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Standard ID | GB 23790-2023 (GB23790-2023) | Description (Translated English) | (Market, Public Opinion and Social Survey Survey Report Preparation Guide) | Sector / Industry | National Standard | Date of Implementation | 2023-11-27 | Standard ID | GB 23790-2010 (GB23790-2010) | Description (Translated English) | National food safety standard - Good manufacturing practice for powdered formulae for infants and young children | Sector / Industry | National Standard | Classification of Chinese Standard | X82;C53 | Classification of International Standard | 67.100.10 | Word Count Estimation | 11,169 | Date of Issue | 2010-03-26 | Date of Implementation | 2010-12-01 | Older Standard (superseded by this standard) | GB/T 23790-2009 | Quoted Standard | GB 12693; GB/T 18204.1; GB 5749; GB 13432 | Regulation (derived from) | Circular of the Ministry of Health (2010)7 | Issuing agency(ies) | Ministry of Health of People's Republic of China | Summary | This Chinese standard applies to milk or soy and its processed products as the main raw material of powdered infant formula (including powdered infant formula, powdered formula foods for older infants and young children) of production enterprises. | Standard ID | GB/T 23790-2009 (GB/T23790-2009) | Description (Translated English) | Good manufacturing practice for infant formula factory | Sector / Industry | National Standard (Recommended) | Classification of Chinese Standard | X82 | Classification of International Standard | 67.040 | Word Count Estimation | 20,222 | Date of Issue | 2009-05-18 | Date of Implementation | 2009-12-01 | Drafting Organization | Chinese Institute of Food and Fermentation Industry | Administrative Organization | National Technical Committee of Standardization for special dietary | Regulation (derived from) | National Standard Approval Announcement 2009 No.6 (Total No.146); National Standard Approval Announcement 2010 No.5 (Total No.160) | Proposing organization | National Standardization Technical Committee special dietary | Issuing agency(ies) | Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China | Summary | This standard specifies the infant formula manufacturers purchase of raw materials, product processing, packaging and storage and other processes. And health, production process, product quality and other management conditions and requirements to be met. In order to ensure safe, reliable, healthy products. This standard applies to infant formula companies. |
GB 23790-2023
GB
NATIONAL STANDARD OF THE
PEOPLE'S REPUBLIC OF CHINA
National food safety standard - Good manufacturing
practice for formulae for infants and young children
ISSUED ON: SEPTEMBER 6, 2023
IMPLEMENTED ON: SEPTEMBER 6, 2024
Issued by: National Health Commission of the People's Republic of China;
State Administration for Market Regulation.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Terms and definitions ... 4
3 Site selection and factory environment ... 5
4 Factory buildings and workshops ... 5
5 Facilities and equipment ... 9
6 Health management ... 11
7 Food raw materials, food additives, and food-related products ... 13
8 Food safety control during production ... 13
9 Inspection ... 18
10 Storage and transportation of food ... 18
11 Product recall management ... 18
12 Training ... 18
13 Management system and personnel ... 19
14 Record and document management ... 19
Appendix A Guidelines for environmental monitoring of Salmonella, Cronobacter spp.
(Enterobacter sakazakii) and other Enterobacteriaceae in cleaning work areas of
powdered infant and young child formula foods ... 20
National food safety standard - Good manufacturing
practice for formulae for infants and young children
1 Scope
This standard specifies the basic requirements and management guidelines for sites,
facilities, and personnel in the production process of formula foods for infants and
young children such as raw material procurement, processing, packaging, storage, and
transportation.
This standard applies to the production of formula foods for infants and young children
with milk and/or soybeans and their processed products as the main protein source.
2 Terms and definitions
The terms and definitions defined in GB 14881, GB 10765, GB 10766, and GB 10767
apply to this standard.
2.1 Wet (production) process
The production process of processing the ingredients of powdered infant and young
child formula foods in a liquid state into the final product. This process usually includes
batching, heat treatment, concentration, drying, packaging (filling), and other processes.
2.2 Dry (production) process
The production process of physically mixing the ingredients of powdered infant and
young child formula foods in a solid state to produce the final product. This process
usually includes batching, mixing (including premixing), packaging (filling), and other
processes.
