PerkinElmer

Pharma & Biopharma 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 steps in the drug development process. It makes an impact at almost every step of the ...

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Elemental Impurities Testing

Elemental Impurities in drug products can arise from several sources, including interactions with processing equipment or container/closure systems, presence in ...

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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

Chromatography Instruments

Whatever your application, industry requirements or regulations, we have a breadth of solutions designed to solve your separation and detection challenges. Our ...

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Atomic Spectroscopy Instruments

If you're looking for world-leading AA, ICP-OES, ICP-MS, or mercury analysis systems, you've come to the right place. Tens of thousands of installations worldwi ...

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Molecular Spectroscopy Instruments

Characterize advanced complex materials on any budget. Our comprehensive portfolio of analytical solutions has the ideal molecular spectroscopy instruments for ...

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Thermal Analysis Instruments

Improve accuracy, sensitivity, and performance in thermal analysis using our comprehensive portfolio of instruments. Applications of our industry-leading techno ...

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Organic Elemental Analysis Instruments

For reliable elemental analysis and proven performance when analyzing carbon, hydrogen, nitrogen, sulfur, and oxygen (CHNS/O), we have the right solution for yo ...

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