ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

Documentation 52

Documentation Dosage Packaging Communication 52

The Checkup by Singlecare

DECEMBER 26, 2023

A supplement package may claim it contains lion’s mane mushroom, but it may not specify what part of the mushroom it’s made from. Food and Drug Administration (FDA) does not regulate nutritional supplements in the same way that it regulates medications. Dr. Cooperman explains. Fr) Pers.

Immunization 52

Immunization Dosage Packaging FDA 52

ISPE

JANUARY 11, 2023

For example, the equipment for blending and packaging large-volume, high-viscosity formulations is complex, and the residues can be challenging to remove. Bethesda, MD: PDA and River Grove, IL: DHI Publishing, 2009. Bethesda, MD: PDA and River Grove, IL: DHI Publishing, 2009. link] 4 Pluta, P. Process Validation Basics.”

Method Validation 52

Method Validation Documentation Packaging Compounding 52

ISPE

SEPTEMBER 11, 2023

m/s recommendation made its way into the US Food and Drug Administration (FDA)’s “Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice” 7 and into the EC GMP Annex 1 “Manufacture of Sterile Medicinal Products” in 2003. 4 (2009): Online Exclusive: [link] 10 US Food and Drug Administration.

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Documentation FDA Packaging Communication 52

The Thyroid Pharmacist

JULY 29, 2022

This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating. 2009 Oct-Nov;25(9-10):577-81. 2009 Oct;16(5):385-91. 2010;20(7):755-761. Empting LD.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Labelling 52

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

Packaging 52

Packaging Compounding Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 6, 2023

As of 2022, there were 15 drugs (see Table 1) manufactured using CM elements that have received FDA approval, with GSK, Pfizer, and Vertex owning approximately 60% of the market share, followed by Janssen/J&J with about 13%. Table 1: List of FDA-approved commercial products using CM elements.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

APRIL 8, 2025

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. International Council for Harmonisation (ICH), 2009. Boca Raton: CRC Press. International Council for Harmonisation (ICH), 2022.

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Documentation Packaging FDA 52