Whitepapers

This chapter, excerpted from the book Good Distribution Practice, provides background on serialization and how, despite initial investment of time and money, it will allow greater tracking of medicinal product through the drug supply chain and reduce the chance that falsified medicines end up in the hands of the public.

At Rite-Hite, we have many solutions for the pharmaceutical industry along with the knowledge and experience to help you address the issues you face with your clean areas. We keep up-to-date on best practices, new design and technology and the latest trends in the industry.

This whitepaper explains how the use of pharmacopeial reference standards for quality control can help reduce risk, minimize work, and accelerate drug product development.

An overview of data processing in the HR MAM workflow and demonstration of software for flexibility in different phases of drug development and manufacturing

The following document the emerging threat to the global gelatin supply chain and the dependency of the US healthcare system on foreign supply for key pharmaceutical ingredients.

The ebooklet addresses findings from the Consortium on Adventitious Agent Contamination in Biomanufacturing’s survey of virus contamination experience and mitigating controls and other research, reviews recommended risk management tools to avoid adventitious agent contamination, and provides a framework for a risk management process

This chapter, excerpted from the book Good Distribution Practice, draws on the author’s experience with shipping pharmaceuticals under controlled conditions, particularly over long distances, and his work toward solutions providers in the field.

Tablet press design innovation has traditionally centered on large-scale production equipment, however, there is increasing focus on the smaller-scale, mid-range models that must have the capability to support product development, scale-up, tech transfer, clinical batch manufacturing, small and medium batch production, and continuous manufacturing applications. This range of capabilities demands unique features and design flexibility.

Bioavailability of insoluble compounds is one of the biggest challenges to drug delivery. Improving bioavailability is crucial to creating dosage forms that are easy to use and meet demands for patient compliance. 

This excerpted chapter of a longer book reviews the history of the Food, Drug, and Cosmetics act, including milestones, subsequent laws, and predictions for future laws and regulations; explores the role of Regulatory Affairs in product development; and addresses the importance of a quality management system and organization in bringing products to market.

The COVID-19 pandemic has forced countless difficult decisions to be made in the face of unprecedented uncertainty. Patients, consumers, and industry professionals alike are looking for guidance, support, and answers. With increased demand on pharmaceutical manufacturers to develop a COVID-19 therapeutic alongside all the existing treatments that are still needed by millions, there follows the growing need for strict quality control processes, and the ability to test and release large volumes of newly manufactured vaccines.

This ebooklet offers practical advice on the need for SOPs, how to write them, and what should be included in them.

Plan production automation around audit readiness and regulatory compliance. Understand data integrity considerations, infrastructure components, and new technologies supporting GxP. 

This whitepaper describes the microencapsulation process of coacervation using both aqueous and solvent pathways, and the many benefits for drug developers.

This whitepaper details how technological advancements by Syntegon and Corning allow for ultra high speed pharmaceutical fill/finish.

An overview of the various components that go into measuring OEE, and ways product inspection equipment can affect OEE in the pharmaceutical industry.

Single-Use Systems offer biopharmaceutical manufacturers unique benefits in new and existing applications. Emerson’s measurement instrumentation solutions offer newfound flexibility to scale operations.

Optimizing the Manufacture of Cell and Gene TherapiesDescription: Cell and gene therapies are an emerging field that is seeing rapid growth. The manufacture of these advanced therapy products is not yet fully optimized, however, and still carries risks and challenges to process quality, scale up and efficiency. This ebook on Optimizing the Manufacture of Cell and Gene Therapies discusses strategies to making these cell or gene therapy products a success.

Importance of compatibility studies for drug-device products How to test for in-use stability, chemical compatibility, and biocompatibility

- Why having a secondary biocide supplier is important - Information you should gather when selecting a secondary supplier.

Online tool predicts the optimal formulation of drugs New way to predict compressibility and compactibility

• Container closure integrity testing is vital for sterile injectable products. • The Headspace Gas Ingress method is a robust detection method of critical leaks. • This method is an upgrade to the blue dye test and can be scientifically validated.