GB 29923:2023 National food safety standard -Good manufacturing practice for formulated foods for special medical purposes
1 Scope
This standard specifies the basic requirements and management guidelines for sites, facilities and personnel for raw material purchasing, processing, packaging, storage and transportation in the production process of formulated foods for special medical purposes.
This standard is applicable to the production of formulated foods for special medical purposes.
2 Terms and definitions
For the purposes of this standard, the terms and definitions given in GB 14881, GB 25596 and GB 29922 apply.
3 Site selection and plant environment
The relevant requirements of GB 14881 shall be met.
4 Plant buildings and workshops
4.1 Basic requirements
The relevant requirements of GB 14881 shall be met.
4.2 Design and layout
4.2.1 The plant buildings and workshops shall be reasonably designed, planned and constructed to adapt to the facilities and equipment, so as to prevent microbial contamination and microbial breeding, especially the contamination of pathogenic bacteria such as Salmonella. For infant formula for special medical purposes, the contamination of Cronobacter (Enterobacter sakazakii) shall also be avoided. The following aspects shall be considered during the design:
a) wet areas shall be effectively separated from dry areas, and cross-contamination caused by the flow of personnel, equipment and materials shall be effectively controlled;
b) the stacking of materials shall be reasonably arranged to avoid places that are hard to cleaning due to improper stacking;
c) gaps of pipes, cables passing through the floors, ceilings and walls of buildings shall be well enclosed or sealed;
d) the wet cleaning process shall be designed reasonably, and improper wet cleaning shall be prevented in dry areas; and
e) the clean working area shall be free of condensed water.
4.2.2 The operation in dry processing area without subsequent sterilization (or disinfection), such as from drying (or post-drying) procedure to filling and sealed packaging, shall be carried out in a clean working area.
4.2.3 For products with subsequent sterilization (or disinfection), contact with ambient air (such as weighing and batching) before sterilization (or disinfection), and wet processing areas of powdery products (such as weighing, batching and concentration) may be carried out in quasi-clean working areas, but their safety shall be verified according to the requirements of 9.2 and 9.4 to ensure the quality and safety of products.
4.2.4 Effective separation shall be set between working areas with different cleanliness levels. An independent air purification system with filtration device shall be installed in the clean working area, and it shall maintain a positive pressure to prevent unpurified air from entering the clean working area and causing cross-contamination.
4.2.5 The clean working area shall be kept dry. Water supply facilities and systems shall not cross the upper space of the main production surface. Otherwise, protective measures shall be taken to prevent contamination.
4.2.6 Reasonable and effective control measures shall be taken when entering and leaving the clean working area to avoid or reduce microbial contamination and other contamination. Personnel, raw materials, packaging materials, wastes and equipment, etc. entering and leaving the clean working area shall be provided with measures to prevent cross-contamination, such as setting up personnel locker rooms to replace work clothes, work shoes or shoe covers, removing or cleaning and disinfecting the outer packaging of the materials entering the clean working area, sealing the special logistics channels, waste channels or wastes, and ensuring the intact sealing protection of waste. For airborne materials transported through pipes to the clean working area, an appropriate air filtration system shall be designed and installed for carrier airflow.
4.2.7 The environment of clean working area shall meet the requirements of Table 1. For the production of infant formula for special medical purposes, the environment of clean working area shall also meet the requirements of GB 23790; the number of sediment bacteria in the air of quasi-clean working area shall be less than or equal to 30CFU/dish (determined according to GB/T 16294 for 5min), and shall be monitored and recorded.
Table 1 Environmental and dynamic control requirements of clean working areas of formulated foods for special medical purposes
Foreword
1 Scope
2 Terms and definitions
3 Site selection and plant environment
4 Plant buildings and workshops
5 Facilities and equipment
6 Hygiene management
7 Food raw materials, additives and related products
8 Food safety control in production process
9 Verification
10 Inspection
11 Storage and transportation of food
12 Product recall management
13 Training
14 Management system and personnel
15 Record and document management
Annex A Application guide for computer system in enterprise of formulated foods for special medical purposes
Annex B Guide for environmental monitoring of Salmonella, Cronobacter (Enterobacter sakazakii) and Enterobacteriaceae in clean working area for powdery formulated foods for special medical purposes
Annex C Guide for commercial disinfection of liquid formulated foods for special medical purposes