2.3 Dry-wet combined (production) process
A complete production process in which part of the ingredients of powdered infant and
young child formula foods are processed in a liquid state, dried, and then another part
of the solid ingredients is added by using a dry process, and then packaged (filled) to
make the final product.
2.4 Liquid (production) process
The production process of processing the ingredients of infant and young child formula
food in a liquid state into the final liquid product. This process usually includes batching,
homogenization, sterilization, filling, sealing, and other processes (also includes
sterilization process after filling and sealing).
3 Site selection and factory environment
3.1 It shall comply with the relevant provisions of GB 14881.
3.2 It shall be kept away from livestock and poultry farms, and animals shall not be
raised in the factory area.
4 Factory buildings and workshops
4.1 Basic requirements
They shall comply with the relevant provisions of GB 14881.
4.2 Design and layout
4.2.1 Factory buildings and workshops shall be reasonably designed, planned, and
constructed to be compatible with facilities and equipment to prevent microbial
contamination and growth, especially contamination by Salmonella and Cronobacter
spp. (Enterobacter sakazakii). The following shall be considered in the design:
a) Wet areas and dry areas shall be effectively separated; contamination caused
by personnel, equipment, facilities, and material flow shall be effectively
controlled to prevent microorganisms that are easily harmful to infants and
young children from entering the cleaning work area, such as Salmonella,
Cronobacter spp. (Enterobacter sakazakii).
b) The cleaning work area shall prevent the generation of condensation water.
c) The wet cleaning process shall be reasonably designed, and improper wet
cleaning shall be prevented in dry areas.
d) All kinds of pipes, cables, and penetration gaps that pass through the floor,
ceiling, and wall of the building shall be enclosed or sealed.
4.2.2 Reasonable zoning shall be carried out according to the product characteristics,
production technology, and the requirements for cleanliness of the production process,
combined with the actual conditions of the factory building and workshop. Generally,
the factory building and workshop are divided into common work areas, quasi-cleaning
work areas, and cleaning work areas.
a) The common work areas include the milk collection room, raw material
warehouse, packaging material warehouse, outer packaging workshop and
finished product warehouse, sterilization area for the sterilizing-after-filling
liquid products after filling and sealing, etc.
b) The quasi-cleaning work areas include raw material pretreatment workshops,
raw material inner packaging cleaning or packaging material disinfection or
tunnel sterilization areas, wet processing areas for powdered products (such as
weighing, batching, and concentration), areas for weighing, batching, heat
treatment, disinfection or sterilization of liquid products, filling area for the
sterilizing-after-filling liquid products, etc.
c) The cleaning work areas include workshops where food is in contact with the
air environment and there are no subsequent disinfection or sterilization
operations (such as weighing, batching, and mixing), filling areas for liquid
aseptic filling products, and auxiliary areas with special cleaning requirements
(such as temporary storage rooms for temporarily storing cleaned and
disinfected inner packaging), storage areas for exposed semi-finished products
to be packaged, filling and inner packaging workshops, etc.
4.2.3 Effective separation shall be set up between working areas with different
cleanliness levels. An independent air purification system with a filter device shall be
installed in the cleaning work area and positive pressure shall be maintained to prevent
unpurified air from entering the cleaning work area and causing cross-contamination.
4.2.4 Reasonable and effective control measures shall be taken when entering and
exiting the cleaning work area to avoid or reduce microbial and other contamination.
For personnel, raw materials, packaging materials, waste, equipment, etc. that enter and
exit the cleaning work area, measures shall be taken to prevent cross-contamination,
such as setting up changing rooms for personnel to change work clothes, work shoes or
shoe covers, dedicated logistics channels, and waste sealing protection. For materials
transported through pipelines by using airflow as a carrier to enter the cleaning work
area, an appropriate air filtration system shall be designed and installed for the carrier
airflow.
4.2.5 The dynamic control requirements for the cleaning work area in the production of
powdered infant and young child formula foods shall comply with the provisions in
Table 1. The dynamic control requirements for the cleaning work area in the production
of liquid infant and young child formula foods shall comply with the provisions in Table
2, and the inspection shall be carried out regularly. The number of settling microbes in
the air in the quasi-cleaning work area shall be ≤50 CFU/dish (measured according to
GB/T 16294 for 5 minutes) and shall be monitored and recorded.
4.2.7 Factory buildings, workshops, and warehouses shall have facilities to prevent pest
intrusion.
