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Pharmacopoeia method validation

Pharmacopoeia method validation, Total:198 items.

The international standard classification for "Pharmacopoeia method validation" includes: Tobacco, tobacco products and related equipment , Pharmaceutics , Sterilization and disinfection , Applications of information technology in general , Surface treatment and coating .

The Chinese standard classification for "Pharmacopoeia method validation" includes: Tobacco , Pharmaceutical, safety machinery and tool in general , Sanitation in general , Crime judging technology , Material Protection .


Group Standards of the People's Republic of China

  • T/HCAA 002-2021 Guidance for verification and validation of quantitative detection methods of pesticide residues in fruits and vegetables
  • T/SHPPA 012-2022 Validation technical requirements for rapid sterility testing method of cellular and gene therapy products
  • T/HNCAA 027-2021 Verification of inspection and testing standard methods

Jilin Provincial Standard of the People's Republic of China

  • DB22/T 2516-2016 Validation specification for a new method for the detection of drug residues in aquatic products

Professional Standard - Agriculture

  • 2421药典 二部-2010 Appendix XXIX O Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
  • 856兽药典 二部-2015 The medicinal materials and decoction pieces not included in this edition of Veterinary Pharmacopoeia in the prescription preparations in the appendix table of contents
  • 331药典 三部-2015 Technical Guideline 9201 General Guidelines for the Validation of Alternative Methods for Microbiological Testing of Drugs 216
  • 11药典 四部-2015 Medicinal materials and decoction pieces not included in this edition of Pharmacopoeia in prescription preparations
  • 330药典 三部-2015 Technical Guide 9101 General Principles of Validation Guidelines for Analytical Methods of Pharmaceutical Quality Standards 213
  • 362药典 三部-2020 Guideline 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
  • 农业部630号公告-11-2006 Technical guidelines for validation of analytical methods for quality control of veterinary chemicals
  • 1756药典 一部-2010 Appendix III Medicinal Materials and Decoction Pieces Not Listed in This Edition of the Pharmacopoeia in Prescription Preparations
  • 289药典 三部-2010 Appendix ⅩVII ⅩVIB Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
  • 1833药典 一部-2010 Appendix XVIII A Guidelines for Validation of Analytical Methods for Quality Standards of Traditional Chinese Medicine
  • 农业部630号公告-6-2006 Guiding principles for verification of analytical methods for quality standards of traditional Chinese medicines and natural medicines for veterinary use
  • 878兽药典 一部-2015 Appendix Contents 9000 Guidelines 9101 Guidelines for Validation of Analytical Methods for Quality Standards of Veterinary Drugs
  • 317药典 四部-2015 9000 Guiding Principles 9101 Guiding Principles for Validation of Analytical Methods for Pharmaceutical Quality Standards
  • 343药典 四部-2020 9000 Guidelines 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
  • 882兽药典 一部-2015 Appendix Contents 9000 Guidelines 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Veterinary Drugs
  • 2408药典 二部-2010 Appendix XXIX A Guidelines for Validation of Analytical Methods for Drug Quality Standards
  • 324药典 四部-2015 9000 Guidelines 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
  • 1837药典 一部-2010 Appendix XVIII E Guidelines for Validation of Alternative Methods for Microbiological Testing of Pharmaceutical Products

农业农村部

  • NY/T 3151-2017 Guideline on the development and validation of analytical methods for pesticides in the soil and water

Military Standard of the People's Republic of China-General Armament Department

Military Standard of the People's Republic of China-Commission of Science,Technology and Industry for National Defence

Taiwan Provincial Standard of the People's Republic of China

  • CNS 13249-1993 General Rules for a Model Third - Party Certification System for Products

国家市场监督管理总局、中国国家标准化管理委员会

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

卫生健康委员会

  • WS/T 685-2020 Analytical method and evaluation requirements of antifungal drugs in disinfectant and antibactertial and bacteriostatic agents

Professional Standard - Machinery

  • JB/T 20091-2007 Guidance on validation of pharmaceutical machinery(equipment)

