Optimize Pharmaceutical Workflows with Advanced Analytical Solutions
In the highly regulated pharmaceutical industry, ensuring compliance for every drug substance and, the product relies on establishing Identity & Purity. Our comprehensive portfolio of products and services supports efficient and accurate pharmaceutical workflows. Our advanced analytical instruments, including Spectroscopy, Chromatography and Thermal Analysis tools, offer precise and reliable results essential for thorough analysis - from research, development, and manufacturing to packaging.
Ensuring compliance with regulatory requirements is crucial. Our software solutions are designed to meet 21 CFR Part 11 standards, where applicable, providing secure and efficient data management and instrument control. Enhance your laboratory’s efficiency and productivity with our tailored workflow optimization services, offering expert consultation and support to meet your operational goals. Additionally, maintain peak performance with our wide range of high-quality consumables and accessories.
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.
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.
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.
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.
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.