5 Facilities and equipment
5.1 Basic requirements
They shall comply with the relevant provisions of GB 14881.
5.2 Drainage facilities
5.2.1 In the cleaning work area where powdered infant and young child formula foods
are produced, drainage facilities shall be avoided. If necessary, appropriate measures
shall be taken to keep the drainage facilities in a dry state during production.
5.2.2 Drainage facilities shall have a slope, be kept smooth, and be easy to clean. There
shall be no dead corners for cleaning at the joints between the sides and bottom of the
drainage ditch, or corresponding measures shall be taken to prevent the generation of
water accumulation. Drainage facilities in the work area shall avoid sewage backflow
and turbid gas escape, and hygienic clean floor drains shall be used when necessary.
5.2.3 There shall be no water supply pipelines for production water in and below the
drainage facilities.
5.3 Personal hygiene facilities
5.3.1 The changing rooms (including for changing shoes or wearing shoe covers), hand
washing and hand drying facilities, and disinfection facilities shall be set up near the
entrance of the production site or production workshop.
5.3.2 Necessary cleaning measures shall be taken before personnel enter the cleaning
work area, and a dedicated changing room shall be set up at the entrance of the
personnel. Hand disinfection facilities shall be set up at the entrance of the cleaning
work area, but hand washing facilities do not need to be set up.
5.4 Ventilation facilities
5.4.1 The temperature and humidity of the clean working area where powdered infant
and young child formula foods are produced shall be adjustable, and a monitoring
device shall be installed.
5.4.2 Effective measures shall be taken for outdoor air inlets to prevent animals or other
foreign objects from entering, such as being more than 2 m away from the ground or
roof, and setting up fences. They shall be far away from pollution sources and exhaust
outlets, and shall be equipped with air filtering equipment. The exhaust outlet shall be
equipped with an easy-to-clean, corrosion-resistant mesh cover to prevent animal
intrusion.
5.4.3 Compressed air or other gases used for food production and cleaning food contact
surfaces and equipment shall be filtered and purified to prevent indirect pollution.
5.4.4 In areas where odors, gases (steam and harmful gases), or dust are generated that
may contaminate food, there shall be appropriate elimination, collection, or control
devices.
5.4.5 A purification air-conditioning system shall be installed in the cleaning work area
to prevent steam condensation and keep the indoor air fresh; ventilation facilities shall
be installed in the common work area or ensure good ventilation to remove moist and
dirty air in a timely manner. When air conditioning, air intake and exhaust, or fans are
used in the factory building, the air shall flow from areas with high cleanliness
requirements to areas with low cleanliness requirements to prevent food, production
equipment, and inner packaging materials from being contaminated.
5.4.6 The ventilation facilities of the production area and the inspection room shall be
kept independent of each other. The exhaust outlet of the ventilation facilities in the
inspection room shall not pollute the fresh air supplementary inlet in the production
area.
5.5 Equipment
5.5.1 Production equipment shall have obvious operating status signs to indicate its
status of normal, repair, out-of-use, limited, etc., and shall be repaired and maintained
regularly. Equipment installation, repair, and maintenance operations shall not affect
the quality of the product. It shall be ensured that the performance of the repaired
equipment meets the process requirements and it shall be verified if necessary.
Equipment that is out of service for any reason shall be cleaned and protected, and
clearly marked. Equipment operating status identification should be displayed by an
automated control system or manually identified.
5.5.2 Compressed air or other inert gases used for food and food contact surfaces shall
be filtered and purified at least to remove oil, water, bacteria, dust, etc. before use
(outsourced qualified products that meet production requirements can be used directly).
5.5.3 The inner walls and welds of equipment in contact with materials shall be smooth,
flat, without dead corners, easy to clean, and corrosion-resistant. The inner surface shall
be made of materials that do not react with materials, release particles, or absorb
materials. They shall not cause stagnation or accumulation of materials.
5.5.4 For the production of powdered and liquid infant and young child formula foods,
after the sterilization equipment is installed, the sterilization effect of the materials shall
equipment and processing environment, and wet cleaning shall be avoided as much as
possible. Wet cleaning shall be limited to equipment parts that can be moved to a
dedicated room or the situation that drying measures can be taken immediately after
wet cleaning.
