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PerkinElmer

Pharma QA/QC

When it comes to QA/QC, we offer everything to stay compliant each step of the way, from our analytical instrumentation to our unique OneSource service and support. When these tools come together, they work as a system to create safe, quality products consumers can trust and pharmaceutical manufacturers can feel confident about.

Good Manufacturing Practice (GMP) not only drives the QA/QC inside your company, but it also guides PerkinElmer’s development of the technologies, tools and processes we build to assure you are meeting your regulatory obligations while you continuously manufacture compliant product.

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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

Analytical Chemistry Software

Solve problems in almost all areas of chemistry for all kinds of industries ...

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Consumables

Partner with us and give your laboratory the benefits of cutting-edge instr ...

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QA/QC Software

Organize all of the testing and results needed to control manufacturing pro ...

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Reference Materials

Accelerate the calibration verification of your materials characterization ...

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Explore Our Instruments

Chromatography Instruments

Whatever your application, industry requirements or regulations, we have a ...

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Atomic Spectroscopy Instruments

If you're looking for world-leading AA, ICP-OES, ICP-MS, or mercury analysi ...

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Molecular Spectroscopy Instruments

Characterize advanced complex materials on any budget. Our comprehensive po ...

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Thermal Analysis Instruments

Improve accuracy, sensitivity, and performance in thermal analysis using ou ...

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Organic Elemental Analysis Instruments

For reliable elemental analysis and proven performance when analyzing carbo ...

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