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biological drug

biological drug, Total:159 items.

In the international standard classification, biological drug involves: Company organization and management, Water quality, Medical sciences and health care facilities in general, Pharmaceutics, Vocabularies, Pesticides and other agrochemicals, Environmental protection, Quality, Test conditions and procedures in general, HEALTH CARE TECHNOLOGY, Sterilization and disinfection, Products of the chemical industry, Farming and forestry, Services, Veterinary medicine, Microbiology, Animal feeding stuffs, Protection against dangerous goods, Buildings.


Professional Standard - Agriculture, biological drug

Yunnan Provincial Standard of the People's Republic of China, biological drug

Professional Standard - Chemical Industry, biological drug

工业和信息化部, biological drug

  • HG/T 5925-2021 Biological agent nitrifying agent for water treatment
  • HG/T 5926-2021 Biological agent denitrification agent for water treatment
  • JB/T 20206-2022 Biopharmaceutical reaction process temperature control device

RU-GOST R, biological drug

  • 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 28085-2013 Medicine remedies biological for veterinary use. Method of bacteriological control of sterility
  • GOST R 55291-2012 Probiotic medicine remedies for veterinary use. Methods of microbiological analysis
  • GOST 31928-2013 Probiotics medicine remedies for veterinary use. Methods for determination of the probiotics microorganisms
  • GOST 33275-2015 Biological medicine remedies for veterinary use. Vaccines fowl pox. Specifications
  • GOST 24061-2012 Medicine remedies biological lyophilized for veterinary use. Method for determination mass moisture

Professional Standard - Hygiene , biological drug

  • WS/T 248-2005 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria

American Society for Testing and Materials (ASTM), biological drug

  • ASTM F1481-94(2001) Standard Guide for Ecological Considerations for the Use of Bioremediation in Oil Spill Response-Sand and Gravel Beaches
  • ASTM E2537-08 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing
  • ASTM E1298-89(2000) Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
  • ASTM E1298-89(1994) Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
  • ASTM E1298-06 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
  • ASTM E2500-07(2012) Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • ASTM E2363-23 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
  • ASTM E2500-13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • ASTM E1427-00 Standard Guide for Selecting Test Methods to Determine the Effectiveness of Antimicrobial Agents and Other Chemicals for the Prevention, Inactivation and Removal of Biofilm
  • ASTM E1427-00e1 Standard Guide for Selecting Test Methods to Determine the Effectiveness of Antimicrobial Agents and Other Chemicals for the Prevention, Inactivation and Removal of Biofilm
  • ASTM E2537-16 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
  • ASTM E2458-06 Standard Practices for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being Biological Agents from Nonporous Surfaces
  • ASTM E1567-93(2001) Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations
  • ASTM E2500-20 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • ASTM E1567-93 Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations
  • ASTM E2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

US-FCR, biological drug

Malaysia Standards, biological drug

  • MS 1044 Pt.3-1998 Specification for mosquito vaporizing mats:Part 3:Method for the evaluation of biological efficacy-Glass cylinder method
  • MS 23 Pt.3-1998 Specification for mosquito coils:Part 3:Method for the evaluation of biological efficacy-peet grady method

Beijing Provincial Standard of the People's Republic of China, biological drug

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

Professional Standard - Environmental Protection, biological drug

  • HJ 1256-2022 Technical guidelines for self-monitoring of pollutant discharge units
  • HJ 1062-2019 Pollutant Discharge Permit Application and Issuance Technical Specifications Pharmaceutical Industry-Biological Pharmaceutical Products Manufacturing

Korean Agency for Technology and Standards (KATS), biological drug

  • KS J 0015-2010 Quality manual in biopharmaceutical production based on current Good Manufacturing Practice
  • KS J 0020-2010(2021) Production system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0017-2010(2021) Quality system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0015-2010(2021) Quality manual in biopharmaceutical production based on current Good Manufacturing Practice
  • KS J 0018-2010(2021) Materials system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0021-2010(2021) Packaging and labelling system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0020-2010 Production system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0022-2010 Laboratory control system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0018-2010 Materials system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0016-2010(2021) Facility and equipment system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0022-2010(2021) Laboratory control system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0017-2010 Quality system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0021-2010 Packaging and labelling system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0016-2010 Facility and equipment system policy in biopharmaceutical production based on Good Manufacturing Practice

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, biological drug

ISA - International Society of Automation, biological drug

Group Standards of the People's Republic of China, biological drug

  • T/HFZX 005-2022 Code for green design of biomedical products
  • T/QME 0011-2023 Evaluation criteria for scientific and technological achievements in the bio-pharmaceutical field
  • T/SHDSGY 184-2023 Biomedical product design and brand management standards
  • T/SZCC 001-2023 Shenzhen biomedicine Industry "industrial upstairs"Design guidelines

Shanghai Provincial Standard of the People's Republic of China, biological drug

  • DB31/ 373-2010 Pollutant Discharge Standards for the Biopharmaceutical Industry

Zhejiang Provincial Standard of the People's Republic of China, biological drug

  • DB33/ 923-2014 Pollutant Discharge Standards for Biopharmaceutical Industry

国家药监局, biological drug

  • YY/T 0688.1-2023 Performance evaluation of infectious pathogen susceptibility testing and antimicrobial susceptibility testing equipment Part 1: Broth microdilution reference method for the detection of in vitro activity of antimicrobial agents against fast-growing aerobi

U.S. Environmental Protection Agency (U.S. EPA), biological drug

GB-REG, biological drug

CU-NC, biological drug

Jiangsu Provincial Standard of the People's Republic of China, biological drug

  • DB32/ 3560-2019 Discharge limits of water and air pollutants in the biopharmaceutical industry

Professional Standard - Commodity Inspection, biological drug

  • SN/T 2374-2009 Protocol of inspection for biopesticides of Metarhizium and Beauveria
  • SN/T 1823-2006 Common drugs and methods of sanitary treatment for medical vectors

农业农村部, biological drug

  • NY/T 2888.1-2016 Fungal microbial pesticide Trichoderma Part 1: Trichoderma mother drug
  • NY/T 3278.2-2018 Guidelines for Environmental Value Added Testing of Microbial Pesticides Part 2: Water

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