American Pharmaceutical News In Review

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March 23, 2022

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Continuous monitoring system compliance with Part 11

The FDA and the European Commission published 21 CFR Part 11 and Annex 11 respectively to ensure that computerized and automated systems did not create more risk than manual paper-based systems. This webinar expands on how vendors have risen to the dual challenge of both regulations, while meeting the operational needs of GxP-regulated organizations and risk reduction features. Webinar On Demand

	Industry News

Teva Reaches Agreement With Rhode Island to Settle Opioid-Related Claims
Teva Pharmaceuticals has reached an agreement with the Attorney General of Rhode Island that settles... read more »

FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters
The FDA is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory ... read more »

Health Canada Authorizes Use of the Moderna Spikevax (50 mcg) COVID-19 Vaccine in Children 6 to 11
Health Canada authorized the use of the Moderna Spikevax (50 mcg) COVID-19 vaccine in children 6 to ... read more »

FDA Guidance on Ophthalmic Products: Policy for Compliance with 21 CFR Part 4
The FDA has issued the guidance for industry, Certain Ophthalmic Products: Policy Regarding ... read more »

	Featured Articles

European Pharmacopoeia Approach to Testing for Pyrogenicity The texts of the European Pharmacopoeia (Ph. Eur.) play a major role in ensuring the quality of medicines in Europe. They consist in general chapters ... read more »

Purification Strategies for Recombinant Therapeutic Proteins Many biopharmaceuticals are recombinant proteins obtained by biotechnological processes. In various steps of the pharmaceutical value chain, from drug... read more »

	Featured Video

On-Demand Webinar: Microbial Identification in a Manufacturing Environment
In this webinar we will discuss how recent technological developments allow for rapid micro testing and rapid micro identification, focusing on the ... watch »

On-Demand Webinar: Unified Particle Analysis by Raman and Infrared Microscopy
In this webinar you’ll learn: Identification of unknown particles in a wide variety of manufacturing processes. Reverse engineering and failure ... watch »

	Featured Products

Model 2500 Select Bathless Dissolution System
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	Featured Whitepaper

eBook: Key Learnings in Mycoplasma Detection for Biologics Quality Control
It is important for the safety and purity of biological products to assure that cell substrates and unprocessed bulk material used during manufacture are free of mycoplasmas. Additionally, regulatory ... read more »

Microbiological Quality of Non-sterile Products: Culture Media for Compendial Methods
High quality harmonized USP <61> & <62> compliant media is key to successful non-sterile release and incoming testing of materials that need to be free of specified and objectionable microorganisms. Download ... read more »

	Events

Drug Discovery Chemistry
Hilton Bayfront – 04/18/2022
Focused on discovery and optimization challenges of small molecule drug candidates, Drug Discovery Chemistry is a dynamic in-person and online event ... event details »

IFPAC 2022
North Bethesda, MD – 06/12/2022
IFPAC brings together experienced professionals and the next generation of leaders to share in discussions, give input and get ideas for the future ... event details »

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