INSIGHTS ON QUALITY CONTROL
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Why The FDA General Calibration Requirements Are Not Enough
Calibration is a niche industry that is not well understood by many. By choosing an ISO 17025-accredited organization, companies can benefit from external auditing and adherence to accepted standards.
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Nanoparticle Engineering Addresses The Challenge Of Poor Aqueous Solubility
As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.
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Biological Indicators And The European Pharmacopoeia
Here, we review the information concerning biological indicators in European Pharmacopoeia General Chapter 5.1.2, which is more detailed and covers a wider scope than the previous version.
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Key Strategies For MES Software Integrations
To stay competitive in an increasingly dynamic field, pharma and biotech manufacturers are implementing numerous beneficial technologies to automate and streamline production. Explore the power of MES integration.
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Embracing And Implementing Computer Software Assurance Guidance5/18/2023
Pharmaceutical manufacturers are exploring comprehensive computer software assurance (CSA) approaches, the benefits of implementing a risk-based framework, when to apply it, and the first steps to this CSA approach.
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EMPQ And Validation Support Services2/21/2024
A growing pharmaceutical/biotech company hired a global consulting firm for a project that required EMPQ services for qualification activities on a newly completed aseptic processing suite.
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DSC Characterization Of Crystalline Structure In Pharmaceuticals4/11/2023
We dive into DSC testing and analysis of pharmaceutical materials to better understand how to obtain accurate results and avoid potential problems with data interpretation.
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8 Ways Electronic Batch Record Software Boosts Efficiency In Pharmaceutical Manufacturing3/10/2023
Explore the eight key benefits of EBR Software and what makes this digital manufacturing solution superior to the traditional paper-based approach to managing critical documentation.
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Detecting Drug-Excipient Incompatibility In Pharmaceuticals5/5/2023
Here, we focus on how the apparent melting approach can provide a rapid screening protocol for the detection and analysis of drug-excipient incompatibility in mixtures and formulas.
QUALITY CONTROL SOLUTIONS
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Pharmaceutical leak testing is a crucial process for ensuring the safety and sterility of medical and drug packaging, particularly in applications such as CCIT Test Method Validations, pilot production runs, and small-scale production runs. While pharmaceutical manufacturers may not have the resources to invest in leak testing equipment or trained personnel, inadequate testing can have serious consequences. In this article, we will discuss the leak testing services offered by Pfeiffer Vacuum and how they can help manufacturers meet regulatory requirements and ensure the safety of their products.
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What is dissolution testing? Why is it critical? What should you consider for your method validation? Find answers to these questions and more in this quick guide to dissolution testing.
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Sterility testing is a requirement to confirm that pharmaceutical products purporting to be sterile do not contain viable microorganisms before being released and administered to patients. So, it is vital that the method used for testing medical devices, pharmaceutical products, formulations, tissue materials, and other products is both reliable and accurate.
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Do you need a CDMO that will fill the gaps in the drug development process and focus on getting patients the treatments they need faster? Our team of experts at Singota is here to collaborate with you, customizing our services to meet your needs and hit your milestones.
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The most powerful and versatile rheometer for your laboratory.