Pharmacopoeia method validation scope

Pharmacopoeia method validation scope, Total:179 items.

The international standard classification for "Pharmacopoeia method validation scope" includes: Protection against dangerous goods , Optical equipment , Metrology and measurement in general , Tobacco, tobacco products and related equipment .

The Chinese standard classification for "Pharmacopoeia method validation scope" includes: Marking, packaging, transport and storage in general , Optical instrument in general , Industrial automation and control device in general , Tobacco .

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

工业和信息化部

JB/T 14409-2022 Test methods of melting temperature range for brazing filler metal and solder

Professional Standard - Agriculture

343药典四部-2020 9000 Guidelines 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
1837药典一部-2010 Appendix XVIII E Guidelines for Validation of Alternative Methods for Microbiological Testing of Pharmaceutical Products
362药典三部-2020 Guideline 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
2408药典二部-2010 Appendix XXIX A Guidelines for Validation of Analytical Methods for Drug Quality Standards
2421药典二部-2010 Appendix XXIX O Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
SN/T 5490-2023 Guidelines for verificationof technical specificationsof Customs
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
331药典三部-2015 Technical Guideline 9201 General Guidelines for the Validation of Alternative Methods for Microbiological Testing of Drugs 216
324药典四部-2015 9000 Guidelines 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs
317药典四部-2015 9000 Guiding Principles 9101 Guiding Principles for Validation of Analytical Methods for Pharmaceutical Quality Standards
882兽药典一部-2015 Appendix Contents 9000 Guidelines 9201 Guidelines for Validation of Alternative Methods for Microbiological Testing of Veterinary Drugs
289药典三部-2010 Appendix ⅩVII ⅩVIB Guidelines for Validation of Alternative Methods for Microbiological Testing of Drugs

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

Professional Standard - Railway

TB/T 2536-1995 Test method for constant power speed range of diesel locomotive

Inner Mongolia Provincial Standard of the People's Republic of China

DB15/T 916-2015 Management specification for verification of pharmaceutical logistics facilities and equipment

Shanxi Provincial Standard of the People's Republic of China

DB14/T 2283-2021 Specifications for performance verification of pharmaceutical cold chain storage and transportation facilities for pharmaceutical business enterprises
DB14/T 2798-2023 Specification for verification of chemical analysis methods in testing laboratories

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

GB/T 12085.1-1989 Optics and optical instruments--Environmental test methods--Definitions extent of testing
GB/T 12085.1-2022 Optics and photonics—Environmental test methods—Part 11:Mould growth
GB/T 21781-2008 Test methods for melting point and melting range of chemical products - Capillary tube method
GB/T 12085.1-2010 Optics and optical instruments - Environmental test methods - Part 1:Definitions extent of testing

Professional Standard - Machinery

JB/T 5164-1991 Electric fence pulser test method
JB/T 9233.10-1999 General methods of testing the performance of industrial process measurement and control instruments Overrange effect
JB/T 7138.4-1993 Test method for braided net fence

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

GJB 772.203-1989 Explosives test method 75℃ heating test
GJB 772A-1997 Explosive test method
GJB 770A-1997 Propellant test method
GJB 772.205-1989 Explosives test methods Fire and Explosives Vacuum Stability Test

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

GJB 770B-2005 Test method of propellant

Group Standards of the People's Republic of China

T/BLTJBX 36-2021 Specifications for performance verification of pharmaceutical cold chain storage and transportation facilities for pharmaceutical business enterprises
T/HNCAA 027-2021 Verification of inspection and testing standard methods

Hebei Provincial Standard of the People's Republic of China

DB13/T 157.6-1993 Construction acceptance method of "Waishanzhuan" project

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 23223-2019 Test method of pesticide efficacy in tobacco field

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 18063-2:2021 Rough-terrain trucks - Visibility test methods and their verification - Part 2: Slewing rough-terrain variable-reach trucks (ISO 18063-2:2021)
EN 13087-6:2012 Protective helmets - Test methods - Part 6: Field of vision
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)

VN-TCVN

TCVN 4382-1986 Measuring equipments.Verification schedule.Scope and layout
TCVN 6331-1997 Determination of loss on drying at 120oC for 16 hours (United states phamacopolia method)

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

Japanese Industrial Standards Committee (JISC)

JIS A 1221:2002 Method for Swedish weight sounding test
JIS A 1221:2013 Method for Swedish weight sounding test
JIS A 1221:1995 Method for Swedish weight sounding test
JIS K 0064:1992 Test methods for melting point and melting range of chemical products
JIS A 1216:2009 Method for unconfined compression test of soils
JIS Z 3198-1:2014 Test methods for lead-free solders.Part 1: Methods for measuring of melting temperature ranges
JIS Z 3198-1:2003 Test methods for lead-free solders -- Part 1: Methods for measuring of melting temperature ranges
JIS K 4810:2001 Testing methods of explosives
JIS K 4810:1996 Testing methods of explosives

International Organization for Standardization (ISO)

ISO 20072:2009 Aerosol drug delivery device design verification - Requirements and test methods
ISO 18063-2:2021 Rough-terrain trucks - Visibility test methods and their verification - Part 2: Slewing rough-terrain variable-reach trucks
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/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/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

