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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. QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

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

Pharmaceutical Technology

Antimicrobial agents can be used both as active pharmaceutical ingredient (API) and as excipients. As an API, they are commonly seen in antiseptic creams for skin conditions like eczema and psoriasis or in antiseptic solutions, and in oral products for treating throat infections, gum pain, and cold sores. Free Whitepaper.

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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.

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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.