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

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

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GB/T 38503-2020: Good manufacturing practice for disinfectant
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.
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 shall comply with the corresponding requirements of GB 16297 and GB 8978.
5.3.4 The quality management department shall have physical, chemical and microbiological testing laboratories. It shall be equipped with shockproof, air- conditioning, decontaminating and other corresponding facilities according to the needs of the work. Microbiology laboratories shall comply with the relevant national biosafety regulations. The environmental facilities of the sample retention room set up according to the needs shall be able to meet the storage requirements of the retained sample items.
5.3.5 Storage areas shall be kept clean and dry. And there shall be a sufficient number of stacking pads, cargo racks, etc. Make the stored items more than 10 cm away from the wall and the ground. Store the products in different partitions. The marks shall be obvious. The control of lighting, ventilation, temperature, humidity, etc. shall meet the storage requirements of stored items. The safety and sanitation facilities shall meet the requirements of fire protection and sanitation.
The storage area shall be divided into equipment material room. The cleanliness level of the reclaiming environment shall meet the production requirements.
5.3.6 Production operations such as pretreatment, extraction, and concentration of plant disinfectants shall be carried out by good ventilation and dust removal facilities. They shall be strictly separated from the production of finished disinfectants. 5.3.7 Instruments and meters with special requirements shall be placed in a special instrument room. The indoor temperature, humidity, static electricity, vibration and other environmental factors shall meet the special requirements of the instrument. 5.4 Production and inspection equipment
5.4.1 The production and inspection equipment shall meet the requirements of the Hygienic Standards for Disinfection Products Production Enterprises. Production enterprises with decontaminating requirements shall be equipped with microbiological testing equipment that can meet their requirements for microbiological testing of the production environment.
5.4.2 Lubricants and coolants used in production equipment shall not leak or contaminate disinfectants or containers.
5.4.3 Production equipment and pipelines for skin and mucous membrane disinfectants and hand-washing disinfectants shall be made of non-toxic, corrosion-resistant, and easy-to-clean materials, such as 316 stainless steel.
NOTE: 316 is the steel designation of stainless steel. According to the different chemical composition of stainless steel, 316 can be divided into 316L, 316N, 316J1, 316J1L and so on. 5.4.4 Production and inspection equipment shall have installation, use, maintenance and maintenance files.
6 Materials
6.1 Basic requirements
6.1.1 Procedures shall be formulated for the application, supplier evaluation and confirmation, procurement, validating, storage, distribution, and use of materials used in production (including raw and auxiliary materials, packaging materials, labels, instructions, etc., hereinafter referred to as materials).
6.1.2 The materials used in production shall meet the product quality requirements, the relevant quality standards and the relevant requirements of the health and family planning administrative department. Corresponding inspection report or product quality certification materials provided by the supplier shall be provided.
6.1.3 The to be tested, qualified and unqualified materials shall be strictly classified and managed with obvious signs. Unqualified materials shall be stored in a special area and disposed of in a timely manner according to relevant regulations.
6.4.1 They shall comply with the provisions of GB/T 38598. There shall be pictorial marks in accordance with the provisions of GB/T 191.
6.4.2 They shall be printed, distributed, and used after proofreading and approval by the legal representative of the production enterprise or its authorized person. Labels and instruction manuals shall be kept and received by special personnel. The requirements are as follows:
a) Labels and instruction manuals shall be stored in special counters or special warehouses according to varieties and specifications. Issue by batch packing order. Receive according to actual needs.
b) Labels and instruction manuals shall be counted and issued. The recipient checks and signs. The sum of the used amount, the damaged amount and the remaining amount shall be consistent with the received amount. Damaged or remaining labels with batch numbers shall be counted and destroyed by special personnel. c) The distribution, use and destruction of labels and instruction manuals shall be recorded.
7 Production management
7.1 The production enterprise shall formulate detailed production process, standard operating procedures or work instructions. They shall not be changed arbitrarily. If it is necessary to change, they shall go through the revision and approval procedures according to the prescribed procedures.
7.2 During the trial production, the production enterprise shall verify the function and safety of each processing step in the production process that affects the product. Identify critical control points and control parameters. Establish and implement monitoring systems and procedures for correcting deviations.
7.3 Disinfectant production shall be carried out in accordance with approved standard operating procedures or work instructions.
7.4 When receiving and distributing materials, the names, codes, production batch numbers, and quantities of materials shall be accurate and recorded.
