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  2. Standards for A class of chemical and biological drugs

A class of chemical and biological drugs

A class of chemical and biological drugs, Total:416 items.

The international standard classification for "A class of chemical and biological drugs" includes: Other standards related to pharmaceutics , Pesticides and other agrochemicals , Sewage water , Medical Sciences and health care facilities in general , Workplace atmospheres .

The Chinese standard classification for "A class of chemical and biological drugs" includes: Traditional Chinese medicinal materials , Pesticide management and application method , Pollutants discharge in general , Medical science , Pesticide , Labor sanitation , Pharmaceutical in general .

Professional Standard - Agriculture

Group Standards of the People's Republic of China

  • T/APEP 1026-2022 Discharge Standards for Water Pollutants of Traditional Chinese Medicine Pharmaceutical Industry
  • T/APEP 1024-2022 Discharge Standards for Water Pollutants in Bioengineering Pharmaceutical Industry
  • T/SHMHZQ 022-2022 Technical specification for the production of pharmaceutical tablets
  • T/SOFIDPA 0003-2022 Technical specification for integration of water, fertilizer and medicine for hill and mountain perennials
  • T/ZJPA 001-2023 Specifications for electronic storage of microbial data in the pharmaceutical industry
  • T/ZAII 018-2019 Function framework for integrated management and control of pharmaceutical production
  • T/CAB 2009-2017 Production of antibiotic-free mutton sheep and mutton quality requirements
  • T/HLJSPP 01-2024 Guideline on risk assessment for pesticide residues in plant crude drugs
  • T/SDNY 031-2022 Pesticide Industry Intelligent Assessment Standardizes Pesticide Technical Production
  • T/SDAS 720-2023 Hygienic specifications for the production of yam powder products
  • T/APEP 1021-2022 Discharge Standards for Water Pollutants in Chemical Synthesis Pharmaceutical Industry
  • T/CACM 1374.1-2021 General rules of technical regulations for standardized production of traditional Chinese medicinal materials
  • T/CATCM 014-2021 Requirements for traditional Chinese medicine traceability information—Seed and seedlings production(plants)
  • T/SHZSAQS 00285-2024 Detection of antibiotic residues in manure from large-scale pig farms

工业和信息化部

  • HG/T 5926-2021 Biological agents for water treatment—Denitrifying microbial agents
  • HG/T 5925-2021 Biological agents for water treatment——Nitrifying microbial agents

Taiwan Provincial Standard of the People's Republic of China

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

  • GB/T 29566-2013 The bioassay methods for mosquitoesresistance to insecticides
  • GB/T 26350-2010 Test methods of fly resistance to insecticides—The bioassay methods for musca domestica
  • GB 21904-2008 Discharge standards of water pollutants for pharmaceutical industry chemical synthesis products category
  • GB/T 31720-2015 Insecticide resistance management for vector―General rules
  • GB/T 17980.45-2000 Pesticide-Guidelines for the field efficacy trials(Ⅰ)-Herbicides against weeds in rapes
  • GB/T 17980.43-2000 Pesticide - Guidelines for the field efficacy trials (I) - Herbicides against weeds in leafy vegetables
  • GB 21907-2008 Discharge standards of water pollutants for pharmaceutical industry bio-pharmaceutical category
  • GB/T 17980.46-2000 Pesticide - Guidelines for the field efficacy trials (I) - Herbicides against weeds in outdoor fruit vegetables
  • GB/T 17980.41-2000 Pesticide - Guidelines for the field efficacy trials (I) - Herbicides against weeds in cereals

中华人民共和国环境保护部

  • GB 21906-2008 Discharge standards of water pollutants for pharmaceutical industry chinese traditional medicine category

Occupational Health Standard of the People's Republic of China

Professional Standard - Chemical Industry

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

Beijing Provincial Standard of the People's Republic of China

Yunnan Provincial Standard of the People's Republic of China

  • DB5301/T 52-2021 Discharge limits of water pollutants in traditional Chinese medicine pharmaceutical industry

中华人民共和国国家卫生和计划生育委员会

  • WS/T 115-1999 Biological limit values for occupational exposure to organophosphate insecticides

Professional Standard - Commodity Inspection

  • SN/T 1750-2006 Determination of antibiotics residuses in animal derived food-MIA method

Professional Standard - Medicine

  • YY/T 0188.6-1995 Operating methods for the tests and assays of drugs. Part 6: Biological assays of drugs

农业农村部

  • NY/T 2888.1-2016 Fungal pesticides. Trichoderma spp.. Part 1:Trichoderma spp. technical concentrates(TK)

Hebei Provincial Standard of the People's Republic of China

  • DB13/T 5442-2021 Technical regulations for reducing chemical fertilizer and pesticide application in seed potato production in the first cropping area

Xinjiang Provincial Standard of the People's Republic of China

  • DB65/T 4175-2018 Production technical regulations for peanuts with reduced application of chemical fertilizers and pesticides

Zhejiang Provincial Standard of the People's Republic of China

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

Professional Standard - Military and Civilian Products

  • WJ 1990-1990 Terms of Physicochemical Analysis of Gunpowder and Explosives

HU-MSZT

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 E2500-07(2012) Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • ASTM E2537-08 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing
  • 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 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 E2756-24 Standard Terminology Relating to Antimicrobial and Antiviral Agents
  • ASTM E2500-20 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

