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

Dissolution Testing

Pharmaceutical labs consider dissolution testing to be one of the critical ...

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Elemental Impurities Testing

Elemental Impurities in drug products can arise from several sources, inclu ...

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Extractables & Leachables

Pharmaceutical laboratories must evaluate the interactions between packagin ...

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Pharmaceutical Raw Material Identification

The analysis of all incoming pharmaceutical raw materials is a key part of ...

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Drug Substance Assay

Inspections of drug substances are designed to confirm manufacturing plants ...

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Drug Product Assay

An extensive set of analytical testing and acceptance criteria is applicabl ...

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Excipients Characterization

The quality of excipients is extremely important since 90% of medicines are ...

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Residual Solvents

The synthesis of active pharmaceutical ingredients (API) may require multip ...

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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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