long time and may have change in.

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6.1.3
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GB 12693—2010
Design

All production equipment shall be designed and constructed for easy cleaning.
disinfection and inspection. Structures capable of preventing lubricating oil, metal debris,
sewage or other substances possibly resulting in contamination from mixing with food
shall be provided and conform to corresponding requirements.

Food contact surfaces shall be smooth and free of depression or crack to reduce
accumulation of food crumbs. dirt and organic matters.

Storage, transport and processing systems (including gravity, pneumatic, closed and
automatic systems) shall be designed and constructed for easy maintaining of their good
sanitary state. Material storage facilities shall be able to be sealed.

Special areas for storing spare parts of equipment shall be provided so that necessary
spare parts can be timely available during equipment maintenance, and storage areas for
spare parts shall be kept clean and dry.

Monitoring equipment

Monitoring equipment for measuring, control and record (such as pressure gauge and
thermometer) shall be regularly calibrated and maintained to ensure the accuracy and
effectiveness.

If a computer system and its network technologies are employed for collection of
monitoring data at critical control points and management of all records. refer to
provisions of Annex A of this Standard for relevant functions of the computer system and
its network technologies.

Maintenance and repair of equipment

Maintenance and repair procedures of equipment shall be developed and strictly
implemented.

Daily maintenance and service plan of equipment shall be developed for regular
maintenance, and record shall be properly kept.

Equipment shall be checked for normal state before each production to prevent the
circumstance affecting the sanitary quality of products: failure shall be promptly
eliminated, and time of failure, causes and possibly affected product batch shall be
recorded.

Hygiene management
Hygiene management system

Hygiene management system and assessment criteria shall be developed, and post
responsibility system shall be implemented.

Hygiene inspection plan shall be developed. and the implementation of the plan shall be
recorded and filed.

Hygiene management of the plant and facilities
All facilities in the plant shall be kept clean, timely maintained or updated: any damage in

roofs, ceilings and walls shall be immediately repaired, and the ground shall be free of
damage or accumulated water.

Equipment and tools for processing, packing, storage. transport, etc., production pipelines
and food contact surfaces shall be regularly cleaned and disinfected. Contamination to
food, food contact surfaces and inner packing materials shall be prevented during
cleaning and disinfection operations.

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GB_12693-2010bRYE (SEK) - PLE - BREE Page 11 of 25

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GB 12693—2010
Lighting facilities

Factory buildings shall have sufficient natural light or artificial light. the lighting
coefficient of workshops shall be not lower than standard Grade TV. Mixed illuminance
should be not lower than 540 Ix on the working face of quality monitoring site. not lower
than 220 Ix on the working face of processing site. and not lower than 110 Ix in other
places, excluding test areas sensitive to light. Food color under light sources must not
appear different from under natural light.

Lighting facilities shall be not installed right above exposed food: otherwise safety
lighting facilities shall be used to prevent contamination of food due to possible crack.

Warehousing facilities

The enterprise shall have warehousing facilities fitting to the varieties and quantity of its
milk products.

Storage places shall be separately arranged depending on different natures of raw
materials, semi-finished products. finished products, packing materials, etc. and cold
storages (refrigerators) shall be provided when necessary. When items of different
natures are stored in the same warehouse, the items shall be properly isolated (e.g. by
categories, racks or zones) and clearly labeled.

Warehouses shall be constructed with non-toxic and firm materials, have fat ground for
easy ventilation. and shall be provided with devices for preventing intrusion of animals
(for example, rat guards or ditches shall be arranged at the doors of warehouses).

Warehouses shall be provided with sufficient pallets (article storage racks), and an
appropriate distance shall be kept between articles and walls and the ground for
ventilation and articles handling.

Cold storages (refrigerators) shall be equipped with thermometers, temperature detectors
or automatic temperature recorders capable of correctly indicating indoor temperature of
warehouses and timely monitoring and recording temperature.

Equipment
Production equipment
General requirements

Production equipment adapted to the varieties and quantity of milk products in
production and operation shall be provided, and the capacity of all equipment shall match
mutually.

All production equipment shall be arranged in order according to process flow to avoid
cross contamination.

Operating regulations for special equipment (e.g. pressure vessels and pressure pipeline)
for use in production shall be developed.