6.2.2 The following measures shall be taken for cleaning work areas that need to be
kept dry:
a) Adopt a dry-cleaning process suitable for the place and equipment. When
using a disinfectant containing necessary moisture, it shall be able to ensure
that the cleaning work surface is dry, or dry cleaning shall be carried out in a
dry state without using disinfectants;
b) When using wet cleaning measures under controlled conditions, it shall be
ensured that the equipment and environment can be restored to dryness in a
timely and thorough manner so that the area is not contaminated;
c) Mixing cleaning tools in different work areas shall be avoided.
6.2.3 Effective supervision measures shall be developed to ensure that key processes
such as manual cleaning, cleaning in place operations (CIP), and equipment
maintenance comply with relevant regulations and standard requirements, especially to
ensure the applicability of cleaning and disinfection plans, the type and concentration
of cleaning agents and disinfectants are appropriate, and the CIP system meets the
relevant temperature and time requirements.
6.2.4 A cleaning and disinfection plan shall be formulated for the cleaning work area to
ensure that all zones of the cleaning work area are cleaned. A cleaning or disinfection
plan shall be developed for quasi-cleaning work areas and common work areas based
on needs to prevent cross-contamination.
6.2.5 Cleaning and disinfection records shall be kept.
6.3 Work clothes management
Employees in the cleaning work area shall wear work clothes (or disposable work
clothes) that meet the hygiene requirements of the area, and be equipped with hats,
masks, and work shoes. Employees in quasi-clean work areas and common work areas
shall wear work clothes that meet the hygiene requirements of the corresponding areas,
and be equipped with hats and work shoes. Work clothes (including hats and masks)
and work shoes used in cleaning work areas and quasi-cleaning work areas shall not be
worn outside designated areas.
7 Food raw materials, food additives, and food-related products
7.1 They shall comply with the relevant provisions of GB 14881.
7.2 The food raw materials and food additives used shall comply with the requirements
of corresponding national standards and/or relevant regulations, and shall ensure the
safety of infants and young children and meet their nutritional needs. The supplier
management, transportation, storage, procurement, and acceptance of raw milk shall
comply with the relevant requirements of GB 12693.
7.3 For raw materials and food additives that directly enter the dry mixing process,
measures shall be taken to ensure that the microbial indicators meet the requirements
of product standards. For raw materials containing soybeans or soy protein components,
the urease activity shall be ensured to be negative.
7.4 Suppliers shall be evaluated, and if necessary, on-site reviews shall be conducted or
the production process shall be monitored.
7.5 Food additives shall be strictly managed, special warehouses or storage areas shall
be set up, clearly marked to avoid cross-contamination and misuse, and a special
register (or warehouse management software) shall be used to record the food additive’s
name, manufacturer or supplier, production date or production batch number, purchase
date, purchase quantity, and usage, etc.
7.6 The food raw materials, food additives, and packaging materials in stock shall be
inspected regularly. For food raw materials, food additives, and packaging materials
that have been stored for a long time or whose quality is prone to change, the quality
and safety management shall be strengthened and samples shall be taken to confirm the
quality before use; for nutritional supplements such as vitamins whose quality is prone
to change during the storage period, the shelf life management and storage environment
requirements shall be established, and inspections shall be conducted when necessary
to ensure that they meet the requirements; food raw materials, food additives and
packaging materials that have deteriorated or exceeded their shelf life shall be cleaned
up in a timely manner.
7.7 When automated warehouses are used to store food raw materials and food additives,
effective control measures shall be established for the reliability of the automation
system.
8 Food safety control during production
8.1 Basic requirements
8.1.1 They shall comply with the relevant provisions of GB 14881.
8.1.2 The relevant principles of hazard analysis and critical control points shall be
followed to establish and effectively operate a strict food safety control system.
8.1.3 When different types of products are produced on the same production line, the
site shall be cleared and records of clearance shall be kept when switching between
different products to ensure that product switching does not affect the next batch of
products.
8.2 Special requirements for the production process of powdered infant and young
child formula foods
8.2.1 Heat treatment (wet and dry-wet combined production processes)
8.2.1.1 The heat treatment process shall be regarded as a key control point to ensure the
safety of powdered infant and young child formula foods. The heat treatment
temperature and time shall consider the impact of factors such as product attributes
(including fat content, total solid content, etc.) on the heat resistance of the sterilization
target microorganisms, and monitoring measures that can reflect the heat treatment
temperature, time and related key factors that affect the heat treatment effect shall be
formulated to ensure that there is no deviation from the process parameter limit
requirements; if there is a deviation, appropriate corrective measures shall be taken for
real-time monitoring, and corresponding monitoring records shall be retained.