Professional Standard - Chemical Industry

Professional Standard - Public Safety Standards

  • GA/T 1170-2014 Examination methods for evidence collection from mobile terminals

Professional Standard - Electron

  • SJ/Z 1086-1976 Typical methods for the analysis of cadmium-plating solution

European Committee for Standardization (CEN)

  • prEN 13631-10-2021 Explosives for civil uses - Explosives - Part 10: Method for the verification of the means of initiation of explosives
  • EN ISO 20072:2010 Aerosol drug delivery device design verification - Requirements and test methods
  • EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods
  • EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
  • EN ISO 16140-4:2020 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)
  • CEN ISO/TS 23758:2021 Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products (ISO/TS 23758:2021)

Compressed Gas Association (U.S.)

  • CGA P-8.2-2008 Guideline for validation of air separation unit and cargo tank filling for oxygen usp and nitrogen NF
  • CGA M-6-2013 Guideline for analytical method volidation

International Organization for Standardization (ISO)

  • ISO 20072:2009 Aerosol drug delivery device design verification - Requirements and test methods
  • ISO/IEC GUIDE 28:1982 General rules for a model third-party certification system for products
  • ISO/TS 23758:2021 | IDF/RM 251 Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products
  • ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory
  • ISO/TS 23758:2021 | IDF/RM 251:2021 Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products
  • ISO 16140-3:2021/CD Amd 1 Microbiology of the food chain-Method validation-Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory
  • ISO 16140-4:2020/CD Amd 2 Microbiology of the food chain-Method validation-Part 4: Protocol for method validation in a single laboratory
  • ISO/TS 23758:2021 Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products
  • ISO 16140-4:2020 Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory
  • ISO 16140-4:2020/DAmd 1 Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory — Amendment 1: Validation of a larger test portion size for qualitative methods
  • ISO 12828-2:2016 Validation methods for fire gas analyses - Part 2: Intralaboratory validation of quantification methods
  • ISO/DIS 16140-7 Microbiology of the food chain — Method validation — Part 7: Protocol for the validation of identification methods of microorganisms
  • ISO/CD TS 12828-3:2024 Validation method for fire gas analysis
  • ISO 16140-4:2020/CD Amd 1 Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory — Amendment 1: Annex H - Validation of larger test portion size for qualitative methods
  • ISO 16140-2:2016 Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method

Association Francaise de Normalisation

  • NF S93-100*NF EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods
  • FD X30-024:2019 Guide for undertaking verification assignments as defined in Article L. 225-102-1 of the Commercial Code
  • NF EN ISO 20072:2013 Verification of the design of an aerosol drug delivery device - Requirements and test methods
  • XP CEN ISO/TS 23758:2021 Guidelines for the validation of qualitative methods for screening for veterinary drug residues in milk and dairy products
  • NF ISO 12828-2:2020 Validation method for fire gas analyzes - Part 2: intralaboratory validation of quantification methods
  • XP V04-551*XP CEN ISO/TS 23758:2021 Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products
  • NF EN ISO 16140-3:2021 Microbiology of the food chain - Validation of methods - Part 3: protocol for the verification in a single laboratory of validated reference methods and alternative methods
  • NF EN ISO 16140-4:2020 Microbiology of the food chain - Method validation - Part 4: protocol for method validation in a single laboratory
  • NF X65-040-2*NF ISO 12828-2:2020 Validation method for fire gas analysis - Part 2 : Intralaboratory validation of quantification methods
  • NF V08-103-5*NF EN ISO 16140-5:2020 Microbiology of the food chain - Method validation - Part 4 : protocol for method validation in a single laboratory
  • NF V08-103-4*NF EN ISO 16140-4:2020 Microbiology of the food chain - Method validation - Part 4 : protocol for method validation in a single laboratory
  • NF V08-103-3*NF EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3 : protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
  • NF EN ISO 16140-2:2016 Microbiology of the food chain - Validation of methods - Part 2: protocol for the validation of alternative (commercial) methods compared to a reference method

Danish Standards Foundation

  • DS/EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods
  • DS/EN 13631-10:2004 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation
  • DS/ISO/TS 23758:2021 Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products
  • DS/ISO 16140-3:2021 Microbiology of the food chain — Method validation — Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory
  • DS/EN ISO 16140-3:2021 Microbiology of the food chain – Method validation – Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)

