GB 23790-2010 English PDF

GB 23790-2010: National food safety standard -- Good manufacturing practice for powdered formulae for infants and young children
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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 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 s...