Pharmaceutical Technology

FEBRUARY 3, 2023

Compared to other dosage forms, tablets are simpler to manufacture, package, and transport. Tablet manufacturing, which is the most common OSD form, takes an API dry powder ingredient and compresses it to form tablets, which can be coated or uncoated.

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ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. CPP 26 GMP Compression tooling (PQS) CPP 2 IPC Tablet hardness (P.3.4)

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ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. CPP 26 GMP Compression tooling (PQS) CPP 2 IPC Tablet hardness (P.3.4)

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Pharmaceutical Technology

DECEMBER 6, 2022

Nowadays, you have drugs against cancer which have a very high impact even at a very low dosage.”. “The drugs we had 30 to 50 years ago do not even pass the minimum standard of acceptable drugs these days because they are not efficient enough to be seen of value,” says Villa.

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Pharmaceutical Technology

FEBRUARY 21, 2023

For Skyepharma, a CDMO specialising in oral solid dosage forms, notable reductions in costly product waste was one advantage. Beyond the obvious benefit of freeing up the industrial press for commercial manufacturing, this can lead to several cost savings. On an industrial press, this would have been 204kg.

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The FDA Law Blog

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.

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ISPE

JULY 5, 2023

13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter. In addition to the FDA, health authorities in Canada, Europe, Australia, Japan, Switzerland, and New Zealand have also approved applications with CM for the production of solid oral dosage forms.

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Pharmaceutical Technology

MARCH 7, 2023

There are also outside variables that can affect the flow of powders, requiring specific dosage methods to achieve the desired result. The flow and/or the dosage of the product will impact the particle size distribution (PSD) curve of the milled product, as well as the temperature of the product.

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ISPE

JULY 6, 2023

For much of the pharmaceutical industry, batch manufacturing (BM) processes that have been relied upon for decades remain the preferred approach for most oral solid dosage (OSD) drug products. Office of Pharmaceutical Quality (OPQ) White Paper. March 2023. www.fda.gov/media/165775/download 7 US Food and Drug Administration.

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ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” EFPIA White Paper on CMC Development, Manufacture and Supply of Pandemic COVID-19 Therapies and Vaccines.” doi:10.1016/j.jbiotec.2015.06.388

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