Materials

All equipment and tools in direct or indirect contact with raw materials. semi-finished
products and finished products shall be made of safe materials that are non-toxic.
odorless, absorption-resistant, corrosion-resistant and capable of withstanding repeated
cleaning and disinfection.

Materials of product contact surfaces shall conform to relevant standards of food-related
products, and shall be smooth, easily cleaned and disinfected, waterproof and difficult to
peel off.

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GB_12693-2010hn7E (ESCM) - Puke - HAE Page 14 of 25

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GB 12693—2010

Insect control measures shall be developed to keep buildings in good condition and
environment clean, and prevent intrusion and breeding of insects.

Insect trapping lamps (traps) shall be arranged at entrances of production workshops and
storage sites. Window screens shall be provided or other measures shall be taken at places
in direct connection with external environment (e.g. windows) to prevent or get rid of
insects.

Factory environment and production sites shall be regularly monitored and checked for
insect signs, and if insects are found, insect source shall be found out to prevent
recurrence of similar situation.

Physical, chemical or biological preparations can be used, and the deinsectization method
shall neither affect food safety or product characteristics nor contaminate food contact
surfaces or packing materials (for example. the use of insecticides is avoided as far as
possible).

Waste disposal
Waste deposit and removal system shall be developed.

Containers for wastes, by-products and inedible substances or hazardous substances shall
have special labels and be reasonably constructed and waterproof. and can be closed
when necessary to prevent food contamination.

Temporary waste deposit facilities shall be arranged at appropriate plates, wastes shall be
classified for deposit according to their characteristics, and perishable wastes shall be
regularly removed.

Waste deposit places shall not have unpleasant odor or escape of hazardous and toxic gas,
and the breeding of insects shall be prevented so as to prevent from contaminating food,
food contact surfaces, water sources and the ground.

Management of toxic and hazardous substances
Relevant provisions of GB 14881 shall be followed.
Sewage and dirt management

Sewage discharge shall conform to requirements of GB 8978. and purification measures
shall be taken in case of inconformity, and sewage can be discharged only after
conforming to the standard.

Dirt management shall follow relevant provisions of GB 14881.
Working clothes management

Relevant provisions of GB 14881 shall be followed.
Requirements for raw materials and packing materials
General requirements

Enterprises shall establish management systems for purchase, acceptance, transport and
storage of raw materials and packing materials to ensure thal raw materials and packing
materials used meet requirements of laws and regulations. Any substances endangering
human health and life safety shall not be used.

Raw milk collection stations established by enterprises themselves shall conform to
relevant national and local regulations.

Purchase and acceptance requirements for raw materials and packing materials

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GB_12693-2010#RYE (GESChK) «- PkanHE - HAE Page 3 of 27

National Standard of the People's Republic of China

GB 12693—2010

National Food Safety Standard
Good Manufacturing Practice for Milk Products

Issued on 2010-03-26

” : __Implemented on 2010-12-01
Issued by Ministry of Health of the People’s Republic of China

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GB 12693—2010

Conforming detergents, disinfectants. insecticides and lubricating oil shall be selected
and used as required by product instfuctions: use record shall be made and properly
preserved to avoid food contamination.

Chemical substances shall be stored separately from food, clearly labeled, and kept by a
designated person.

Control of physical contamination

Measures such as equipment maintenance, hygiene management, site management,
visitor management and processing supervision shall be taken to protect products from
contamination of foreign substances (e.g. glass or metal debris and dust).

Effective measures (e.g. installation of screens, traps, magnets, electronic metal detectors)
shall be taken to prevent metal or other foreign materials from mixing into products.

Electric welding, cutting, grinding. etc. shall not be performed during production to
prevent the generation of peculiar odor and debris.

Food additives and nutritional fortification substances

Food additives and nutritional fortification substances shall be properly used in
conformity with the varieties. range and amount stipulated in food safety standards.

Food additives and nutritional fortification substances shall be accurately weighed and
properly recorded in their use.

Packing materials

Packing materials shall be clean and non-toxic, and conform to relevant national
regulations.

Packing materials and packing gas shall be non-toxic, and not affect food safety and
product characteristics in specific storage and use conditions.

Inner packing materials shall fully protect foods from contamination and prevent damage
in normal storage. transport and sales.

Reusable packing materials such as glass bottles and stainless steel containers shall be
thoroughly cleaned and subject to necessary disinfection before use.