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/EN 13124-2:2004 Windows, doors and shutters - Explosion resistance - Test method - Part 2: Range test
DS/ISO 16140-3:2021 Microbiology of the food chain â€” Method validation â€” Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory
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

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 EN ISO 18063-2:2021 All-terrain trucks - Visibility test methods and their verification - Part 2: rotating all-terrain trucks with variable reach
NF P20-543*NF EN 13124-2:2004 Windows, doors and shutters - Explosion resistance - Test method - Part 2 : range test.
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

British Standards Institution (BSI)

BS EN ISO 18063-2:2021 Rough-terrain trucks. Visibility test methods and their verification. Slewing rough-terrain variable-reach trucks
BS EN ISO 20072:2010 Aerosol drug delivery device design verification. Requirements and test methods
BS EN ISO 20072:2013 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
BS ISO 9022-1:2012 Optics and photonics. Environmental test methods. Definitions, extent of testing
BS EN 12227-2:1999 Playpens for domestic use - Test methods
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
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
PD IEC/TR 62935:2016 Measurement methods. High dynamic range video
BS PD IEC/TR 62935:2016 Measurement methods. High dynamic range video
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

American Society for Testing and Materials (ASTM)

ASTM D6352-19e1 Standard Test Method for Boiling Range Distribution of Petroleum Distillates in Boiling Range from 174 °C to 700 °C by Gas Chromatography
ASTM D1519-95(2000) Standard Test Method for Rubber Chemicals-Melting Range
ASTM E2938-15 Standard Test Method for Evaluating the Relative-Range Measurement Performance of 3D Imaging Systems in the Medium Range
ASTM D1519-95(2009) Standard Test Method for Rubber Chemicals-Melting Range
ASTM D1519-95(2004)e1 Standard Test Method for Rubber Chemicals-Melting Range
ASTM D1519-95(2009)e1 Standard Test Method for Rubber Chemicals-Melting Range
ASTM D6352-14 Standard Test Method for Boiling Range Distribution of Petroleum Distillates in Boiling Range from 174 °C to 700 °C by Gas Chromatography
ASTM D6352-04(2009) Standard Test Method for Boiling Range Distribution of Petroleum Distillates in Boiling Range from 174 to 700176;C by Gas Chromatography
ASTM D7213-23 Standard Test Method for Boiling Range Distribution of Petroleum Distillates in the Boiling Range from 100 °C to 615 °C by Gas Chromatography
ASTM D6352-02 Standard Test Method for Boiling Range Distribution of Petroleum Distillates in Boiling Range from 174 to 700176C by Gas Chromatography
ASTM D6352-03 Standard Test Method for Boiling Range Distribution of Petroleum Distillates in Boiling Range from 174 to 700176;C by Gas Chromatography
ASTM D2265-94a Standard Test Method for Dropping Point of Lubricating Grease Over Wide Temperature Range
ASTM D1519-95(2014) Standard Test Methods for Rubber Chemicals—Determination of Melting Range
ASTM D2265-06 Standard Test Method for Dropping Point of Lubricating Grease Over Wide Temperature Range
ASTM D2265-06(2014) Standard Test Method for Dropping Point of Lubricating Grease Over Wide Temperature Range
ASTM D6352-04e1 Standard Test Method for Boiling Range Distribution of Petroleum Distillates in Boiling Range from 174 to 700176;C by Gas Chromatography
ASTM D2265-00 Standard Test Method for Dropping Point of Lubricating Grease Over Wide Temperature Range
ASTM D1078-11(2019) Standard Test Method for Distillation Range of Volatile Organic Liquids
ASTM D2265-15 Standard Test Method for Dropping Point of Lubricating Grease Over Wide Temperature Range
ASTM D2265-22 Standard Test Method for Dropping Point of Lubricating Grease Over Wide Temperature Range
ASTM D7213-14 Standard Test Method for Boiling Range Distribution of Petroleum Distillates in the Boiling Range from 100 °C to 615 °C by Gas Chromatography
ASTM D6352-98 Standard Test Method for Boiling Range Distribution of Petroleum Distillates in Boiling Range from 174 to 700176C by Gas Chromatography
ASTM D6352-19 Standard Test Method for Boiling Range Distribution of Petroleum Distillates in Boiling Range from 174 ℃ to 700 ℃ by Gas Chromatography
ASTM D6352-15 Standard Test Method for Boiling Range Distribution of Petroleum Distillates in Boiling Range from 174&x2009&xb0C to 700&x2009&xb0C by Gas Chromatography
ASTM D7398-23 Standard Test Method for Boiling Range Distribution of Fatty Acid Methyl Esters (FAME) in the Boiling Range from 100 °C to 615 °C by Gas Chromatography
ASTM D1519-95(2023) Standard Test Methods for Rubber Chemicals—Determination of Melting Range
ASTM D7213-15 Standard Test Method for Boiling Range Distribution of Petroleum Distillates in the Boiling Range from 100&x2009&xb0C to 615&x2009&xb0C by Gas Chromatography
ASTM D7398-07 Standard Test Method for Boiling Range Distribution of Fatty Acid Methyl Esters (FAME) in the Boiling Range from 100 to 615C by Gas Chromatography
ASTM D7398-21 Standard Test Method for Boiling Range Distribution of Fatty Acid Methyl Esters (FAME) in the Boiling Range from 100 °C to 615 °C by Gas Chromatography
ASTM D1519-95(2019) Standard Test Methods for Rubber Chemicals—Determination of Melting Range

