ThescopeofgoodmanufacturingpracticesforAPIsasdescribedintheInternationalCouncilforHarmonisationofTechnicalRequirementsforPharmaceuticalsforHumanUse(ICH)guidelinesICHQ7—GoodManufacturingPracticeGuideforActivePharmaceuticalIngredientsandICHQ11—DevelopmentandManufactureofDrugSubstances(ChemicalEntitiesandBiotechnological/BiologicalEntiti...
A“startingmaterial”isarawmaterial,intermediate,oranactivepharmaceuticalingredientthatisusedintheproductionof—andincorporatedasasignificantstructuralfragmentinto—thedrugsubstance,asdescribedinthefollowingInternationalCouncilforHarmonisationofTechnicalRequirementsforPharmaceuticalsforHumanUseguidelines:ICHQ7—GoodManufacturingPracti...
This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. The report is complemented by a number of...
information could also be used for drug procurement purposes. Where the comparator pharmaceutical product is not clearly defined, criteria are suggested that are provided in a decision- tree format (see Figure 1). This permits the selection of a comparator pharmaceutical product. The guidelines on...
White Paper download: Requirements for USP <232> and USP <233> elemental impurities testing. Download now Brochure download: Elemental Analysis, Elemental Impurity Analysis USP 233 and USP 232 Services ICH Q3D Risk Assessment and Testing Trace Metals Testing for Pharmaceuticals Pharmaceutical Impurity Te...
APPROACHES FOR DEVELOPING COMPENDIAL STANDARDS FOR CANNABIS USP has a long history of developing quality standards for herbal medicines, either as pharmaceuticals or as dietary supplements. USP has state-of-the-art laboratories throughout the world, and global scientific expertise in the form of USP ...
Many pharmaceuticals are considered hazardous even in microscopic amounts. The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it damages DNA, causes cancer, contributes to infertility, harms a developing fetus, causes developmental abnormalities or cause...
Spectroscopy Solutions for Pharmaceuticals: Confidence in Compliance to USP <857> Using the Agilent Cary 60 UV-Vis Spectrophotometer White Paper Introduction UV-Vis spectroscopy is one of the most commonly used analytical techniques in clinical chemistry, pharmaceutical research, and quality control/...
Citation:When referring to this article, please cite it as D. Schmidt, et al., “USP Publishes Monoclonal Antibody Guidelines,”Pharmaceutical Technology39(3) 2015. Vaccine Development and Production Challenges Manufacturers Europe Strives for a More Efficient Generic-Drug Approval Framework ...
Of particular note for pharma packaging regulations is USP 661, which establishes related tests and acceptance criteria for packaging containing pharmaceuticals, biologics, dietary supplements, and devices. In 2020, USP 661 was determined to be too vague and required revisions to make testing more ...