7.5 Appropriate and effective product material identification shall be used in the production process.
7.6 The division of product production batches shall at least be able to trace back from the batch number to the batch number of raw materials of this batch of products, the control situation of the production process, relevant production equipment, operators and inspection personnel, site clearance records and quality records, inspection records and sales situation.
7.7 The production enterprise shall have batch production records and file them. Keep them for at least 3 months after the expiry date of the product. The production record of block shall include batching and feeding records, key data records in the production process, production equipment cleaning and (or) disinfection records, site clearance records, calibration and maintenance records, raw material inspection and use records, and inspection records of critical control points.
7.8 The production record of block shall be written clearly, with authentic content and complete data. It shall also include the date and time of the record, the signatures of the operator and reviewer. Correction of clerical errors shall be made with a bar. Sign or stamp the correction. The production record of block shall be filed according to the batch number.
7.9 Product production shall prevent mix-up and cross-contamination. Cleaning, washing and site clearing shall be performed according to relevant procedures. Records shall be kept. At the same time, the following measures shall be taken: a) The production operations of liquid, solid and gas disinfectants shall not be carried out in the same production workshop.
b) The production operations of disinfectants of the same variety and different specifications shall not be carried out on the same production line at the same time.
c) When there are several packaging lines for packaging at the same time, isolation or other effective facilities to prevent contamination or confusion shall be adopted. d) The equipment and containers used in the production process shall have obvious state markers.
7.10 The production enterprise shall identify, register, and isolate unqualified products. It shall evaluate and dispose of them in strict accordance with the prescribed responsibilities and authorities.
7.11 The production enterprise shall analyze relevant information and abnormal situations in the production process and work operations in a timely manner. Identify the existing and possible causes of non-conforming products or other quality problems. Take necessary corrective and preventive actions.
8 Hygiene requirements
8.1 Basic requirements
8.1.1 The production enterprise shall formulate various hygiene management systems. There are sanitation measures to prevent pollution, and special personnel are in charge. 9 Validating
9.1 Conditions for validating
9.1.1 The production enterprise shall conduct validating before products are put into production.
9.1.2 When the following production conditions change, which may affect the product quality, they shall be revalidated:
a) Plants and facilities;
b) Main production equipment and key settings;
c) Main raw and auxiliary materials, packaging material components, specifications, purity and suppliers;
d) Production water;
e) Production process.
9.1.3 According to the characteristics of the product, when the storage condition of the finished product changes, which may affect the product quality, it shall be revalidated. Issue a validating report.
9.1.4 When the production enterprise resumes production after 6 months of suspension, it shall conduct validating. Issue a validating report.
9.1.5 When the production enterprise changes the quality control method, it shall conduct validating according to the validating plan. Issue a validating report. 9.2 Validating content
9.2.1 The validating of plant and facilities shall be carried out in accordance with the validating plan for installation validating, operation validating and performance validating.
9.2.2 Production equipment, key settings, product materials, production process, and product quality verification shall be validated according to the validating plan. 9.2.3 The production enterprises of skin and mucous membrane disinfectants, sterilizers, high-level disinfectants for medical devices, and plant disinfectants shall validate the production water according to the validating plan before going into production. 9.3 Validating requirements
9.3.1 The quality management department of the production enterprise shall propose validating items and formulate validating plans according to the validating objects. Specify the person in charge of the validating and organize the implementation. After the validating is completed, it will be reviewed and approved by the person in charge of the validating.
9.3.2 The data during the validating process, product test results and analysis content shall be archived and preserved in the form of files. Validating files shall include validating plans, validating reports, evaluations and suggestions, approvers, etc. 10 Quality management
10.1 Basic requirements
10.1.1 The quality management department of the production enterprise is responsible for the quality management and inspection of the whole process of disinfectant production.
10.1.2 The production enterprise shall establish internal control standards, operating procedures and release procedures for the inspection of finished products, semi-finished products and materials. The product quality standards, inspection methods and judgment of results shall meet the requirements of corresponding standards and specifications.
10.1.3 The production enterprise shall formulate standard operating procedures for critical control points. Establish inspection system for critical control points. Avoid unqualified products from entering the next production link.
10.1.4 The production enterprise shall formulate inspection methods and sampling methods according to product standards. Product inspection shall be carried out according to the production batch. Those who have not passed the inspection shall not leave the factory.
10.1.5 For measuring instruments used in production and inspection, and equipment that has a significant impact on product quality, the production enterprise shall formulate a calibration plan. Carry out regul...
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