Biopharmaceuticals 1

Biopharmaceuticals 1, Total:66 items.

The international standard classification for "Biopharmaceuticals 1" includes: Sewage water , Medicaments .

The Chinese standard classification for "Biopharmaceuticals 1" includes: Pollutants discharge in general , Vitamins, nutrition, amino acid, enzymes and other biochemicals .

工业和信息化部

JB/T 20206-2022 Temperature control device for biopharmaceutical reaction process

Group Standards of the People's Republic of China

T/APEP 1024-2022 Discharge Standards for Water Pollutants in Bioengineering Pharmaceutical Industry
T/QGCML 2970-2024 Preparation technology of fermented Chinese herbal biological feed for livestock and poultry
T/CAB 2009-2017 Production of antibiotic-free mutton sheep and mutton quality requirements
T/IMAS 070-2024 Organic fertilizers produced by biopharmaceutical intermediate by-products
T/ZJPA 001-2023 Specifications for electronic storage of microbial data in the pharmaceutical industry

Shanghai Provincial Standard of the People's Republic of China

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

Zhejiang Provincial Standard of the People's Republic of China

DB33/ 923-2014 Pollutant Discharge Standards for Biopharmaceutical 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
HJ 1062-2019 Technical specification for application and issuance of pollutant permit Pharmacy industry—Biological pharmaceutical products manufacturing

农业农村部

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

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

GB 21907-2008 Discharge standards of water pollutants for pharmaceutical industry bio-pharmaceutical category

Jiangsu Provincial Standard of the People's Republic of China

DB32/ 3560-2019 Discharge limits of water and air pollutants in the biopharmaceutical industry
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 1764.9-2022 Water Quotas Part 9: Chemicals and Biological Products

Professional Standard - Commodity Inspection

SN/T 1750-2006 Determination of antibiotics residuses in animal derived food-MIA method
SN/T 1751.1-2006 Determination of quinolone residues in animal derived food-Part 1:MIA method

Professional Standard - Agriculture

1326药典化学药和生物制品卷-2010 Chapter 18 Biological Products V. Thrombolytic Drug Urokinase
1329药典化学药和生物制品卷-2010 Chapter 18 Biological Products V. Thrombolytic Drug Reteplase*
1327药典化学药和生物制品卷-2010 Chapter 18 Biological Products V. Thrombolytic Drug Alteplase
1328药典化学药和生物制品卷-2010 Chapter 18 Biological Products V. Thrombolytic Drug Tenecteplase*
1681药典化学药和生物制品卷-2010 Chapter 26 Ophthalmic Drugs Section 10 Biological Products and Biochemical Drugs Recombinant Human Interferon a1b
1325药典化学药和生物制品卷-2010 Chapter 18 Biological Products V. Thrombolytic Drug Streptokinase
2409药典二部-2010 Appendix XIX B Guidelines for human bioavailability and bioequivalence testing of pharmaceutical preparations

Hubei Provincial Standard of the People's Republic of China

DB42/T 2083.1-2023 Technical Regulations for Biological Control of Main Pests and Diseases of Traditional Chinese Medicinal Plants Part 1: Coptis Rhizome

Shanxi Provincial Standard of the People's Republic of China

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

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 E2537-16 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 E2500-20 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 E1567-93(2001) Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations
ASTM E3326-22 Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry
ASTM E3077-17 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers

ET-QSAE

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

ISA - International Society of Automation

ISA AUTOMTN APPL BIO-PHARM-2008 Automation Applications in Bio-Pharmaceuticals

SCC

MIL MIL-STD-964-1974 MANUFACTURE AND PACKAGING OF DRUGS, PHARMACEUTICALS AND BIOLOGICAL PRODUCTS (NO S/S DOCUMENT)
AAMI CR513:2024 Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing
DIN 26055-1 E:2009 Draft Document - Hose assemblies for use in the pharmaceutical and biotechnological industry with hoses of non-metallic materials - Part 1: Hoses made of PTFE and derivatives

Korean Agency for Technology and Standards (KATS)

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

US-FCR

FCR 21 CFR PART 226-2013 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
FCR 21 CFR PART 226-2015 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
FCR 21 CFR PART 290-2013 CONTROLLED DRUGS
FCR 21 CFR PART 290-2014 CONTROLLED DRUGS
FCR 21 CFR PART 290-2015 CONTROLLED DRUGS

US-HHS

HHS 21 CFR PART 226-2011 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
HHS 21 CFR PART 290-2011 CONTROLLED DRUGS

GSO

GSO ASTM E2500:2021 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

RU-GOST R

GOST R 57688-2017 Medicines for medical applications. Stability testing of biotechnological/biological medications
GOST 28085-2013 Medicine remedies biological for veterinary use. Method of bacteriological control of sterility
GOST R 57679-2017 Medicines for medical applications. Investigation bioequivalence of medications

HU-MSZT

MSZ 19854-1969 medicinal plant, mistletoe

German Institute for Standardization

DIN 26055-1 E:2009-01 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 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

CU-NC

NC 26-92-42-1990 Drugs. Vitamin B6 Tablets Quality Specifications