GB/T 38503-2020 English PDF (GBT38503-2020)

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GB/T 38503-2020: Good manufacturing practice for disinfectant
GB/T 38503-2020
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 50
Good manufacturing practice for disinfectant
ISSUED ON: MARCH 06, 2020
IMPLEMENTED ON: OCTOBER 01, 2020
Issued by: State Administration for Market Regulation;
Standardization Administration 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 Organizational structure and personnel ... 6
5 Plant, facilities and equipment ... 7
6 Materials ... 9
7 Production management ... 11
8 Hygiene requirements ... 12
9 Validating ... 14
10 Quality management ... 15
11 Product sales and service ... 17
12 Complaints and reports ... 17
Good manufacturing practice for disinfectant
1 Scope
This Standard specifies the organizational structure and personnel of disinfectant
production enterprises, plant facilities and equipment, materials, production
management, hygiene requirements, verification, quality management, product sales
and services, complaints and reports.
This Standard applies to the production (including packaging) of disinfectants.
This Standard does not apply to the production (including sub-packaging) enterprises
of biological disinfectants.
2 Normative references
The following referenced files are indispensable for the application of this file. For
dated references, only the edition cited applies. For undated references, the latest edition
of the referenced file (including any amendments) applies.
GB/T 191, Packaging and storage marks
GB 5749, Standards for drinking water quality
GB 8978, Integrated wastewater discharge standard
GB 16297, Integrated emission standard of air pollutants
GB 50073-2013, Code for design of clean room
GB/T 38598-2020, General Requirement for Label and Instructions Book of
Disinfection Products
GBZ 1, Hygienic standards for the design of industrial enterprises
Pharmacopoeia of the People's Republic of China
Hygienic Standards for Disinfection Products Production enterprises (Health
Supervisory Fa [2009] No. 53)
3 Terms and definitions
For the purposes of this file, the following terms and definitions apply.
3.1 decontaminating
The process of removing contaminants in order to obtain the necessary degree of
cleanliness.
3.2 state marker
A mark used to indicate the state of raw materials, semi-finished products, products,
containers, and equipment.
3.3 to be tested
The state of materials, semi-finished products and finished products on hold, waiting
for inspection results.
3.4 validating
A documented set of activities that demonstrates that any procedure, process, equipment,
material, activity or system actually achieves the intended result.
3.5 files
All written standards related to the production and management of disinfectants and
recorded results during implementation.
3.6 quality system
In order to ensure that the quality of products, processes or services meets specified or
potential requirements, it is an organic whole composed of organizational structure,
responsibilities, procedures, activities, capabilities and resources.
3.7 work instruction; WI
Procedures established to assure the quality of a process.
3.8 standard operation procedure; SOP
General files or management methods approved to guide operations.
3.9 batch number
A set of numbers, letters, or a combination of letters and numbers used to identify the
"batch".
3.10 critical control point
In order to ensure that the process is in a controlled state, within a certain time and
under certain conditions, the quality characteristics, key parts or weak links that need
to be controlled in the product manufacturing process.
3.11 production record of block
All production records for a batch of ready-to-package or finished product. The
production record of block can provide the production history and quality-related
information of the batch.
3.12 production batch
Products of the same specification produced under the same production conditions with
the same batch of raw materials and auxiliary materials.
NOTE: The same production conditions refer to the same product formula, production process and
shift.
4 Organizational structure and personnel
4.1 Organizational structure
4.1.1 The production enterprise shall establish an organizational structure that is
compatible with the disinfectant production and quality management system to stipulate
the responsibilities and interrelationships in quality management.
4.1.2 The production enterprise shall be equipped with management personnel
(including internal auditors) and technical personnel with relevant professional
knowledge, production experience and organizational capabilities that are suitable for
the disinfectants they produce.
4.1.3 The quality management department of the production enterprise shall be
responsible for the quality management and inspection of the whole process of
disinfectant production and shall be directly led by the person in charge of quality of
the enterprise. The quality management department shall be equipped with a certain
number of quality managers and inspectors with relevant professional knowledge,
production experience and organizational capabilities that are suitable for the
disinfectants it produces. The quality management department has the right to deny
product quality problems.
4.1.4 The heads of the production management department and the quality management
department of the production enterprise shall not concurrently serve as each other.
4.2 Personnel
4.2.1 The person in charge of technology and quality of the production enterprise shall
have a bachelor’s degree or above in a relevant major and more than 3 years of relevant
work experience in disinfectant production and quality management.
4.2.2 The person in charge of the production management department of the production
able to withstand washing and disinfection. The junction of the wall and the ground
shall be curved, or other measures shall be taken to reduce dust accumulation and
facilitate cleaning.
5.2.2 The production workshop shall determine a reasonable process layout according
to the process flow of the product. The process layout shall be connected reasonably
according to the sequence of processes. Avoid the intersection of people and logistics.
The design of the clean workshop shall meet the requirements of GB 50073-2013.
5.2.3 The equipment shall have enough room to operate. The layout shall be reasonable
according to the production process, so that the materials in the production and
processing process flow in the same direction to avoid round trips.
5.3 Production facilities
5.3.1 Changing rooms shall be equipped with flowing water for washing hands,
disinfection facilities and hand drying facilities. Faucets shall be non-touch. The clean
decontaminating workshop (area) shall set up a secondary dressing room. And there are
running water washing, disinfection facilities, hand drying facilities and air disinfection
facilities. Faucets shall be non-touch.
5.3.2 Workshops and storage areas that use or produce toxic, harmful, flammable and
explosive materials in the production process shall have corresponding hygiene and
safety facilities and meet the relevant occupational health and safety protection
requirements.
5.3.3 The discharge of waste gas and wastewater from the production enterprise ...