Pharmaceutical Biotechnology

Pharmaceutical Biotechnology, Total:53 items.

The international standard classification for "Pharmaceutical Biotechnology" includes: Plant growing , Biology. Botany. Zoology , Medicaments , Farming and forestry in general , Continuous handling equipment , Other standards related to pharmaceutics .

The Chinese standard classification for "Pharmaceutical Biotechnology" includes: Agriculture and forestry technology , Environmental Condition and General Test Method , Vitamins, nutrition, amino acid, enzymes and other biochemicals , Medicinal herb and product , Technical management , Basic standards and general methods .

Professional Standard - Environmental Protection

HJ 1256-2022 Self-monitoring technology guidelines for pollution sources ―Pharmaceutical industry Chinese traditional medicine category, biological pharmaceutical products category, chemical pharmaceutics preparations category
HJ 1062-2019 Technical specification for application and issuance of pollutant permit Pharmacy industry—Biological pharmaceutical products manufacturing

Group Standards of the People's Republic of China

T/CGAPA 004-2021 Technical guidance of sustainable manufacturing—Plants
T/HZBX 087-2024 Technical specifications for the management of microbial strains of drugs
T/HNP 001-2024 Specification for safety technology in production of smoke generator pesticides
T/CAB 2009-2017 Production of antibiotic-free mutton sheep and mutton quality requirements
T/CACM 1374.1-2021 General rules of technical regulations for standardized production of traditional Chinese medicinal materials
T/SHMHZQ 022-2022 Technical specification for the production of pharmaceutical tablets
T/CI 317-2024 Medicine food homology and medicated diet formula food Technical specifications for prosessing
T/SHPPA 010-2021 Technical requirements for digital quality assurance in pharmaceutical manufacturing
T/QGCML 2970-2024 Preparation technology of fermented Chinese herbal biological feed for livestock and poultry
T/CSES 42-2021 Guidelines for water reuse—Treatment technologies for pharmaceuticals and personal care products in reclaimed water
T/SHPPA 027-2024 Technical requirements for digital twins in advanced pharmaceutical manufacturing

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB 51069-2014 Technical code for traditional Chiese medicine production plant engineering
GB/T 38793-2020 Technical specification of efficacy evaluation for degradation of heterocyclic pesticides by biological products

Henan Provincial Standard of the People's Republic of China

DB4117/T 418-2024 Technical requirements for the production of veterinary Chinese medicine extracts
DB41/T 1868-2019 Green food Chinese yam production technical regulations
DB41/T 1867-2019 Organic food fresh Chinese yam production technical regulations

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 4555-2023 Technical specifications of production and quality control on biochemical drugs of animal sources

Beijing Provincial Standard of the People's Republic of China

DB11/T 1821-2021 Technical Guidelines for Environmental Impact Assessment of Construction Projects Manufacturing of Biopharmaceutical Products

Anhui Provincial Standard of the People's Republic of China

DB34/T 1776-2018 Green food yam production technical regulations
DB34/T 1776-2012 Green food yam production technical regulations

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 38148-2019 Technical specification of efficacy evaluation for degradation of pyrethroid pesticides by biological products
GB/T 38149-2019 Technical specification of efficacy evaluation for degradation of carbamate pesticides by biological products
GB/T 38089-2019 Technical specification of efficacy evaluation for degradation of organophosphorous pesticides by biological products
GB/T 41277-2022 Technical specification of certification for Chinese medicinal materials (medicinal plants) new breeding varieties

Jiangxi Provincial Standard of the People's Republic of China

DB36/T 1145-2019 Green food purple yam production technical regulations

Professional Standard - Agriculture

农业部1425号公告-6-2010 Guiding principles for field test techniques for efficacy evaluation of topical antimicrobials for pets
农业部1425号公告-14-2010 Technical guidelines for the efficacy evaluation test of antimicrobial drugs for bees
农业部1425号公告-3-2010 Technical guidelines for efficacy evaluation tests of antimicrobial agents for silkworms
农业部1425号公告-5-2010 Technical guidelines for efficacy evaluation test of pet topical antimicrobials

Sichuan Provincial Standard of the People's Republic of China

DB51/T 1663-2013 Technical regulations for biological identification of pesticide residues in mulberry leaves

Chongqing Provincial Standard of the People's Republic of China

DB50/T 640-2015 Technical Specifications for Identification of Medicinal Plant Varieties

Gansu Provincial Standard of the People's Republic of China

DB62/T 1222-2004 Green food Pingliang yam production technical regulations

Professional Standard - Military and Civilian Products

WJ 2177-1994 Production Safety Technical Management Regulations for Gunpowder, Explosives, Ammunition, Fuze and Explosives

Professional Standard - Business

SB/T 11036-2013 The requirements of pharmaceutical logistics facilities and equipment technologies

Zhejiang Provincial Standard of the People's Republic of China

DB33/T 713-2008 Technology and management specification for drug cold chain logistics

Liaoning Provincial Standard of the People's Republic of China

DB21/T 2518-2015 Pharmaceutical cold chain logistics technology and management specifications

Hubei Provincial Standard of the People's Republic of China

DB42/T 1640-2021 Technical regulations for biological control of main diseases and insect pests of Chinese herbal medicine Atractylodes macrocephala

IX-EU/EC

87/22/EEC-1986 Council Directive on the Approximation of National Measures Relating to the Placing on the Market of High- Technology Medicinal Products, Particularly Those Derived from Biotechnology
93/41/EEC-1993 Council Directive Repealing Directive 87/22/EEC on the Approximation of National Measures Relating to the Placing on the Market of High- Technology Medicinal Products, Particularly Those Derived from Biotechnology

RU-GOST R

GOST R 57079-2016 Biotechnology. Classification of biotechnology products
GOST R 57688-2017 Medicines for medical applications. Stability testing of biotechnological/biological medications
GOST R 56699-2015 Medicines for medical applications. Preclinical safety evaluation of biotechnology-derived pharmaceuticals. General recommendations
GOST R 52550-2006 Manufacturing of medicinal product. Organizing and technological documentation

ET-QSAE

ES 544-2000 Microbiological testing of antibiotics for medicinal, medicinal and crude pharmaceutical products

American Society for Testing and Materials (ASTM)

ASTM E2363-23 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
ASTM E2537-08 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing

SCC

MIL MIL-STD-964-1974 MANUFACTURE AND PACKAGING OF DRUGS, PHARMACEUTICALS AND BIOLOGICAL PRODUCTS (NO S/S DOCUMENT)

CN-STDBOOK

图书 A-4782 Food Microbiological Testing Technology
图书 3-8529 Textile Microbiological Testing Technology

Association Francaise de Normalisation

XP CEN ISO/TS 17728:2015 Microbiology of the food chain - Sampling techniques for microbiological analysis of food samples

GOSTR

GOST 34285-2017 Food products, food raw materials. Method for the detection of chemotherapeutic drugs by the hemiluminescence immunoenzymatic assay with the use of biochip technology

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