PerkinElmer

药品生产QA/QC

当涉及到QA/QC时,我们提供一切来保持每一步的合规性,从我们的分析仪器到我们独特的OneSource服务和支持。当这些工具结合在一起时,它们将作为一个系统来创造安全、优质的产品,消费者可以信任,制药商也可以对其充满信心。

良好生产规范(GMP)不仅推动了公司内部的质量保证/质量控制,而且还指导了珀金埃尔默开发我们构建的技术、工具和流程,以确保您在持续生产合规产品的同时满足监管义务。

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Regulatory & Compliance

Helping our customers meet compliance in a regulated environment

Given today’s evolving and increasingly complex regulatory environments, a whole new mindset to auditing, moving away from traditional instrument validation approaches and concentrating on the data lifecycle to detect gaps or fraud in product development and quality control are critical to compliance.

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Drug Substance & Excipients

Ensuring purity & assuring compliance

In order to comply with GMP standards, including identification of incoming raw material testing, drug substance assay and excipient quality, you need the latest analytical tools and data to meet compliance.

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Drug Product

Mitigating risk while maximizing production

Drug product or finished dosage form (tablet, capsule, injectables) contains a drug substance and excipient. All drug products must be GMP compliant to be released for commercial use. PerkinElmer provides the tools you need to release safe and effective medicines giving the peace of mind you need when it comes to audits.

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Control of Impurities

Keeping impurities and compliance under control

The control of impurities is mandatory for both drug substance and drug product testing. QA/QC laboratories need to guarantee impurity levels are below the threshold established by regulatory authorities such as FDA, EMA, MHRA to ensure GMP compliance.

At PerkinElmer, we provide the tools you need for you to take control of your impurities testing.

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Stability Testing

Monitoring and measurement for shelf-life and storage

Typically, both drug substance and drug product are tested in at least two different storage conditions: long term ambient storage temperature and accelerated conditions predicting product stability at a long period of time.

To highlight its importance, ICH provides a dedicated section to Stability - at PerkinElmer, we provide the tools you need so you have your shelf-life and storage temperature under control.

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Explore Our Solutions

Dissolution Testing

Pharmaceutical labs consider dissolution testing to be one of the critical steps in the drug development process. It makes an impact at almost every step of the ...

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杂质分析

确保符合USP <232>/<233>和ICH Q3D要求(该标准制药监管政策有史以来最重大的修订)。 我们提供从样品制备、仪器检测的完整解决方案,确保完全符合USP <232> / <233>和ICH Q3D中的相关规定。

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Extractables & Leachables

Pharmaceutical laboratories must evaluate the interactions between packaging material and formulation, applying risk assessments defined on ICH Q9 guidelines to ...

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Pharmaceutical Raw Material Identification

The analysis of all incoming pharmaceutical raw materials is a key part of GMP compliance to guarantee safety and efficacy of a finished dosage form which is la ...

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Drug Substance Assay

Inspections of drug substances are designed to confirm manufacturing plants, as well as the quality control laboratory, follow CGMP regulations. An extensive se ...

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Drug Product Assay

An extensive set of analytical testing and acceptance criteria is applicable to drug products –including universal and specific test criteria established by ICH ...

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Excipients Characterization

The quality of excipients is extremely important since 90% of medicines are made up of them. When it comes to regulatory guidelines, there are several the indus ...

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Residual Solvents

The synthesis of active pharmaceutical ingredients (API) may require multiple reaction steps that produce undesirable reaction byproducts or utilize various sol ...

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Explore Our Instruments

色谱

无论您要面对怎样的的应用、技术和法规要求,我们都有色谱解决方案来解决您的分离和检测难题。 我们的多元化产品组合包括液相色谱仪(LC),液相色谱/质谱联用仪(LC/MS),气相色谱仪(GC),气相色谱/质谱联用仪(GC/MS)和Arnel-GC工程色谱系统。此外,我们提供最全面的样品前处理技术解决方案,其中包括一系列的自 ...

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原子光谱

如果您正在寻找世界领先的AA,ICP-OES,ICP-MS或汞分析系统,您已经到了正确的地方。 全世界数以万计的用户依靠PerkinElmer光谱仪快速、高效、轻松地从无机元素分析中获得准确的结果。无论哪种领域、应用或样品类型,我们都有相应的工具和专业知识可提供帮助 - 所有这些都是基于50多年来在原子光谱领域累积的前 ...

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分子光谱

复杂材料表征技术,总有一款适合您。我们拥有全面的分析解决方案,可以为各种的实验室提供理想的分子光谱仪器,包括紫外光谱,红外光谱及荧光光谱。 更高精度,确保获得更高的灵敏度 灵活的设计,满足不同尺寸的样品测试 多种采样附件可供选择 更短的样品配置时间 软件易学易用,提供专业的结果 作为红外光谱技术的业界先驱,我们在60年 ...

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热分析

使用我们全面的热分析仪器系列,提高热分析的精确度,灵敏度和性能。我们业界领先技术的应用包括: QA/QC应用 药物过程研究 聚合物研究 回收塑料的识别 包装材料的测定 纳米材料 涂料 复合材料 其他更多 仅供科学研究,非临床诊断用途。

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