Quality

Quality

The quality of the chemical ingredients, 组成制药和生物制药产品的原料药和赋形剂对药物的整体成功至关重要. For over five decades, Spectrum Chemical已经积累了这方面的经验, 专业知识和质量体系以确保产品符合FDA或其他质量标准.

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.

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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 
Right

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



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@szjewellery.com

USA / Canada: 1-800-772-8786

Regulatory Compliance and Forms


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About Spectrum Chemical Mfg. Corp.

At Spectrum Chemical, 我们是一家经过认证的女性企业(WBE),在采购方面拥有50多年的专业知识, 质量控制测试和包装,以满足在高度管制的行业组织的需求.

超过250名员工在全球三个地区共同工作. We offer more than 45,000 chemicals in laboratory, scale-up and bulk quantities, as well as more than 60,000 supplies, equipment and PPE consumables. 我们总共代表250家制造商,服务于70个国家的120个行业.

我们知道,我们的产品只有经过分析测试和文件证明才是好的. 这就是为什么我们通过批次进行内部QC测试,以确保我们每个设施的质量,并提供广泛的法规和科学文件,以确保合规性. We also offer change control, 批次可追溯性和供应链透明度,消除不可预测性. Meanwhile, products are manufactured, 在fda注册和检查的设施中按照cGMP包装和储存.

凭借我们多样化的产品组合和对质量的不懈关注, 我们提供安全的供应,以尽量减少风险和原材料的变化, 并提供高度个性化的服务和实用的咨询,赢得您的信任和超越期望.

2023