Before packing operation. the label of packing materials to be put into use shall be
checked to avoid misuse of packing materials, and recorded. and the information shall
include product name, quantity. operators, time, etc. corresponding to packing materials.

Product information and labels

Product labels shall conform to GB 7718, national standards for corresponding products
and other relevant national regulations.

Inspection

Enterprises can perform self-inspection on raw materials and products, or entrust an
inspection agency with qualification for food inspection for inspection. Enterprises
performing self-inspection shall have corresponding inspection capability.

All batches of products shall be inspected according to relevant standards, and samples
shall be retained.

Quality management of laboratories shall be enhanced to ensure the accuracy and
authenticity of inspection results.

All inspection records and inspection report shall be completely kept.

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GB 12693—2010

quality shall be regularly sampled for quality confirmation; and deteriorated or expired
raw materials and packing materials shall be timely disposed of.

Qualified raw materials and packing materials shall be reasonably arranged for use
following the principle of “first in, first out” or “first expire, first out” 8.4 The
purchase, acceptance, storage and transport records of raw materials and packing
materials shall be kept.

Food safety control in production
Control of microbial contamination
Temperature and time

Methods for killing microbes or inhibiting their growth and reproduction, such as thermal
treatment, freezing or refrigerated storage, shall be stipulated according to product
characteristics and effective monitoring shall be implemented.

Temperature and time control measures and corrective actions shall be established, and
regular verification shall be performed.

Real-time monitoring measures shall be established for processing procedures in which
temperature and time are strictly controlled, and the monitoring records shall be kept.
Humidity

The air humidity shall be controlled where necessary according to product and process
characteristics to reduce the reproduction of harmful microbes: critical air humidity limits
shall be set and effectively implemented.

Real-time air humidity control and monitoring measures shall be established. regularly
verified and recorded.

Air cleanliness in production area

The air in production workshops shall be kept clean to prevent food contamination.

Aerobic bacterial count in the air of cleaning work area shall be controlled below 30
CFU/dish determined by natural settlement method of GB/T 18204.1.

Microbial contamination prevention

Necessary measures shall be taken for the whole process from arrival of raw materials
and packing mat s to the delivery of finished products to prevent microbial
contamination.9. 1.4.2 The operation, use and maintenance of equipment, containers
and tools for transporting, handling or storing raw materials, semi-finished products and
finished products shall avoid contamination to food in processing or storage.

Water for producing ice cubes and steam in direct contact with food during processing
shall conform to provisions of GB 5749.

Recycle water in evaporation or drying process of food processing and recycled water are
reusable, but shall have no harm to food safety and product characteristics, water
treatment shall be performed when necessary and effectively monitored.

Control of chemical contamination

Management system for preventing chemical contamination shall be established to
analyze possible contamination sources and ways, and control measures shall be
proposed.

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GB 12693-2010

Cleaned and disinfected portable equipment and tools shall be placed at appropriate
places capable of preventing food contact surfaces from recontamination, and kept in
usable state.

Cleaning and disinfection

Effective cleaning and disinfection plans and procedures shall be developed to ensure the
sanitation and hygiene of food processing places, equipment, facilities. etc so as to
prevent food contamination.

Cleaning and disinfection method can be selected according to characteristics of product
and process.

Equipment and tools used for cleaning and disinfection shall be stored properly at special
places.

Cleaning and disinfection procedures shall be recorded. such as varieties. acting time,
concentration, object and temperature of detergents and disinfectants.

Personal health and hygiene requirement

Personal health

Enterprises shall establish and implement health management system for employees.

Milk product processing personnel shall have health examination every year, and can
only take the job after obtaining health certificates.

Enterprises shall appoint personnel with infectious diseases of digestive tract (including
diarrhea. typhoid fever, viral hepatitis A and viral hepatitis E). personnel with active
tuberculosis, ulcerative or exudative dermatosis affecting food safety, and personnel with
unhealed wound to other posts not affecting food safety.

Personnel hygiene
Milk product processing personnel shall maintain good personal hygiene.

Milk product processing personnel shall put on neat working clothes, working hats and
working shoes (boots) before entering production workshops. The working clothes shall
cover outerwears, hair shall not be exposed outside hats, and masks shall be worn when
necessary. Personnel shall not enter toilets, leave production and processing sites or
operate across the region while wearing working clothes and working shoes (boots) for
cleaning work area and quasi-cleaning work area..

