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Quality by design with a focus on biosimilars

Pharmaceutical Technology

Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines.

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What’s next for Container Closure Integrity Testing?

Pharmaceutical Technology

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT. Free Webinar.

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How to choose the right antimicrobial agent for a new pharmaceutical formulation

Pharmaceutical Technology

It is important that preservatives do not compromise the quality or performance of a formulation or product but simply protect it against microbial proliferation throughout the entirety of the product’s manufacture, shelf life, and usage. Other important points to consider include safety and quality. Free Whitepaper.

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Chemical synthesis: containment challenges for HPAPI handling

Pharmaceutical Technology

This process is used to manufacture pharmaceutical products with low molecular weights in large batches within a short timescale. While this is exciting news for the pharmaceutical industry, chemical synthesis presents a number of challenges when it comes to running a manufacturing plant.