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Norm of water intake - Part 10: Chemical pharmaceutical products
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Norm of water intake -- Part 10: Pharmaceutical products
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Basic data Standard ID | GB/T 18916.10-2021 (GB/T18916.10-2021) | Description (Translated English) | Norm of water intake - Part 10: Chemical pharmaceutical products | Sector / Industry | National Standard (Recommended) | Classification of Chinese Standard | P41 | Word Count Estimation | 8,838 | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration |
GB/T 18916.10-2021: Norm of water intake - Part 10: Chemical pharmaceutical products---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Norm of water intake -- Part 10: Chemical pharmaceutical products
ICS 13:060:25
CCSP41
National Standards of People's Republic of China
Replacing GB/T 18916:10-2006
Water withdrawal quota part 10: chemical pharmaceutical products
Published on 2021-12-31
2022-07-01 Implementation
State Administration for Market Regulation
Released by the National Standardization Administration
foreword
This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents"
drafted:
This document is Part 10 of GB/T 18916 "Water Withdrawal Quota": GB/T 18916 has released the following parts:
--- Part 1: Thermal power generation;
--- Part 2: Iron and steel complexes;
--- Part 3: Petroleum refining;
--- Part 4: Textile dyeing and finishing products;
--- Part 5: Paper products;
--- Part 6: Beer manufacturing;
--- Part 7: Manufacture of alcohol;
--- Part 8: Synthetic ammonia;
--- Part 9: Manufacturing of monosodium glutamate;
--- Part 10: Chemical pharmaceutical products;
--- Part 11: Coal preparation;
--- Part 12: Alumina production;
--- Part 13: Ethylene production;
--- Part 14: Wool textile products;
--- Part 15: Liquor manufacture;
--- Part 16: Production of electrolytic aluminum;
--- Part 17: Accumulation-type bauxite production;
--- Part 18: Copper smelting production;
--- Part 19: Lead smelting production;
--- Part 20: Chemical fiber filament woven products;
--- Part 21: Real silk products;
--- Part 22: Starch sugar manufacture;
--- Part 23: Manufacture of citric acid;
--- Part 24: Hemp textile products;
--- Part 25: Viscose fiber products;
--- Part 26: Soda Ash;
--- Part 27: Urea;
--- Part 28: Industrial sulfuric acid;
--- Part 29: Caustic soda;
--- Part 30: Coking;
--- Part 31: Sintering/pelletizing in the iron and steel industry;
--- Part 32: Iron ore beneficiation;
--- Part 33: Indirect liquefaction of coal;
--- Part 34: Direct liquefaction of coal;
--- Part 35: Coal to methanol;
--- Part 36: Coal-to-ethylene glycol;
--- Part 37: Wet phosphoric acid;
--- Part 38: Polyvinyl chloride;
--- Part 39: Coal to synthetic natural gas;
--- Part 40: Shipbuilding;
--- Part 41: Yeast manufacturing;
--- Part 42: Manufacture of rice wine;
--- Part 43: Ionic rare earth ore smelting and separation production;
--- Part 44: Spandex products;
--- Part 45: Recycled polyester products;
--- Part 46: Nuclear power;
--- Part 47: Polysilicon production;
--- Part 48: Vinyl products;
--- Part 49: Nylon products;
--- Part 50: Polyester polyester products;
--- Part 51: Paraxylene;
--- Part 52: Purified terephthalic acid;
--- Part 53: Sugar;
--- Part 54: Canned food;
--- Part 55: Leather;
--- Part 56: Fur;
--- Part 57: Dairy products;
--- Part 58: Titanium dioxide;
--- Part 59: Vinyl acetate;
--- Part 60: Silicone:
This document replaces GB/T 18916:10-2006 "Water Quota Part 10: Pharmaceutical Products", which is the same as GB/T 18916:10-2006
In contrast, except for structural adjustments and editorial changes, the main technical changes are as follows:
--- Changed the term "pharmaceutical product" to "chemical pharmaceutical product", deleted the terms "water intake for medical product" and "water intake per unit product"
