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Frontiers of Biopharmaceuticals

Frontiers of Biopharmaceuticals, Total:208 items.

In the international standard classification, Frontiers of Biopharmaceuticals involves: Quality, Medical sciences and health care facilities in general, Pharmaceutics, Test conditions and procedures in general, Vocabularies, Environmental protection, HEALTH CARE TECHNOLOGY, Water quality, Veterinary medicine, Medical equipment, Microbiology, Farming and forestry, Pesticides and other agrochemicals, Pipeline components and pipelines, Products of the chemical industry.


Korean Agency for Technology and Standards (KATS), Frontiers of Biopharmaceuticals

  • KS J 0015-2010(2021) 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 0022-2010(2021) Laboratory control 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 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 0016-2010(2021) Facility and equipment system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS P ISO 8871-4:2010 Elastomeric parts for parenterals and for devices for pharmaceutical use－Part 4：Biological requirements and test methods
  • KS I ISO 9509-2008(2018) Water quality－Method for assessing the inhibition of nitrification of activated sludge micro organisms by chemicals and wastewaters

RU-GOST R, Frontiers of Biopharmaceuticals

  • 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 28083-2012 Biological medicinal remedies lyophilized for veterinary use. Method of control of vacuum in ampules and bottles

American Society for Testing and Materials (ASTM), Frontiers of Biopharmaceuticals

  • ASTM E2363-23 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
  • ASTM E2537-16 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
  • ASTM E2500-13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • ASTM E2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • ASTM E2500-20 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • ASTM E3326-22 Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry
  • ASTM E1567-93(2001) Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations
  • ASTM E3077-17 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
  • ASTM E3077-17e2 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
  • ASTM E1567-93 Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations
  • ASTM E3051-16 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
  • ASTM E3077-17e1 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
  • ASTM E3230-20 Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing

Group Standards of the People's Republic of China, Frontiers of Biopharmaceuticals

  • T/SZDT 006-2023 Guidelines for vector control work along municipal roads
  • T/CAB 2009-2017 Production of antibiotic-free mutton sheep and mutton quality requirements
  • T/APEP 1024-2022 Discharge Standards for Water Pollutants in Bioengineering Pharmaceutical Industry
  • T/ZJPA 001-2021 Technical consideration of environmental microbial database construction in pharmaceutical industry

ET-QSAE, Frontiers of Biopharmaceuticals

Shanghai Provincial Standard of the People's Republic of China, Frontiers of Biopharmaceuticals

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

Zhejiang Provincial Standard of the People's Republic of China, Frontiers of Biopharmaceuticals

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

ISA - International Society of Automation, Frontiers of Biopharmaceuticals

Professional Standard - Agriculture, Frontiers of Biopharmaceuticals

工业和信息化部, Frontiers of Biopharmaceuticals

  • JB/T 20206-2022 Biopharmaceutical reaction process temperature control device

Professional Standard - Environmental Protection, Frontiers of Biopharmaceuticals

  • 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

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Frontiers of Biopharmaceuticals

  • GB 21907-2008 Discharge standard of water pollutants for pharmaceutical industry Bio-pharmaceutical category

Jiangsu Provincial Standard of the People's Republic of China, Frontiers of Biopharmaceuticals

  • DB32/ 3560-2019 Discharge limits of water and air pollutants in the biopharmaceutical industry
  • DB32/T 4555-2023 Technical specifications for preparation and quality control of biochemical drugs of animal origin

US-HHS, Frontiers of Biopharmaceuticals

US-FCR, Frontiers of Biopharmaceuticals

Professional Standard - Commodity Inspection, Frontiers of Biopharmaceuticals

  • SN/T 1750-2006 Determination of antibiotics residues in animal derived food-MIA method
  • SN/T 2127-2008 Determination of β-lactam residues in foodstuffs of animal origin for import and export.MIA method
  • SN/T 1751.1-2006 Determination of quiniline residues in animal derived food--Part 1 :MIA method
  • SN/T 2423-2010 Determination of thiamphenicol and florfenicol residues in animal derived food-MIA method

Beijing Provincial Standard of the People's Republic of China, Frontiers of Biopharmaceuticals

  • DB11/T 1764.9-2022 Water Quotas Part 9: Chemicals and Biological Products
  • DB11/T 1821-2021 Technical Guidelines for Environmental Impact Assessment of Construction Projects Manufacturing of Biopharmaceutical Products

Shanxi Provincial Standard of the People's Republic of China, Frontiers of Biopharmaceuticals

  • DB14/T 2548-2022 Quality Control Bioassay Laboratory Management Specifications for Pharmaceutical Enterprises