RU-GOST R

GOST 8.322-1978 State system for ensuring the uniformity of measurements. Measuring signal generators. Methods and means for verification within the range of 0.03-17.44 GHz
GOST R 8.805-2012 State system for ensuring the uniformity of measurements. State verification schedule for means measuring electric field intensity within the frequency range from 0,0003 to 2500 MHz
GOST R 8.808-2012 State system for ensuring the uniformity of measurements. State verification schedule for means measuring magnetic field intensity within the frequency range from 0,000005 to 1000 MHz
GOST 12637-1967 High frequency magnet malleable materials. Testing methods at the range from 200 to 2000 mc

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 13124-2-2004 Windows, doors and shutters - Explosion resistance - Test method - Part 2: Range test

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 13124-2:2004 Windows, doors and shutters - Explosion resistance - Test method - Part 2: Range test
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
KS V 8890-2019(2024) Dynamic range measurement test procedure of frequency analysis system for ships
KS M ISO 6299-2003(2023) Petroleum products - Dropping point test method for lubricating grease (wide temperature range)

Korean Agency for Technology and Standards (KATS)

KS P ISO 20072:2021 Aerosol drug delivery device design verification —Requirements and test methods
KS K 0592-2016 Test method for water resistance of coated cloth：High range, hydrostatic pressure method
KS M 4802-1983 Testing methods of explosives
KS K 0592-2022 Test method for water resistance of coated fabrics: High range,hydrostatic pressure method
KS M 4802-2006(2016) Testing methods of explosives
KS M 4802-2006(2021) Testing methods of explosives

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 ISO 340:2007 Conveyor belts - Laboratory scale flammability characteristics - Requirements and test method (ISO 340:2004); English version of DIN EN ISO 340:2007-06
DIN EN 13087-6:2012 Protective helmets - Test methods - Part 6: Field of vision; German version EN 13087-6:2012
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

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
AASHTO T 67-2005 Standard Method of Test for Standard Practices for Force Verification of Testing Machines
BS ISO 9022-1:1994 Optics and optical instruments. Environmental test methods-Definitions, extent of testing
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 13124-2:2004 Windows, doors and shutters — Explosion resistance — Test method — Part 2: Range test
NS-EN ISO 20072:2010 Aerosol drug delivery device design verification — Requirements and test methods (ISO 20072:2009)
DANSK DS/EN 13631-10:2004 Explosives for civil uses - High explosives - Part 10: Method for the verification of the means of initiation
NS-EN 13631-10:2003 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 â€” Method validation â€” Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory
DANSK DS/IEC TR 62935:2016 Measurement methods – High dynamic range video
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

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
GSO ISO 12828-2:2021 Validation method for fire gas analysis — Part 2: Intralaboratory validation of quantification methods

CEN - European Committee for Standardization

EN 13087-6:2000 Protective Helmets - Test Methods - Part 6: Field of Vision (Incorporates Amendment A1: 2001)

CZ-CSN

CSN 25 3308-1980 Block gauges. Methods of verification

PL-PKN

PN C05011 ArkusZ01-1971 Test methods of conveyer belts General re?uirements and scope of the standard
PN A79528-01-1992 Spirit (ethyl aJcohol) Methods of tests Rang? of tests and genera? principles
PN C82055 ArkusZ00-1974 Test methads oi pressed carfoom praduobs Genera? re?uiremenits and stop? of the standard

US-CFR-file

CFR 46-189.25-10-2014 Shipping. Part189:Inspection and certification. Section189.25–10:Scope of inspection.

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

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

International Electrotechnical Commission (IEC)

IEC TR 62935:2016 Measurement methods - High dynamic range video

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)

American National Standards Institute （ANSI)

ANSI/ASTM D7398:2007 Test Method for the Boiling Range Distribution of Fatty Acid Methyl Esters (fame) in the Boiling Range from 100 to 615 C by Gas Chromatography

GOST

GOST R 8.763-2011 State system for ensuring the uniformity of measurements. State verification schedule for measuring instruments of length in the range from 1·10-9 to 50 m and wavelength in the range from 0, 2 to 50 µm

AT-ON

ONORM S 5280-1-1998 Radon - Measuring methods and their r?nge of applications

ETSI - European Telecommunications Standards Institute

EG 201 015-2012 Methods for Testing and Specification (MTS); Standards engineering process; A Handbook of validation methods (V2.1.1)

GOSTR

GOST 8.536-1985 State system for ensuring the uniformity of measurements. State verification schedule for means measuring of the coating thickness in the range of 1 to 20000 um

Others: Method Validation Scope,Method Validation Scope,scope in method validation,Method Validation Scope,Scope of Method Validation