Quantity" (see 3:1, 3:1, 3:4 and 3:5 of the:2006 edition);
--- Changed the water intake quota index (see Chapter 5, Chapter 5 of the:2006 edition);
--- Increase the water intake quota for newly built, renovated and expanded enterprises and the water intake quota for advanced enterprises (see 5:2 and 5:3):
Please note that some content of this document may be patented: The issuing agency of this document assumes no responsibility for identifying patents:
This document is proposed by the Ministry of Water Resources of the People's Republic of China:
This document is under the jurisdiction of the National Water Saving Standardization Technical Committee (SAC/TC442):
This document is drafted by: China Chemical and Pharmaceutical Industry Association, China National Institute of Standardization, Yili Chuanning Biotechnology Co:, Ltd:, North China System
Pharmaceutical Group Co:, Ltd:, Nanjing Jiruikang Biotechnology Research Institute Co:, Ltd:, CSPC Holding Group Co:, Ltd:, Inner Mongolia Changsheng Pharmaceutical
Co:, Ltd:, Northeast Pharmaceutical Group Co:, Ltd:, DSM Jiangshan Pharmaceutical (Jiangsu) Co:, Ltd:, Water Resources Management Center of the Ministry of Water Resources, Luwei
Pharmaceutical Group Co:, Ltd:, Bashan Group Co:, Ltd:, Zhejiang Pharmaceutical Co:, Ltd:, Beijing Yixin Management Consulting Co:, Ltd:
The main drafters of this document: Pan Guangcheng, Zhang Daoxin, Bai Xue, Shen Yunpeng, Ren Liren, Su Rigaqige, Liu Shuyun, Hua Zichun, Feng Chunxiao,
Zhu Jinlin, Lu Lili, Lu Yingzhi, Sun Shuyun, Song Fang, Pan Hongjian:
This document was first published in:2006 and this is the first revision:
Introduction
The verification of water intake is the basis for the state to implement the water intake permit system, implement planned water use management and carry out water resources demonstration: water intake standard
The standard is an important basis for verifying the water intake, and is one of the main indicators for the state to evaluate the water resource utilization efficiency of industries and enterprises and to evaluate the water saving level of enterprises:
First, it is also an important means to implement the strictest water resources management system:
There are many kinds of pharmaceutical products in my country, the process is complex, and the water intake of each product or dosage form in the production process is very different: Vitamin C
(chemical raw materials) and penicillin industrial salts (chemical pharmaceutical intermediates) are the scale advantages of my country's pharmaceutical manufacturing industry:
The two products with the largest volume and export volume: These two products have independent production systems, the technology is relatively mature, the water intake is large, and the vast majority of
Most production enterprises are equipped with water measuring instruments in the main production links: Therefore, currently only vitamin C (chemical raw materials) and
The two products of penicillin industrial salt (chemical pharmaceutical intermediate) formulate the national standard for water intake quota:
GB/T 18916 will clarify the range of water intake, the supply range of water intake and the amount of water intake according to the characteristics of water use in different industries:
It defines the calculation method of water intake quota, divides quota index levels, and makes requirements for quota management:
GB/T 18916 is intended to consist of the following parts:
--- Part 1: Thermal power generation;
--- Part 2: Iron and steel complexes;
--- Part 3: Petroleum refining;
--- Part 4: Textile dyeing and finishing products;
--- Part 5: Paper products;
--- Part 6: Beer manufacturing;
--- Part 7: Manufacture of alcohol;
--- Part 8: Synthetic ammonia;
--- Part 9: Manufacturing of monosodium glutamate;
--- Part 10: Chemical pharmaceutical products;
--- Part 11: Coal preparation;
--- Part 12: Alumina production;