Hands have to be washed and disinfected before work, after going to toilet and after
contact with articles which may cause food contamination or other activities irrelevant to
production. Hands shall be kept clean during production, processing and operation.

Milk processing personnel shall not varnish nails, use perfume or wear watches or
decorations.

Smoking, eating or other activities affecting food hygiene are strictly prohibited at
workplaces.

Personal clothing shall be stored in personal lockers in the dressing room, and other
personal articles shall not be brought into production workshops.

Visitors

The visitors to food production, processing and operation places shall follow hygienic
requirements for operators at the site.

Insect control

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GB 12693—2010

Flat roofs or ceilings of workshops shall be constructed with non-toxic, odorless, white or
light colored waterproof materials, and in case of spraying coating, coatings that are
mould proof, difficult to peel off and easily cleaned coatings should be chosen.

Steam, water and electricity piping shall be not installed right above exposed food,
otherwise facilities capable of preventing falling of dust and condensation water shall be
installed.

Walls

Non-toxic, odorless, smooth, waterproof, easily cleaned and light colored anti-corrosion
materials shall be used for wall construction.

The corners and column corners of cleaning work area and quasi-cleaning area shall be
reasonably structured and easily cleaned and disinfected.

Doors and windows

Doors and windows shall be made of smooth and adsorption-resistant materials, and
easily cleaned and disinfected.

Doors and windows of production workshops and storage places shall be assembled
tightly, equipped with dustproof facilities that keep animals and insects out and easily
cleaned.

Doors that can close automatically (for example, equipped with automatic sensors or door
closers, etc.) and (or) air curtains shall be installed at the entrances/exits of cleaning work
area and quasi-cleaning work area.

Floors

Floors shall be constructed with non-toxic, odorless and waterproof materials, and be flat
and anti-slip without crack and easily cleaned and disinfected.

Floors involving drainage or wastewater flows during the work and floor areas where the
work environment is often wet or involves cleaning with water should be acid- and alkali-
resistant and be equipped with certain drainage slope and drainage system.

Facilities
Water supply facilities

Water supply facilities shall ensure that the quality, pressure, volume, etc. of water of
productive use are in line with production requirements.

Water supply equipment and tools shall be awarded with product hygienic licenses in
terms of health and safety of drinking water issued by health administrative agencies at or
above the provincial level.

The inlet and outlet of water supply facilities shall be additionally provided with safety
and health facilities to prevent food contamination due to entry of animals and other
substances.

Water supply facilities using secondary water supply shall conform to provisions of GB
17051,

Water supply process using self-contained water sources shall conform to relevant
hygienic requirements for centralized drinking water supply organizations issued by the
national health administration.

The piping system of non-drinking water not in contact with food (e.g. cooling water,
sewage or wastewater) shall be obviously distinguished and separated from the piping
system of production water, without reverse flow or interaction.

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GB 12693—2010

Annex A
(Informative)

Requirements for Application of Computer Systems of Milk Product and Infant

and Young Children Formula Food Manufacturers

The computer systems of milk product and infant and young children formula food manufacturers
shall meet regulatory requirements of Food Safery Law and relevant laws, regulations and standards
for food safety, form a complete information chain for tracing, tracking and locating food safety
problems in all procedures from the arrival of raw materials to the delivery of products, and submit
or remotely send relevant data as required by regulatory departments. The computer system shall
meet (but not limited to) the following requirements:

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A.7.2

The system shall include food safety related data acquisition and record keeping
functions of raw material purchase and acceptance, raw material storage and use.
monitoring of critical control procedures in production and processing, delivery
inspection, storage and transport of products, sales, etc.

The system shall be able to assess and early warn food safety risks of relevant raw
materials, processing techniques and products of the enterprise.

The system and supporting database shall establish and use a complete access control
mechanism to ensure compulsive use of staff account/password. and ensure that the
system and database have no bug allowing unauthorized access on the aspect of security
architecture.

Based on the access control mechanism, the system shall realize perfect security policy.
and set corresponding strategy group specific to different workers to determine that a
particular user or role can only has corresponding access. All data generated and engaged
by the system shall be saved in corresponding database, and shall not be saved as files to
determine that all data access shall be subject to access control of the system and database.

Special security strategy shall be employed for confidential information to ensure that
only the information owner has the access to read, write and delete. If confidential
information has to be stored and transferred beyond the safety control scope of the system
and database. the following requirements shall be met:

The confidential information shall be encrypted for storage to prevent unauthorized
persons from reading the information.

