QA/QC Manufacturing

Overview

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The importance of reliable, rigorous quality analysis and quality control in pharmaceutical manufacture and distribution cannot be overstated. Consumers trust your products to safely and effectively deliver medicines that improve and sustain life. To provide this assurance across a wide variety of therapeutic modalities and drug delivery mechanisms, you need a partner that understands how to build a solution that unifies instrument results, data integrity, and regulatory compliance.

Imagine the ability to integrate data from chromatography, molecular spectroscopy, elemental spectroscopy, as well as gas and liquid phase mass spectrometry within a single report, from a single software platform. LabSolutions is a scalable solution for your laboratory data, from both Shimadzu instruments and non-Shimadzu data sources, that offers cGMP and FDA compliance features to ensure the integrity and quality of your results.

If your needs are to supply high-purity water for pharmaceuticals processing and manufacture or water for injectables, Shimadzu can help meet the demands of USP <643> compliance. Limits for elemental impurities established by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and USP, are continually updated to modernize methodologies and address emerging concerns. Shimadzu offers a wide range of solutions for ICP-OES, ICP-MS, and X-ray fluorescence that meet the needs of USP <232> and <233> today and prepare your lab for future regulatory demands.

Whether your tasks involve routine potency and impurities analysis by USP monograph, or testing the push-out strength of blister pack OTC tablets, Shimadzu has the instruments, service and support to help you maintain up time and avoid Out of Specification results before they happen.

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USP Application Compendium

Learn more about USP monograph and other applications for FTIR, GC, Residual Solvents per USP <467>, HPLC including modernization of methods per USP <621>, Physical Testing per USP <915> and <1912>, TOC per USP <643> and <661.1-2>.

From the synthesis of the first drug candidate through to QA and lot release, the quality, integrity, and accessibility of your data is key to the success of delivering new therapeutics safely and effectively to the world. With the strength of Shimadzu as a multi-instrument solution provider, we have built a software ecosystem that allows users to imagine single-point workflows that span every aspect of analytical measurement and analysis. Imagine the ability to integrate data from chromatography, molecular spectroscopy, elemental spectroscopy, as well as gas and liquid phase mass spectrometry within a single report, from a single software platform. LabSolutions is a scalable solution for your laboratory data, from both Shimadzu instruments and non-Shimadzu data sources, that offers cGMP and FDA compliance features to ensure the integrity and quality of your results. We have assisted our partners to create globally integrated instrument control and reporting solutions that meet the regulatory demands and increase user efficiency. Whether your task requires enterprise-level deployment of multiple instruments, or integrating a stand-alone solution into an existing informatics structure, Shimadzu provides solutions that give you confidence in the integrity of your data.

Learn more about our wide range of solutions for ICP-OES, ICP-MS, and X-ray fluorescence to meet needs of USP and prepare for future regulatory demands

As the foundation for in solution medicines and electrolytes, ultra-pure water is of vital importance to public health and best practice in pharmaceutical manufacturing. Monitoring of total organic carbon (TOC) in this water is required according to USP <643> guidelines. To meet your needs, Shimadzu has designed a compact, network-connected solution that is easy to use and compliance-ready.

With an innovative xenon excimer lamp that includes the oxidation flow path, Shimadzu’s TOC-1000e provides superior irradiation of the sample, minimizes carryover, and prevents ozone generation in the instrument. Users will appreciate the touch screen driven operation at the instrument, as well as integration of results into the LabSolutions platform to enable electronic signature workflows and ensure data integrity.

Whether your TOC measurement needs are testing 4 L of water per day, or 4000 L, Shimadzu has a scalable solution that can prepare you to meet current and future regulatory demands.

Particle Size Analysis for Pharmaceuticals

Powders are often used as active pharmaceutical ingredients (APIs) and intermediates of pharmaceuticals. The particle size of APIs and intermediates affects the efficacy of medicines since particle size has an impact on the absorption rate in the gastrointestinal tract after the medicine is taken. It is also important to measure the particle characteristics of raw materials to ensure stable quality production of pharmaceuticals.