US-CFR-file, Frontiers of Biopharmaceuticals

  • CFR 50-660.511-2014 Wildlife and Fisheries. Part660:Fisheries off west coast states. Section660.511:Catch restrictions.
  • CFR 21-600.2-2013 Food and Drugs. Part600:Biological products: general. Section600.2:Mailing addresses.
  • CFR 21-600.90-2014 Food and drugs. Part600:Biological products:general. SubpartD:Reporting of adverse experiences. Section600.90:Waivers.
  • CFR 21-600.2-2014 Food and drugs. Part600:Biological products:general. SubpartA:General provisions. Section600.2:Mailing addresses.
  • CFR 21-600.81-2014 Food and drugs. Part600:Biological products:general. SubpartD:Reporting of adverse experiences. Section600.81:Distribution reports.
  • CFR 50-660.231-2014 Wildlife and Fisheries. Part660:Fisheries off west coast states. Section660.231:Limited entry fixed gear sa-blefish primary fishery.
  • CFR 21-106.55-2014 Food and Drugs. Part106:Infant formula quality control procedures (Eff. until 7-10-14). Section106.55:Controls to prevent adulteration from microorganisms.
  • CFR 21-600.80-2014 Food and drugs. Part600:Biological products:general. SubpartD:Reporting of adverse experiences. Section600.80:Postmarketing reporting of adverse experiences.
  • CFR 21-1301.74-2014 Food and drugs. Part1301:Registration of manufacturers, distributors, and dispensers of controlled substances. Section1301.74:Other security controls for nonpractitioners; narcotic treatment programs and compounders for narcotic treatment programs.

British Standards Institution (BSI), Frontiers of Biopharmaceuticals

  • BS EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Biological requirements and test methods
  • BS EN 84:2020 Durability of wood and wood-based products. Accelerated ageing of treated wood prior to biological testing. Leaching procedure

PT-IPQ, Frontiers of Biopharmaceuticals

  • NP 3106-1985
  • NP 4404-1-2002 Food microbiology preserved and assimilated products Part 1:Control of stability.Test in the oven (Routine method)
  • NP 3105-1985
  • NP EN 73-1991 Wood preservatives Accelerated ageing of treated wood prior to biological testing. Evaporative ageing procedure

国家质量监督检验检疫总局, Frontiers of Biopharmaceuticals

  • SN/T 4747.2-2017 Microbial inhibition method for determination of macrolide drug residues in imported and exported food animals

Hebei Provincial Standard of the People's Republic of China, Frontiers of Biopharmaceuticals

  • DB13/T 5363-2021 Technical Guidelines for the Control of Volatile Organic Compounds and Odor Gas Pollution in Biological and Chemical Pharmaceutical Industries

German Institute for Standardization, Frontiers of Biopharmaceuticals

  • DIN 26055-1:2010 Hose assemblies for use in the pharmaceutical and biotechnological industry with hoses of non-metallic materials - Part 1: Hoses made of PTFE and derivatives
  • DIN EN 84:2020 Durability of wood and wood-based products - Accelerated ageing of treated wood prior to biological testing - Leaching procedure
  • DIN EN 84:2020-10 Durability of wood and wood-based products - Accelerated ageing of treated wood prior to biological testing - Leaching procedure; German version EN 84:2020
  • DIN EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006); English version of DIN EN ISO 8871-4:2006-09
  • DIN EN 73:2020 Durability of wood and wood-based products - Accelerated ageing of treated wood prior to biological testing - Evaporative ageing procedure

SE-SIS, Frontiers of Biopharmaceuticals

  • SIS SMS 2594-1970 Fittings for piping.Sanitary valves.Basin mixer.Metric threaded nose,anti-splash and mechanical waste plug

IT-UNI, Frontiers of Biopharmaceuticals

  • UNI EN 84-2020 Durability of wood and wood-based products - Accelerated ageing of treated wood prior to biological testing - Leaching procedure
  • UNI EN 73-2020 Durability of wood and wood-based products - Accelerated ageing of treated wood prior to biological testing - Evaporative ageing procedure

Lithuanian Standards Office , Frontiers of Biopharmaceuticals

  • LST EN 84-2020 Durability of wood and wood-based products - Accelerated ageing of treated wood prior to biological testing - Leaching procedure
  • LST EN 73-2020 Durability of wood and wood-based products - Accelerated ageing of treated wood prior to biological testing - Evaporative ageing procedure

PL-PKN, Frontiers of Biopharmaceuticals

  • PN-EN 84-2021-01 E Durability of wood and wood-based products - Accelerated ageing of treated wood prior to biological testing - Leaching procedure
  • PN-EN 73-2021-01 E Durability of wood and wood-based products - Accelerated ageing of treated wood prior to biological testing - Evaporative ageing procedure

ES-UNE, Frontiers of Biopharmaceuticals

  • UNE-EN 84:2021 Durability of wood and wood-based products - Accelerated ageing of treated wood prior to biological testing - Leaching procedure

European Committee for Standardization (CEN), Frontiers of Biopharmaceuticals

  • EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)

IX-EU/EC, Frontiers of Biopharmaceuticals

  • 97/389/EC-1997 Council Decision Concerning the Conclusion of an Agreement between the European Community and the United States of America on Precursors and Chemical Substances Frequently Used in the Illicit Manufacture of Narcotic Drugs or Psychotropic Substances

International Organization for Standardization (ISO), Frontiers of Biopharmaceuticals

  • ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods

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