Quality
光谱化学有正确的化学支持的质量控制.
我们的质量控制团队由30多名化学家和技术人员组成,每年在我们的ISO 9001-2015内部进行000次测试, certified testing facilities in California, New Jersey and Shanghai. 这确保了制药和生物制药产品的安全成分.
Our New Brunswick, NJ Corporate headquarters contains 200,000 sq ft of manufacturing, laboratory and warehousing space. 该工厂具有CFR 210/211 cGMP生物制药标准包装能力，并已在FDA注册. 该设施也是我们的药房部门，光谱药房产品的所在地.
With over 125,000 sq ft of manufacturing, laboratory and warehousing space, our ISO 9001-2015-certified Gardena, CA facility is also FDA and DEA registered.
在我们的质量控制中例行进行的测试 laboratories:
Instrumental Analysis
- Atomic Absorption
- FTIR
- Fluorescence
- Gas Chromatography
- HPLC/UHPLC
- ICP/MS (Trace elemental analysis: compliance with USP <232>/<233>)
- Potentiometric Measurements (pH and ISE)
- More: Proteomic Imaging, Refractive Index, Rotational Viscosity, Specific and Optical Rotation, UV/Vis Spectroscopy, Melting Point, Karl Fischer Titration
Microbial Testing (Biopharma)
- Differentiate Bacterial Colonies
- DNase
- RNase
- Protease
- Endotoxin by LAL
- Total Plate Count
- Yeast and Mold
- Specified Organisms
Wet Chemistry
- Residue on Ignition
- Loss on Drying
- Heavy Metals
- Iodine Value
- Residue on Evaporation
- Colorimetric Analysis
- Gravimetric Analysis
- Solvent Extraction Techniques
- 滴定法(酸度法、络合法和氧化还原法)
科学文献-远远超过CofA
频谱提供超过600专业准备的档案 可下载的USP化学品. 该文件对药品制造商至关重要, 以及需要对生物负荷进行特殊测试/认证的特定产品, elemental impurities or endotoxins. Spectrum提供十多种标准测试和认证，并可根据要求提供定制测试. 在试验和扩大生产阶段提供下游生产化学品和材料的相关文件，通过避免停机时间，降低了制造商的财务和市场风险, 或者产品在开发过程中的采购问题.
广泛的科学文件和质量控制支持
- Product Specification
- Safety Data Sheet
- Manufacturing Process Flowchart
- 质量管理体系认证
- Product BSE/TSE Statement
- Product Allergen Statement
- Product Aflatoxin Statement
- General Label Information
- Product Certificate of Analysis Sample
- General Lot Numbering System Guidance
- Stability/Shelf Life Guidance
- Kosher and Halal Statements
使光谱化学成为您质量管理体系的一部分
Customer Needs
- Eliminate unpredictability
- Reduce reworks
- Speed time to market
- Prevent product inconsistency
- Ensure reliable performance
- Streamline product onboarding
- Address formulation-related questions
- Conduct audits and review audit reports
QC Program Delivery
- 文件化的过程和技术支持，以解决不符合问题
- 变更控制，产品规格管理，供应链透明度
- QA“票证”流程识别和解决供应商之间的文件或生产问题
- Lead time management
- Custom packaging
bioCERTIFIED™ Quality Management System & Chemicals
- 完整的批分析包括内毒素，生物负荷和元素杂质的测试
- 全面的法规和科学文件
- 变更控制，批量可追溯性和供应链透明度
- 广泛的产品广度和包装灵活性
质量问题:法规遵从性和审计
Spectrum一直在努力使遵从性尽可能简单. Customers seeking to purchase sensitive, 管制或管制物品将被要求提供适当的凭证. For some products, 我们将要求提供额外的预期用途信息，以满足监管或产品管理义务. 请尽快提供所需的信息和文件，帮助我们运送您的订单.
Spectrum Chemical为客户提供审核服务. 请冰球突破app下载的质量保证部门安排内部或虚拟审核.
Quality Assurance: quality_assurance@psincremodeling.com
USA / Canada: 1-800-772-8786
