№ files_lp_4_process_3_074086
File format: docx
Character count: 7643
File size: 53 KB
Technical questionnaire and guidance document outlining regulatory-driven information collection and evaluation criteria for identifying potential nitrosamine formation risks in pharmaceutical excipient manufacturing processes following the 2019 EMA requirement.
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
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
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
Date:
12 May 2025
Document Number:
EMA/152360/2016 rev.1
Modules:
2.5, 2.7.1, 2.7.2, 2.7.3, 2.7.4, 5.3.x.x
Type:
Regulatory submission template
Purpose:
Clinical overview, biopharmaceutical studies, clinical pharmacology, efficacy, safety, CSR body, CSR appendices
Applicant/MAH:
Not specified
Regulatory Agency:
European Medicines Agency
Confidentiality Guidance:
Annex 3 of POLICY/0070
Period:
2025
Year:
Not specified
Region / Country:
Not specified
Subject:
Conflicts of Interest and Confidentiality
Document type:
Declaration form
Organization / Institution:
European Medicines Agency (EMA)
Intended audience:
EMA Experts, Patients involved in EMA activities
Sections included:
Personal Details, Declaration of Interests, Confidentiality Undertaking
Time frame for declaration:
Last 3 years and any executive/lead roles in career
Format:
Electronic completion
Year:
2024
Region / city:
Europe
Theme:
Health Technology Assessment, Medicinal Products
Document type:
Template
Organization:
European Medicines Agency (EMA), HTACG
Author:
Not specified
Target audience:
Health Technology Developers (HTD), European regulatory bodies
Period of validity:
Not specified
Date of approval:
28 November 2024
Date of revisions:
Not specified
Year:
2025/2026
Region / City:
West Dunbartonshire
Subject:
Education Maintenance Allowance (EMA)
Document Type:
Guide
Organization / Institution:
West Dunbartonshire Council
Author:
West Dunbartonshire Council
Target Audience:
Students eligible for EMA
Validity Period:
2025-2026
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2023
Region / City:
Europe
Topic:
Pharmaceutical Regulation
Document Type:
Position Paper
Organization / Institution:
EFPIA (European Federation of Pharmaceutical Industries and Associations)
Author:
EFPIA
Target Audience:
Regulatory authorities, pharmaceutical industry stakeholders
Effective Period:
Ongoing evaluation
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2025
Region / City:
United Kingdom
Topic:
Electromagnetic Activities Research and Development
Document Type:
Prior Information Notice (PIN) Questionnaire
Organization:
Defence Science and Technology Laboratory (Dstl)
Target Audience:
Industry, academia, and suitably qualified experienced personnel (SQEP)
Period of Implementation:
Up to 5 years starting January 2025
Purpose:
Collect market feedback and insights for future EMA S&T research collaboration and development
Focus Areas:
Integration and synchronisation of EMA, Generation after Next (GAN) Electromagnetic Attack capabilities
Governance:
Leadership Team from Dstl and supplier, Consultation Group, Delivery Group
Scope:
TRL 1-6, primarily TRL 1-4 research taskings
Collaboration Model:
EMA Accelerator (EMAA) with end-to-end task management and industry/academic involvement