All standards
Browse the regulatory and quality references that map to your categories.
All standards
Browse the regulatory and quality references that map to your categories.
ISO 15189
ISO 15189 is the international standard defining quality and competence requirements for medical laboratories. Published by ISO, it covers quality management, technical competence, risk management and point-of-care testing (POCT). The current edition is ISO 15189:2022, which replaced ISO 15189:2012.
ASME BPE
ASME BPE is the international standard defining design, materials, fabrication, inspection and certification requirements for bioprocessing equipment. Published by ASME, it applies to the biopharmaceutical, pharmaceutical and personal care industries where a defined level of purity and bioburden control is required. The current edition is ASME BPE-2024.
ISO 4490:2018
Metallic powders: Determination of flow rate by means of a calibrated funnel (Hall flowmeter).
ASTM D6128
Method for powder flow testing using shear analysis.
ISO 4324:1997
Aggregates for mortar: Determination of the flow rate of mortar.
ASTM D6393
ASTM D6393 is the standard test method for bulk solids characterization by Carr Indices. It defines apparatus and procedures for eight measurements and two calculations describing the behaviour of powders and granular materials. The current version is ASTM D6393/D6393M-21.
ISO 6014:1986
Food supplements: Starch – Determination of flow rate.
ASTM standards for powder flow
Set of ASTM standards for powder flow characterization.
ISO 6611-2:2000
Refractory powders: Determination of flow rate by rotary funnel.
cGMP
Current Good Manufacturing Practices for the pharmaceutical industry.
EN 17141:2020
EN 17141:2020 is the European standard for biocontamination control in cleanrooms and associated controlled environments. Published by CEN in August 2020, it consolidates the content of both parts of the ISO 14698 series, which it superseded as a CEN standard, and adds risk assessment, microbiological measurement methods and sector specific annexes.
EP 2.2.44
EP 2.2.44 is the European Pharmacopoeia general chapter covering determination of total organic carbon (TOC) in water for pharmaceutical use. It prescribes no single method: it defines the procedures for qualifying the chosen method and interpreting results in limit tests. The nominal limit is 0.50 mg/L of carbon.
EP 2.9.19
EP 2.9.19 is the European Pharmacopoeia general chapter covering particulate contamination by sub-visible particles in injections and infusions. It defines two procedures: Method 1, light obscuration particle count, and Method 2, microscopic particle count. The chapter is harmonised with USP 788 and JP 6.07.
EP 2.9.31
European standard for particle size analysis by diffraction.
EP 2.9.34
European method for powder flow testing.
EP 2.9.36
European standard for assessing powder flow properties.
EU GMP Annex 1
Requirements for aseptic manufacturing and controlled environments.
ISO 13099-1:2012
Guide for electrophoretic mobility measurement.
ISO 13099-2:2012
Procedures for zeta potential measurement.
ISO 13319-1:2021
Method for determining particle density in liquids.
ISO 13320-1:2020
Standard for particle size analysis by laser diffraction.
ISO 14644-1:2015
ISO 14644-1:2015 classifies air cleanliness in cleanrooms and clean zones according to the concentration of airborne particles.
ISO 14698-1
Biocontamination control in controlled environments.
ISO 19403 series
Methods for surface energy and contact angle measurement.
ISO 19403-1 até ISO 19403-7
Part of ISO series for wettability and surface tension characterization.
ISO 21501-3
Specification for liquid particle counters.
ISO 21501-4:2018
ISO 21501-4:2018 defines calibration and verification methods for light scattering airborne particle counters used in clean spaces.
ISO 22412:2017
Standard for nanoparticle size measurement via DLS.
ISO 9001:2015
ISO 9001:2015 defines internationally recognized requirements for implementing, maintaining and continually improving a quality management system.
JP <11>
Japanese method for particle analysis in injectable drugs.
JP <24>
Japanese method for physicochemical testing of solutions.
KP <52>
Korean standard for particle counting in injectables.
USP <1174>
Guidance for powder flow and properties testing.
USP <429>
USP method for particle size analysis.
USP <643>
Total organic carbon test in water.
USP <645>
Electrical conductivity test for purified water.
USP <787>
Method for particle analysis in small-volume injectables.
USP <788>
Method for particle counting in parenteral solutions.
USP <789>
Standard for particle counting in ophthalmic solutions.
21 CFR Part 11
21 CFR Part 11 is the FDA regulation setting the criteria under which electronic records and electronic signatures are considered trustworthy and equivalent to paper records and handwritten signatures. It applies to records required by other FDA regulations (predicate rules) when kept in electronic form.
Validação FDA (sistemas de controle)
Validation requirements for automated systems under FDA.
ISO 15189
ASME BPE
ISO 4490:2018
ASTM D6128
ISO 4324:1997
ASTM D6393
ISO 6014:1986
ASTM standards for powder flow
ISO 6611-2:2000
cGMP
EN 17141:2020
EP 2.2.44
EP 2.9.19
EP 2.9.31
EP 2.9.34
EP 2.9.36
EU GMP Annex 1
ISO 13099-1:2012
ISO 13099-2:2012
ISO 13319-1:2021
ISO 13320-1:2020
ISO 14644-1:2015
ISO 14698-1
ISO 19403 series
ISO 19403-1 até ISO 19403-7
ISO 21501-3
ISO 21501-4:2018
ISO 22412:2017
ISO 9001:2015
JP <11>
JP <24>
KP <52>
USP <1174>
USP <429>
USP <643>
USP <645>
USP <787>
USP <788>
USP <789>
21 CFR Part 11
Validação FDA (sistemas de controle)
Stay in the loop
Get updates, articles and news by email.