To create the specificity required for pharma packaging quality and safety, the USP deemed it necessary to create two sections of 661: USP 661.1 deals with plastic materials of construction USP 661.2 focuses on the suitability/safety of the complete packaging system In the time leading up to Dece...
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Get Prepared for New Plastic Packaging and Manufacturing Materials Requirements Our experts break down how organizations can start planning today for new USP guidelines coming down the pike. By Jonathon Salsbury, director, GMP Lab Cheyann Wetteland, Ph.D., research scientist, GMP Lab In clinical ...
information could also be used for drug procurement purposes. Where the comparator pharmaceutical product is not clearly defined, criteria are suggested that are provided in a decision- tree format (see Figure 1). This permits the selection of a comparator pharmaceutical product. The guidelines on...
Explore a wide range of quality control standards from USP, EP, BAM, NIST, and more for pharma labs. Certified Reference MaterialsCertified Reference Materials: CRMs for forensic, clinical, environmental, pharmaceutical, and food & beverage testing. Analytical Reference StandardsExplore our broad ...
As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation...
Quality by Design: The Case for Change First-Hand Look at India's Pharma Services Sector Industrialized Production of Human iPSC-Derived Cardiomyocytes for Use in Drug Discovery and Toxicity Testing Change and Innovation USP Product-Class Standards for Biologics How Multipurpose is a Disposable Bioreac...
Cells in the logarithmic growth phase were selected for the experiment. The USP28 inhibitor AZ1 was purchased from Good Laboratory Practice bioscience.AZ1 was stored in dimethyl sulfoxide (DMSO) solution. Cisplatin injection purchased from Hansoh Pharma (China). Cell viability and colony formation ...
Commonly, the guidelines used to generate these tests and procedures are defined by global pharmacopeias including the USP and EP, all of which require that the performance of UV-Vis spectrophotometers is regularly verified. The updated USP chapter <857> guides instrument validation protocols for ...
(HS)-GC-MS, GC-MS, LC-MS or ICP-MS) where the Analytical Evaluation Threshold analysis (AET) and study design would follow recommended industry guidelines such as the USP <665>/USP <1665> or BioPhorum Best Practices Guide for Extractables Testing of Polymeric Single-...