Check code shall be generated before transferring the confidential information, separately
transferred with the information (after encryption), and used for confirming that the
information is not falsified at the receiving terminal.

If the system needs to acquire data generated by aulomalic testing instruments, the system
shall provide a safe and reliable data interface. ensure the accuracy and high availability
of interface part, and guarantee that the data generated by instruments can be timely and
accurately acquired by the system.

Comprehensive and detailed system and database log management functions shall be
realized, including:

System log records user login information (user, time, IP login address. etc.) of the
system and database.

Operation log records data modification conditions (including modifier, modification
time, modified contents, original contents, etc.).

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GB 12693—2010
National Food Safety Standard

Good Manufacturing Practice for Milk Products
Scope

This Standard is applicable to manufacturers which proc rious milk products using
cow milk (or goat milk) and its processed products, etc. as main raw materials.

Normative references

Documents referenced in this Standard are indispensable for application of this Standard.
For dated references, only the dated edition is applicable to this Standard. For undated
references, the latest edition (including all amendments) referred to is applicable to this
Standard.

Terms and Definitions
Cleaning work area

Work areas with high cleanliness requirement. such as workshops for storage. filling and
inner packing of bare semi-products to be packed.

Quasi-cleaning work area

Work areas with cleanliness requirement lower than that of cleaning work area. such as
raw material preprocessing workshop.

Commonly work area

Work areas with cleanliness requirement lower than that of quasi-cleaning work area,

such as milk collecting workshop, raw material warehouse, packing material warehouse.
outer packing workshop and finished products warehouse.

Site selection and factory environment
Relevant provisions of GB 14881 shall be followed.
Factory buildings and workshops

Design and layout

All new, expansion and reconstruction projects shall be designed and constructed
according to relevant national provisions.

The layout of factory buildings and workshops shall be capable of preventing cross
contamination in processing of milk products, and avoiding contact with toxic substances
and unclean substances.

Appropriate separating measures shall be taken for the cleaning work area, quasi-cleaning
work area and commonly work area in workshops to prevent cross contamination.

Interior architectural structure
Roof

Indoor roofs and top corners of processing, packing and storage places shall be easily
cleaned to prevent dust accumulation and to avoid moisture condensation, signs of mould
or peeling off, etc. If the roofs of cleaning work area, quasi-cleaning work area and other
places where food are exposed (excluding milk collecting workshops) are of structures
easily hiding dirt, smooth and easily cleaned ceilings should be additionally provided:
while if the roofs are of reinforced concrete structures, the indoor roofs shall be flat and
seamless.

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GB 126923—2010

Foreword

This Standard replaces GB 12693-2003 Good Manufacturing Practice for Dairy Product Factory
and GB/T 21692-2008 Hygienic Practice for Dried Milk.

This Standard corresponds to CAC/RCP 1-1969, Rev.4-2003 Recommended International Code of
Practice General Principles of Food Hygiene and CAC/RCP 57-2004 Code of Hygienic Practice
for Milk and Milk Products of Codex Alimentarius Committee (CAC), and this Standard is not
equivalent to CAC/RCP 1-1969, Rev.4-2003 and CAC/RCP 57-2004. This Standard also refers to
(EC) No. 852/2004 On the Hygiene of Foodstuffs and (EC) No. 853/2004 Laying Down Specific
Hygiene Rules for Food of Animal Origin.

The main changes in this Standard over GB 12693-2003 and GB/T 21692-2008 are as follows:
-- modifying the name of this Standard to Good Manufacturing Practice for Milk Produc

-- adjusting the applicable scope, ahd emphasizing that this Standard is applicable to various
dairy enterprises:

++ modifying the provision framework of the Standard:

-- emphasizing the requirements for food safety control in raw material entry and production
process and contamination prevention in the whole manufacturing process of product
transport and storage:

-- adjusting the manufacturing equipment. and putting forward requirements for layout.
materials and design on the manufacturing equipment in terms of preventing microbial,
chemical and physical contamination:

-- canceling hardware requirements in laboratory construction:
-- adding relevant requirements for purchase. acceptance, transport and storage of raw materials:

-- emphasizing food safety control of manufacturing process, and developing major measures
for controlling microbial, chemical and physical contamination;

-- adding requirements for packaging materials and their use:

-- adding control targets and monitoring and recording requirements of critical control points:
-- adding specific requirements for product tracing and recall: and

-- adding requirements for management of records and documents.

