Pharmaceutical Technology

OCTOBER 28, 2022

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). This presents an obvious financial benefit in the form of cost savings and helps guarantee the safety and reliability of the final product.

Manufacturing 52

Manufacturing Safety Medicine Pharmaceutical 52

Pharmaceutical Technology

NOVEMBER 30, 2022

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. Many test methods have thus been developed.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical products Manufacturing Pharmaceutical 52

Pharmaceutical Technology

MARCH 2, 2023

On 1 March, the FDA issued the International Council for Harmonisation (ICH) final guidance on the use of continuous manufacturing in drug production. This publication marks the FDA’s proactive steps to ease the pharmaceutical’s industry transition to these advanced processes, states the announcement.

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Manufacturing Pharma FDA Pharmaceutical products 84