8.2.1.2 If the raw materials containing soybeans or soy protein components are used
and have not been heated to inactivate the enzyme (or the enzyme is not completely
inactivated), the heat treatment shall be used to simultaneously kill pathogenic bacteria
and completely eliminate the enzyme (urease activity is negative), and it shall be
monitored.
8.2.1.3 Key process parameters such as time, temperature, and enzyme inactivation time
during heat treatment shall be recorded.
8.2.2 Intermediate storage
8.2.2.1 In wet and dry-wet combined processes, corresponding measures shall be taken
for the intermediate storage of liquid semi-finished products to prevent the growth of
microorganisms.
8.2.2.2 If exposed raw material powder in dry production or powdery semi-finished
products exposed in wet production need to be temporarily stored, it shall be done in a
cleaning work area.
8.2.2.3 If powdery semi-finished products are placed outside the clean area, measures
shall be taken to ensure that the requirements of the cleaning work area are met when
they enter the clean area. At the same time, the storage period and storage conditions of
powdery semi-finished products shall be specified, and the quality of semi-finished
screens, strong magnets, and metal detectors, to prevent and inspect foreign matter, and
process monitoring and effectiveness verification shall be implemented.
8.2.7 Environmental monitoring requirements
Environmental monitoring measures shall be established for Salmonella, Cronobacter
spp. (Enterobacter sakazakii) and other Enterobacteriaceae in the cleaning work area of
powdered infant and young child formula foods, and the monitoring requirements shall
comply with the requirements of Appendix A.
8.3 Special requirements for the production process of liquid infant and young
child formula foods
8.3.1 Product technology
8.3.1.1 All process operations shall meet the process requirements, and the process
method of heat sterilization and aseptic filling or final heat sterilization after sealing
shall be selected to achieve the purpose of commercial sterility.
8.3.1.2 After batching, all material delivery pipelines and equipment shall be kept
closed.
8.3.1.3 Control measures shall be formulated to prevent foreign matter from entering
the product during the production process.
8.3.2 Washing, sterilization, and clean-keeping of packaging containers
8.3.2.1 Food containers, packaging materials, detergents, and disinfectants that comply
with national food safety standards and are approved by the health administrative
department shall be used.
8.3.2.2 Packaging materials, containers, and equipment after final cleaning shall be
handled to avoid recontamination.
8.3.2.3 Packaging materials used in aseptic filling systems shall be sterilized by
appropriate methods, and shall be cleaned and dried when necessary. After sterilization,
they shall be placed in a cleaning work area for cooling before use. If the storage time
exceeds the specified period, they shall be re-sterilized.
8.3.3 Washing, sterilizing, and clean-keeping of product processing equipment for
aseptic filling processes
8.3.3.1 Before production, high-temperature pressurized water, filtered steam, sterile
distilled water, or other suitable treatment agents shall be used to clean and sterilize the
high-temperature holding sterilization position for the product, all pipelines, valves,
pumps, buffer tanks, and filling equipment downstream of the pipeline, and other
product contact surfaces. It shall be ensured that after product sterilization, all
equipment surfaces that are in direct contact with the product meet the requirements for
aseptic filling and remain in this state until the end of production.
8.3.3.2 The aseptic warehouse of the filling and packaging equipment shall be cleaned
and sterilized, meet the requirements of aseptic filling before the product is filled, and
remain in this state until the end of production. When sterilization fails or the aseptic
state fails, the sterile warehouse shall be re-sterilized. During sterilization, key
indicators such as time, temperature, and disinfectant concentration shall be monitored
and recorded.
8.3.4 Filling of products
8.3.4.1 Automatic mechanical devices shall be used for product filling, and manual
operation is not allowed.
8.3.4.2 For products that require sterilization after filling, the time from filling to
sterilization shall be controlled within the time limit required by the process regulations.
The monitoring standards of microbial contamination levels of the product before
sterilization shall be determined based on the effect of the sterilization method used and
monitored regularly.
