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05.11.21 FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities
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In this free live webinar, we will provide an overview of the strategy to speed up the migration from a vial to a pre-fillable syringe when developing a vaccine. We will discuss the different packaging characteristics, assess the syringe platform, and present what Stevanato Group can offer to support pharma partners in delivering a safe and effective vaccine.
Featured Editorial
On April 14, 2021, the FDA released a new guidance,
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance and shares how to submit public comments for FDA consideration.
04.15.21 An Introduction To Trending In Environmental Monitoring Programs
In this
Consumer Reports-style analysis, ISR presents data on 383 service encounters from 123 respondents who have been involved in outsourced drug product projects in the past 18 months. This report will help biopharmaceutical companies make more informed CMO decisions and CMOs optimize operational and marketing strategies. You can access a free preview here.
Featured Editorial
By Crystal M. Booth, PSC Biotech
Trending environmental monitoring (EM) data are a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, I look first at the regulations and guidelines around EM.
04.01.21 Auditing Electronic Batch Records For cGMP Status
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Pharmaceutical Online and Techceuticals, in collaboration with Federal Equipment Company, are excited to announce Virtual Pharma Expo: Oral Solid Dose Manufacturing. Don’t miss this FREE LIVE event on May 5th & 6th featuring 15-minute presentations with leading OSD packaging and process equipment manufacturers. Register Now.
Featured Editorial
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
This article presents some advice for auditing electronic batch records to assess their cGMP status. This is useful in the qualification stage and essential once the electronic record system is in operation.
Industry Insights Article