Annex A of this Standard is informative.

The previous editions replaced by this Standard are as follows:

- GB 12693-1990, GB 12693-2003; and

--  GB/T 21692-2008.

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GB 12693—2010

11 Storage and transport of products

Lbal Storage and transport methods shall be selected according to the categories and natures of
products, and conform to storage conditions marked on product labels.

11.2 Products shall be protected from direct sunlight, rain, violent changes in temperature and
humidity, collision, etc. during storage and transport to prevent adverse effect on
ingredients, quality, etc. of milk products: and products shall not be stored and
transported together with odorous, toxic or hazardous articles.

11.3 Containers, tools and equipment for storage, transport and handling shall be clean, safe
and in good state to prevent product contamination,

11.4 Products in warehouses shall be regularly checked and temperature and (or) humidity
records shall be kept when necessary. and any abnormalities shall be timely handled.

ILS The quality status of inspected products shall be marked.

11.6 Records on storage, transport and delivery of products shall be kept so as to the products
can be quickly recalled in case of finding problems.

12 Product tracing and recall

ea Product tracing system shall be established to ensure effective tracing of products in all

procedures from purchase of raw materials to sales of products.

lez Product recall system shall be established. When a batch or category of products contain
or may contain factors causing harm to consumer's health, product recall procedures shall
be initiated according to relevant national regulations, and the situation shall be timely
reported to relevant departments and properly recorded.

133 Recalled foods shall be subject to harmless treatment, destruction, etc., and food recall
and handling conditions shall be reported to relevant departments.

12.4 Customer complaint handling mechanism shall be established. Relevant management
departments of an enterprise shall record written or oral opinions and complaints of
customers, find out causes and properly handle such complaints.

13 Training

13.1 Training system shall be established for food safety knowledge training of all employees
of the enterprise.

13.2 Annual training plan shall be developed according to different needs of posts for
corresponding training, and personnel for special types of work shall have certificates.

13.3 The training plan shall be regularly reviewed and revised. training effects shall be
assessed and routine inspection shall be performed to ensure effective implementation of
the plan.

13.4 Training records shall be kept.

14 Management institution and personnel

14.1 A sound food safety management system of the organization shall be established,
corresponding management measures shall be taken, and safety and quality control shall |
be performed on milk product production in the whole process from the arrival of raw |
materials and the delivery of finished products to ensure that the products meet |
requirements of laws, regulations and relevant standards.

14.2 Food ‘safety management institution shall be established to take charge of food safety
management of the enterprise.

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GB 12693—2010

A713 There shall be retention policy for system log and operation log. any users (excluding
system administrator) can not delete or modify within the time limit so as to ensure the
traceability at certain time.

AS A detailed use and management system for the system shall be developed. which at least
shall include the following contents:

A8.1 A real-time recording system for original data, intermediate data, generated data and
processing flow in the work flow, which ensures that the whole work process can be
reproduced.

A8.2 A detailed backup management system, which ensures that the whole system and
corresponding data can be restored completely and quickly after faults and disasters.

A8.3 The machine room shall be equipped with intelligent uninterrupted power supply (UPS)
which shall be connected with the work system to ensure that the UPS can supply power
and inform the work system of data storage and log operation in case of external power
failure (the UPS shall be able to provide power for ensuring emergency saving operation
of the system).

A8.4 A complete data access management system shall be established, confidential data is
strictly prohibited to be saved on shareable devices; and data sharing in the department
shall also subject to the access control system to realize authorized access.

ABS A supporting system maintenance system, including regular storage reorganization and
system detection, which ensures long-term and stable operation of the system.

A8.6 A safety management system, which requires regular change of user passwords at all
parts of the system so as to restrict the login sites of some users, and timely delete
unwanted accounts.

A8.7 Tt shall be stipulated that users logging from external network shall not start and use
user/password memory functions provided by the operating systems of external
computers so as to prevent information theft.

Ad When real-time monitoring data of critical control points is inconsistent with the set
standard value, the system shall be capable of recording the date and batch No. of
deviation. specific method for correcting deviation, name of operator. etc.

ALO Data and relevant records of the system shall be capable of being reproduced for
inspection and analysis by regulatory departments.

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