8.3.5 Sterilization of products
8.3.5.1 A suitable sterilization process needs to be established based on the heating
characteristics of the product and the death kinetics of specific target microorganisms.
The product is heated to sterilization temperature and shall be maintained at that
temperature for a certain period of time to ensure commercial sterility. All sterilization
processes shall be verified to ensure process reproducibility and reliability.
8.3.5.2 For liquid products that are sterilized after filling, the loading method of the
products and items to be sterilized in the chamber of the sterilization equipment shall
be confirmed through verification. The time-temperature curve of the sterilization
process shall be recorded for each sterilization. There shall be a clear method of
distinguishing between sterilized products and products to be sterilized. Sterilization
records shall be used as one of the bases for the release of this batch of products.
8.3.5.3 Commercial sterility testing shall be conducted on the product to determine
whether it meets commercial sterility requirements. Once a deviation is found during
the sterilization process, the deviation shall be corrected according to the correction
plan, the product shall be isolated, the cause shall be identified, and corrective measures
shall be proposed. If it is determined that the batch of products does not meet
commercial sterility requirements, it shall be properly handled under strict supervision.
The determination process, results, and processing methods shall be recorded in detail.
......
GB 23790-2010
GB
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
National Food Safety Standard
Good Manufacturing Practice for Powdered Formulae for
Infants and Young Children
ISSUED ON. MARCH 26, 2010
IMPLEMENTED ON. DECEMBER 1, 2010
Issued by. Ministry of Health of the People’s Republic of China
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and Definitions ... 4
4 Site selection and factory environment... 5
5 Plant and workshop... 5
6 Equipment ... 7
7 Hygiene management ... 8
8 Requirements for raw materials and packing materials ... 9
9 Food safety control in production ... 10
10 Inspection ... 13
11 Storage and transport of products ... 13
12 Product tracing and recall ... 13
13 Training ... 13
14 Management institution and personnel ... 13
15 Record and document management ... 13
16 Monitoring and evaluation of effectiveness of food safety control measures ... 13
Annex A ... 14
Foreword
This Standard replaces GB/T 23790-2009 Good Manufacturing Practice for Infant formula Factory.
This Standard refers to international standard CAC/RCP 66-2008 Code of Hygienic Practice for
Powdered Formulae for Infants and Young Children.
Compared with GB/T 23790-2009, the main changes in this Standard are as follows.
-- Change the name of this Standard into Good Manufacturing Practice for Powdered
Formulae for Infants and Young Children.
-- Change voluntary standard to mandatory standard;
-- Modify the provision framework of this Standard;
-- Add relevant requirements for raw material purchase, acceptance, transport and storage;
-- Modify the food safety control measures for manufacturing process. Add specific treatment
procedures for safety control. Formulate the control requirements for important procedures
such as heat treatment, intermediate storage, cooling, dry mixing and inner packaging. Refer
to provisions of GB 12693-2010 for critical control measures for microbial, chemical and
physical contamination;
-- Add the requirements for safety control of raw material soybean;
-- Add the monitoring and evaluation method for effectiveness of food safety control measures;
and
-- Add Annex A. Specify the requirements for monitoring main contamination sources in the
environment of cleaning work area – salmonella, enterobacter sakazakii and other
enterobacteriaece.
Annex A of this Standard is normative.
The previous edition replaced by this Standard is as follows.
-- GB/T 23790-2009.
National Food Safety Standard
Good Manufacturing Practice for Powdered Formulae for Infants and
Young Children
1 Scope
This Standard is applicable to manufacturers of powdered formulae for infants and young
children (including powdered formulae for infants, powdered formulae for older infants
and young children) with milk or soybean and its processed products as main materials.
2 Normative references
Documents referenced in this Standard are essential 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) is applicable to this Standard.
3 Terms and Definitions
3.1 Cleaning work area
The work areas with high cleanliness requirement, such as workshops for storage, filling
and inner packing of bare semi-products to be packed.
3.2 Quasi-cleaning work area
The work areas with cleanliness requirement lower than that of cleaning work area, such
as raw material preprocessing workshop.
3.3 Commonly work area
The 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.
3.4 Wet-mix process
The production process that processes and mixes the ingredients of powdered formulae
for infants and young children in liquid state. It usually includes blending, heat treatment,
concentration, drying and other procedures.