Japanese Industrial Standards Committee (JISC)

Lithuanian Standards Office

  • LST EN 13631-10-2004 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation
  • LST EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
  • LST EN ISO 20072:2011 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
  • LST EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
  • LST EN ISO 16140-4:2020 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)

British Standards Institution (BSI)

  • BS EN ISO 20072:2013 Aerosol drug delivery device design verification. Requirements and test methods
  • BS EN ISO 20072:2010 Aerosol drug delivery device design verification. Requirements and test methods
  • BS ISO 12828-2:2016 Validation methods for fire gas analyses. Intralaboratory validation of quantification methods
  • PD CEN ISO/TS 23758:2021 Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products
  • BS EN ISO 16140-3:2021 Microbiology of the food chain. Method validation. Protocol for the verification of reference methods and validated alternative methods in a single laboratory
  • BS EN ISO 16140-2:2016 Microbiology of the food chain. Method validation. Protocol for the validation of alternative (proprietary) methods against a reference method
  • BS ISO 15022-2:1999 Securities. Scheme for messages (data field dictionary) - Maintenance of the data field dictionary and catalogue of messages
  • BS PD CEN ISO/TS 23758:2021 Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products
  • BS EN ISO 16140-4:2020 Microbiology of the food chain. Method validation - Protocol for method validation in a single laboratory
  • BS EN ISO 16140-5:2020 Microbiology of the food chain. Method validation - Protocol for factorial interlaboratory validation for nonproprietary methods
  • BS IEC 62530-2:2021 SystemVerilog. Universal Verification Methodology Language Reference Manual
  • 21/30423811 DC BS EN 13631-10. Explosives for civil uses. Explosives - Part 10. Method for the verification of the means of initiation of explosives

AENOR

  • UNE-EN 13631-10:2004 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation
  • UNE-EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)

KR-KS

  • KS P ISO 20072-2021 Aerosol drug delivery device design verification —Requirements and test methods

Korean Agency for Technology and Standards (KATS)

SCC

  • DANSK DS/EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods
  • 07/30145258 DC BS ISO 20072. Aerosol drug delivery devices design verification. Requirements and test methods
  • AENOR UNE-EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
  • NS-EN ISO 20072:2013 Aerosol drug delivery device design verification — Requirements and test methods (ISO 20072:2009)
  • NS-EN ISO 20072:2010 Aerosol drug delivery device design verification — Requirements and test methods (ISO 20072:2009)
  • NS-EN 13631-10:2003 Explosives for civil uses — High explosives — Part 10: Method for the verification of the means of initiation
  • DANSK DS/EN 13631-10:2004 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation
  • DANSK DS/ISO 12828-2:2016 Validation methods for fire gas analyses -- Part 2: Intralaboratory validation of quantification methods
  • DANSK DS/ISO 16140-3:2021 Microbiology of the food chain — Method validation — Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory
  • DANSK DS/ISO/TS 23758:2021 Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products
  • DANSK DS/ISO 16140-4:2020 Microbiology of the food chain – Method validation – Part 4: Protocol for method validation in a single laboratory
  • BS 1610-1:1950 Verification of testing machines. Methods of load verification verification tensile and compression testing
  • DIN EN ISO 20072 E:2013 Draft Document - Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009); German version EN ISO 20072:2013
  • DANSK DS/EN ISO 16140-3:2021 Microbiology of the food chain – Method validation – Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
  • NS-EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
  • SN-CEN Guide 13:2008 Validation of environmental test methods
  • BS 5649-8:1982 Lighting columns-Method for verification of structural design by testing
  • BS 7597:1992 Method of test for cone proof loading on nuts
  • DANSK DS/CEN/TS 16800:2021 Guideline for the validation of physico-chemical analytical methods
  • DIN CEN/TS 16800 E:2014 Draft Document - Guideline for the validation of analytical methods; German version FprCEN/TS 16800:2014

