№ lp_1_2_48884
File format: docx Character count: 6748 File size: 437 KB
This document provides detailed regulatory, compositional, and quality control information for excipients used in pharmaceutical products.
Year: 2020
Region / city: International
Subject: Pharmaceutical Excipients
Document Type: Regulatory Datasheet
Organization / Institution: International Pharmaceutical Excipients Council
Author: International Pharmaceutical Excipients Council
Target Audience: Manufacturers, Suppliers, Regulatory Bodies
Period of Validity: Not specified
Approval Date: Not specified
Date of Amendments: Not specified
Price: 8 / 10 USD
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Questionnaire for Excipient Nitrosamines Risk Evaluation Following EMA Requirement of 19 September 2019
Year: 2019
Subject: Nitrosamine risk assessment in pharmaceutical excipients
Document type: Questionnaire and technical guidance
Regulatory reference: European Medicines Agency nitrosamine review requirement
Related document: Information on nitrosamines for marketing authorization holders (EMA/189634/2019)
Note: Related document Questions and answers on Information on nitrosamines for marketing authorization holders (EMA/CHMP/428592/2019 Rev. 1)
Industry sector: Pharmaceutical manufacturing
Scope: Evaluation of nitrosamine formation risks in excipient manufacturing processes
Prepared for: Drug product manufacturers and Marketing Authorization Holders
Intended respondents: Excipient suppliers and manufacturers
Regulatory authorities referenced: European Medicines Agency, Health Canada, Therapeutic Goods Administration (Australia), Swissmedic
Key substances addressed: Nitrites, nitrates, nitrosamines, secondary and tertiary amines
Manufacturing aspects covered: Raw materials, intermediates, reagents, catalysts, solvents, water purification, recycled solvents, multipurpose equipment
Supporting content: Guidance on nitrosating agents, amine sources, contamination risks, acceptable intake determination, and purge assessment principles
Topics: TemplatesVersion 42020 Excipient