3.5 Dry-mix process
The production process that processes and mixes the ingredients of powdered formulae
for infants and young children in dry state to make finished products.
3.6 Combined process
reasonable sampling frequency, including collecting the occurrence of salmonella or
enterobacter sakazakii for a long time.
The frequency of implementing the monitoring plan shall be adjusted according to the
detection results and degree of contamination risk. When the quantity of pathogenic
bacteria or indicator bacteria is detected in finished product increases, environmental
sampling and survey sampling shall be enhanced to determine the contamination sources.
When the risk of contamination increases (e.g. after maintenance, construction or wet
cleaning), the sampling frequency shall be increased properly.
A.2.6 Sampling tools and methods
The sampling tools and methods shall be chosen according to surface type and sampling
location. For example, scraping the residue on the surface or powder in vacuum cleaner
as samples directly. For bigger surface, wiping and sampling by sponge (or cotton swab)
shall be made.
A.2.7 Analysis methods
The analysis methods shall be capable of detecting the target microbes effectively, have
acceptable sensitivity and related records. On the premise of ensuring the sensitivity,
several samples may be mixed for detection. If positive result is detected, location of the
positive sample shall be further determined. If necessary, gene technology can be used to
analyze enterobacter sakazakii sources and the related information of contamination route
of powdered formulae for infants and children.
A.2.8 Data management
The monitoring plan shall contain data record and evaluation system, e.g. trend analysis.
The data must be subject to continuous evaluation so as to modify and adjust the
monitoring plan properly. Effective management shall be performed on the data of
enterobacteriaece and enterobacter sakazakii, so as the neglected mild or intermittent
contamination may be found.
A.2.9 Corrective measures of positive results
The monitoring plan aims to find whether the target microbe exists in environment.
Before formulating the monitoring plan, acceptance standard and corresponding measures
shall be prepared. The monitoring plan shall specify specific measures and clarify the
corresponding reasons. The relevant measures include being action-less (no risk of
contamination), enhancing cleaning, tracing contamination sources (adding
environmental test), evaluating hygiene measures, detaining and testing products.
The manufacturers shall formulate the measures after detecting enterobacteriaece and
enterobacter sakazakii, so as to response accurately in case of exceeding standard. The
hygiene procedures and control measures shall be evaluated. When salmonella is detected,
corrective actions shall be taken immediately. The trend of enterobacter sakazakii and the
change in quantity of enterobacteriaece shall be evaluated. And the action to be taken
shall depend on the possibility that the products are contaminated by salmonella and
enterobacter sakazakii.
......
GB/T 23790-2009
Good manufacturing practice for infant formula factory
ICS 67.040
X82
National Standards of People's Republic of China
Infant formula powder Good manufacturing practice
Posted 2009-05-18
2009-12-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
This standard by the National Standardization Technical Committee special dietary and centralized.
This standard was drafted. Chinese Food Fermentation Industry Research Institute.
The main drafters of this standard. Tu Shun-ming, Chen Yan, Qiu Kai, firewood Qiuer.
Infant formula powder Good manufacturing practice
1 Scope
This standard specifies the infant formula powder production enterprises in the purchase of raw materials, processing, packaging and transportation and other process-related personnel, construction
Buildings, facilities, equipment set up, as well as health, production processes, product quality management should meet the conditions and requirements to ensure the provision of safe,
By healthy products.
This standard applies to infant formula companies.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB 2760 Hygienic standards for uses of food additives
GB 5749 drinking water health standards
GB 12693 Dairy Good manufacturing practice
GB 13432 prepackaged foods for special dietary uses food labels General
GB 14880 Fortified Food hygiene standards
GB 14881 food companies General hygienic practices
GB/T 18204.1 air in public places Determination of aerobic bacterial microbial test methods
GB 19301 standard milk hygiene
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
October age to 12 months old.
3.2
6 months to 12 months old.
3.3
12 months to 36 months of age.
3.4
With milk (or other edible animal milk) and processed products, soybean and its processed products as the main raw material, adding an appropriate amount of subsistence
Vitamins, minerals and other ingredients, just the physical process for producing a powdery product processing made. Products, including powdered infant formula and powdered
Older infants and infant formula food.
3.5
All raw materials and packaging materials infant formula powder used in the production process. It refers to the original raw materials used in processed foods, including
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