--- Part 13: Ethylene production;
--- Part 14: Wool textile products;
--- Part 15: Liquor manufacture;
--- Part 16: Production of electrolytic aluminum;
--- Part 17: Accumulation-type bauxite production;
--- Part 18: Copper smelting production;
--- Part 19: Lead smelting production;
--- Part 20: Chemical fiber filament woven products;
--- Part 21: Real silk products;
--- Part 22: Starch sugar manufacture;
--- Part 23: Manufacture of citric acid;
--- Part 24: Hemp textile products;
--- Part 25: Viscose fiber products;
--- Part 26: Soda Ash;
--- Part 27: Urea;
--- Part 28: Industrial sulfuric acid;
--- Part 29: Caustic soda;
--- Part 30: Coking;
--- Part 31: Sintering/pelletizing in the iron and steel industry;
--- Part 32: Iron ore beneficiation;
--- Part 33: Indirect liquefaction of coal;
--- Part 34: Direct liquefaction of coal;
--- Part 35: Coal to methanol;
--- Part 36: Coal-to-ethylene glycol;
--- Part 37: Wet phosphoric acid;
--- Part 38: Polyvinyl chloride;
--- Part 39: Coal to synthetic natural gas;
--- Part 40: Shipbuilding;
--- Part 41: Yeast manufacturing;
--- Part 42: Manufacture of rice wine;
--- Part 43: Ionic rare earth ore smelting and separation production;
--- Part 44: Spandex products;
--- Part 45: Recycled polyester products;
--- Part 46: Nuclear power;
--- Part 47: Polysilicon production;
--- Part 48: Vinyl products;
--- Part 49: Nylon products;
--- Part 50: Polyester polyester products;
--- Part 51: Paraxylene;
--- Part 52: Purified terephthalic acid;
--- Part 53: Sugar;
--- Part 54: Canned food;
--- Part 55: Leather;
--- Part 56: Fur;
--- Part 57: Dairy products;
--- Part 58: Titanium dioxide;
--- Part 59: Vinyl acetate;
--- Part 60: Silicone;
--- Part 61: Lysine salts;
--- Part 62: Cement;
--- Part 63: Glass;
--- Part 64: Ceramics:
Water withdrawal quota part 10: chemical pharmaceutical products
1 Scope
This document specifies the calculation method, water intake quota and quota management requirements for chemical and pharmaceutical products:
This document is applicable to the management of water intake in existing, newly built, and renovated and expanded chemical and pharmaceutical product manufacturing enterprises:
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document:
GB/T 12452 General Rules for Enterprise Water Balance Test
GB/T 18820 General Rules for the Compilation of Water Intake Quotas for Industrial Enterprises
GB/T 21534 Terms of Water Conservation
GB 24789 General rules for the provision and management of water measuring instruments for water units
3 Terms and Definitions
The terms and definitions defined in GB/T 18820, GB/T 21534 and the following apply to this document:
3:1
chemicalpharmaceuticalproductschemicalpharmaceuticalproducts
Substances used for the prevention, treatment, diagnosis of human diseases, purposeful regulation of human physiological functions, and prescribed indications, usage and dosage:
Note: It consists of two parts: API production and pharmaceutical preparation production:
3:2
activepharmaceuticalingredient
A single substance or mixture used in the manufacture of a medicinal product which, when used in a medicinal product, becomes an active ingredient of the medicinal product for the purpose of providing the medicinal product:
physical activity or other direct effects:
3:3
chemical intermediates
Intermediates of non-starting and final products used in the preparation of chemical APIs:
4 Calculation method
4:1 General provisions
4:1:1 Scope of water intake
The scope of water withdrawal refers to the amount of water extracted by enterprises from various water sources, including surface water (measured by water supply from water purification plants), groundwater, and urban water supply:
Water works, as well as other water or water products (such as steam, hot water, geothermal water, etc:) purchased by the enterprise from the market:
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