ISA - International Society of Automation

CU-NC

U.S. Military Regulations and Norms

US-CFR-file

  • CFR 21-316.22-2013 Food and drugs. Part316:Orphan drugs. Section316.22:Permanent-resident agent for foreign sponsor.
  • CFR 21-316.20-2013 Food and drugs. Part316:Orphan drugs. Section316.20:Content and format of a request for orphan-drug designation.
  • CFR 21-558.415-2014 Food and drugs. Part558:New animal drugs for use in animal feeds. Section558.415:Novobiocin.
  • CFR 21-316.1-2013 Food and drugs. Part316:Orphan drugs. Section316.1:Scope of this part.
  • CFR 21-514.11-2014 Food and drugs. Part514:New animal drug applications. Section514.11:Confidentiality of data and information in a new animal drug application file.
  • CFR 21-316.26-2013 Food and drugs. Part316:Orphan drugs. Section316.26:Amendment to orphan-drug designation.
  • CFR 21-520.622b-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.622b:Diethylcarbamazine citrate syrup.
  • CFR 21-316.34-2013 Food and drugs. Part316:Orphan drugs. Section316.34:FDA recognition of exclusive approval.

SCC

  • MIL MIL-STD-964-1974 MANUFACTURE AND PACKAGING OF DRUGS, PHARMACEUTICALS AND BIOLOGICAL PRODUCTS (NO S/S DOCUMENT)
  • AWWA WQTC65930 Chlorination of Pharmaceuticals
  • MIL MIL-PRF-32076-2000 UNITIZATION OF AMMUNITION
  • AWWA WQTC71516 Ozone Oxidation of Chemotherapy Drugs and Pharmaceuticals during Drinking Water Treatment
  • AAMI CR513:2024 Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing
  • AWWA WQTC71459 Comparison of Caffeine and Human Pharmaceutical Compounds as Indicators of Sewage-Derived Microbes in Urban Marine Systems
  • AWWA WQTC69492 Ozone Oxidation of Pharmaceuticals, Pesticides and Endocrine Disruptors during Drinking Water Treatment
  • AWWA MTC69668 Removal of Algal Toxins, Steroids and Pharmaceuticals during Pacific Ocean Seawater Desalination

US-FCR

European Committee for Standardization (CEN)

  • EN 374-3:1994 Protective Gloves Against Chemicals and Micro- Organisms - Part 3: Determination of Resistance to Permeation by Chemicals
  • prEN 374-3-1992 Protective gloves against chemicals and micro-organisms; part 3: determination of resistance to permeation by chemicals
  • prEN 374-5-1990 Protective gloves against chemicals and micro-organisms; part 5: determination of resistance to permeation by chemicals

US-HHS

RU-GOST R

  • GOST R 57688-2017 Medicines for medical applications. Stability testing of biotechnological/biological medications
  • GOST R 57647-2017 Medicines for medical applications. Pharmacogenomics. Biomarkers
  • GOST R 57679-2017 Medicines for medical applications. Investigation bioequivalence of medications
  • GOST R 59326-2021 Milk and milk raw material. Determination of veterinary drugs and chemotherapeutic drugs by enzyme immunoassay with chemiluminescent detection using biochip technology
  • GOST R 56699-2015 Medicines for medical applications. Preclinical safety evaluation of biotechnology-derived pharmaceuticals. General recommendations
  • GOST R 55291-2012 Probiotic medicine remedies for veterinary use. Methods of microbiological analysis

ZA-SANS

  • SANS 6095:2009 Stock remedies - Efficacy of chemicals against adult ticks
  • SANS 6094:2009 Stock remedies - Efficacy of chemicals against tick larvae
  • SANS 5550:2009 Potency of antibiotics - Microbiological agar diffusion method of assay (two-point technique)
  • SANS 10304-1:2002 The classification of pesticides and stock remedies for sale and handling in South Africa Part 1: The classification of pesticides

Compressed Gas Association (U.S.)

  • CGA M-2-2013 GENERAL GUIDE FOR THE MANUFACTURE OF MEDICAL GASES CLASSIFIED AS DRUGS

International Organization for Standardization (ISO)

  • ISO 19617:2018 Traditional Chinese medicine — General requirements for the manufacturing process of natural products

Japanese Industrial Standards Committee (JISC)

Association Francaise de Normalisation

  • NF S75-501-3:1994 PROTECTIVE GLOVES AGAINST CHEMICALS AND MICRO-ORGANISMS. PART 3 : DETERMINATION OF RESISTANCE TO PERMEATION BY CHEMICALS. (EUROPEAN STANDARD EN 374-3).

Military Standards (MIL-STD)

British Standards Institution (BSI)

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

YU-JUS

GSO

AR-IRAM

BE-NBN

  • NBN-EN 374-3-1994 Protective gloves against chemicals and micro-organisms - Part 3 : Determination of resistance to permeation by chemicals

CZ-CSN

  • CSN 66 4051-1965 General requirements for liquid medicaments
  • CSN ON 65 5759-1966 Biological Testing of Pesticides. Determination of Aparicidal Actrvity of Pesticidal Sprays.
  • CSN ON 65 5758-1966 Biological Testing of Pesticides. Determination of Biological Activity oí Seed Dressings.

BELST

  • STB 2436-2016 Mineral medicinal-table waters. General specifications
  • STB 880-2016 Mineral natural medicinal-table waters. General specifications

A class of chemical and biological drugs

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