German Institute for Standardization

  • DIN EN ISO 20072:2013-10 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009); German version EN ISO 20072:2013
  • DIN EN 13631-10:2004-02 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation; German version EN 13631-10:2003 / Note: To be replaced by DIN EN 13631-10 (2021-05).
  • DIN CEN ISO/TS 23758:2022-02 Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products (ISO/TS 23758:2021); German version CEN ISO/TS 23758:2021
  • DIN EN ISO 16140-3:2021-06 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021); German version EN ISO 16140-3:2021
  • DIN EN ISO 16140-4:2020-12 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020); German version EN ISO 16140-4:2020
  • DIN EN ISO 20072:2011 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009); German version EN ISO 20072:2010
  • DIN EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009); German version EN ISO 20072:2013

GSO

  • GSO ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods
  • BH GSO ISO/TS 23758:2023 Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products
  • GSO ISO/TS 23758:2023 Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products
  • BH GSO ISO 12828-2:2022 Validation method for fire gas analysis — Part 2: Intralaboratory validation of quantification methods
  • GSO ISO 12828-2:2021 Validation method for fire gas analysis — Part 2: Intralaboratory validation of quantification methods
  • OS GSO 1637:2002 Methods for load verification of tensile testing machines
  • GSO 95:1987 Method of Verification of Percision Balances
  • OS GSO 95:1987 Method of Verification of Percision Balances
  • GSO ISO 16730:2013 Fire safety engineering -- Assessment, verification and validation of calculation methods

VN-TCVN

  • TCVN 6331-1997 Determination of loss on drying at 120oC for 16 hours (United states phamacopolia method)

CZ-CSN

CU-NC

  • NC 90-14-01-1985 Metrologlcal Assurance. Working Resistcince Thermometers. Verificatlon Methods and Means
  • NC 90-11-13-1987 Metrological Assurance. Installations to Verify Clocks. Methods and Means of Verification
  • NC 90-03-01-1986 Metrological Assurance Square and Bar Levels Verification Methods and Means
  • NC 90-04-20-1987 Metrological Assurance. Picnometers. Methods and Means of Verification
  • NC 90-15-26-1984 Metrological Assurance. lnductance Measures. Verificatlon Methods and Means
  • NC 90-03-07-1987 Metrological Assurance. Micrometric Levels. Methods and Means of Verification

IT-UNI

  • UNI CEN ISO/TS 23758:2021 Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products

ES-UNE

  • UNE-EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
  • UNE-EN ISO 16140-4:2021 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)
  • UNE-CEN GUIA 13:2010 IN Validation of environmental test methods

ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc.

ANSI - American National Standards Institute

  • X3/TR-11-1992 Information Resource Dictionary System (IRDS) Support for Naming Convention Verification (NCV)

RU-GOST R

  • GOST R 57639-2017 Fire safety engineering. Validation and verification of calculation methods
  • GOST 25754-1983 Agricultural animals. Methods of laboratory diagnostics of classical pig-plague
  • GOST 12441-1966 Horisontal length comparators. Methods and means for verification

IN-BIS

  • IS 1828-1975 Tensile testing machine load verification method
  • IS 1754-1968 Verification method of Vickers hardness testing machine

American National Standards Institute (ANSI)

PL-PKN

  • PN-EN ISO 16140-3-2021-07 E Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
  • PN-EN ISO 16140-4-2021-01 E Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)

SAE - SAE International

Society of Automotive Engineers (SAE)

AT-ON

  • OENORM EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)
  • OENORM EN ISO 16140-4:2021 Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)
  • ONR CEN ISO/TS 23758:2021 Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products (ISO/DTS 23758:2021)

DIN

  • DIN EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)

CH-SNV

  • SN EN ISO 16140-3:2021 Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021)

Standard Association of Australia (SAA)

  • AS 16140.3:2022 Microbiology of the food chain — Method validation, Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021, MOD)

American Society of Quality Control (ASQC)

  • ASQ D61070-1997 Compliance Test Procedures for Steady-State Availability (T82E)

American Society for Testing and Materials (ASTM)

  • ASTM E4-79 Standard Methods of Load Verification Of Testing Machines