Compliance Containment Contamination Marketing 
pharmaphorum
JUNE 8, 2022
Conference Chairman: James Drinkwater, Head of Aseptic Processing Special Interest Group PHSS and Head of GMP Compliance, F Ziel GMBH. Join us to discuss and address the Guidance and Regulation including the EU GMP Annex 1, environmental control delving into the contamination control strategy, Pharma moving forward 4.0
Roots Analysis
APRIL 15, 2024
Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.
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FDA Law Blog
OCTOBER 31, 2021
Furthermore, under the new law, the use of the chasing arrow symbol itself will be a misleading environmental marketing claim in advertising or on a product label unless the product meets the standard of “recyclable.”. g)(4) of the California Public Resources Code; or. g)(4) of the California Public Resources Code; or.
FDA Law Blog
JANUARY 1, 2024
The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. market complaints in 2021 through 2023 but could not provide documentation to demonstrate how the complaints were reviewed or evaluated. Dextrum Laboratories Inc.
FDA Law Blog
NOVEMBER 22, 2022
coli contamination. Food and Drug Administration (FDA), requested withdrawal and destruction of all romaine lettuce on the market because the agency was unable at the time to tie the outbreak to a specific grower or region. Two days before Thanksgiving the following year, the CDC warned U.S. Concurrently, the U.S. 7, 2022 at 1 p.m.
XTalks
MAY 13, 2022
A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.
Roots Analysis
SEPTEMBER 20, 2023
However, there are several hurdles associated with the transition of cell-based therapy products from laboratory to clinical scale, such as regulatory compliance, lack of advanced facilities and infrastructure. Such procedures require sterile and higher-grade clean rooms, along with regular checks on containment levels.
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