The International Council for Harmonisation
Business Services · Switzerland · 1-10 Employees
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Overview
Headquarters
Rte Pré-bois 20, Geneva, Geneva, 1215, S...Phone Number
+41 227107480Website
www.ich.orgRevenue
$6.1 MillionIndustry
ZI Rank: 1
Signal Type
Mar
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ZI Rank
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About The International Council for Harmonisation
The International Council for Harmonization (ICH) Guideline is intended to provide guidance regarding Good Manufacturing Practice (GMP) for the manufacturing of Active Pharmaceutical Ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess. This Guideline applies to the manufacture of APIs for use in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered by this guidance but should be performed in accordance with GMP guidelines for drug (medicinal) products as defined by local authorities.Explore more
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will be attending the FIREX International 2023 conference as an exhibitor. The event will occur from May 16 to May 18, 2023.
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will be attending the IFSEC International 2023 conference as an exhibitor. The event will occur from May 16 to May 18, 2023.
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will be attending the Facilities Show 2023 conference as an exhibitor. The event will occur from May 16 to May 18, 2023.
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The International Council for Harmonisation News & Media
Vulcan FHIR® Accelerator Connects CDISC, HL7, and ICH M11 in a Project to Digitize Exchange of Clinical Research Protocols
ANN ARBOR, Mich. & AUSTIN, Texas--(BUSINESS WIRE)-- #cleardataclearimpact--A structured, harmonized, digitized protocol accessible to the biopharmaceutical industry and to researchers in the care setting will enable transformations to improve clinical research. The project announced by HL7 Vulcan and CDISC will build on work products of ICH M11 to accelerate this vision. Vulcan is an HL7® FHIR Accelerator dedicated to connecting clinical and translational research to clinical care through Fast HSUCCESSFUL PASSING OF EU QP AUDIT ON TOT BIOPHARM'S COMMERCIAL PRODUCTION BASE FOR MONOCLONAL ANTIBODY DRUG SUBSTANCES AND ANTIBODY DRUG CONJUGATES
SUZHOU,China, Oct. 27, 2022 /PRNewswire/ -- TOT BIOPHARM International Company Limited (TOT BIOPHARM, Stock code: 1875.HK) has recently received a GMP compliance inspection report approved by a Qualified Person ("QP") in the European Union ("EU") in respect of the manufacturing facilities and associated quality systems of the Group's commercial production base for its self-developed HER2-targeted antibody drug conjugate ("ADC") candidate, TAA013. Pursuant to EudraLex Volume 4 regulations (EU GooAlto Ingredients, Inc. Receives Additional Medical and Pharmaceutical Ingredient Certifications at Pekin, Illinois Campus
SACRAMENTO, Calif., March 03, 2022 (GLOBE NEWSWIRE) -- Alto Ingredients, Inc. (NASDAQ: ALTO), a leading producer and distributor of specialty alcohols and essential ingredients, announced its Pekin, Illinois facility is now ICH Q7 and EXCiPACT Good Manufacturing Practices (GMP) certified.
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The International Council for Harmonization (ICH) Guideline is intended to provide guidance regarding Good Manufacturing Practice (GMP) for the manufacturing of Active Pharmaceutical Ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that the... Read More
