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INDUSTRY RESOURCES

13
Jul
How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often

The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. The agency also introduced a multiyear resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections.

Posted in:FDA,Manufacturing,
Tags:data,FDASIA,GMP,inspection,surveillance,
11
Jul
Regulators And Standards Groups Take Steps To Address Emerging Technologies In Biopharma

Manufacturers, suppliers, and regulators have recognized that introducing new technologies also introduces a degree of unfamiliarity and uncertainty.

Posted in:Manufacturing,
Tags:BioCM,biopharma,biopharmaceuticals,cell and gene,CM,single-use,SUS,
Integrating Risk Management In The Quality Management System — A Primer
10
Jul
QbD In Clinical Trials: A Focused Approach To Quality Assurance And Risk Management

The clinical trials enterprise has long assumed that when it comes to ensuring trial quality, data is king and more is better. Not only was it considered essential to gather detailed data on every aspect of a clinical trial, but that data had to be double-entered, checked, queried, cleaned, and validated.

Posted in:Clinical,
Tags:CTTI,QbD,quality,quality by design,risk,
04
Jul
5 Golden Rules For Effective (And Inspection Ready) OOS Investigations

Following these five rules will ensure that OOE investigations are conducted in a scientific and meaningful manner, with each instance providing a genuine opportunity for improvement.

Posted in:Manufacturing,
Tags:CGMP,GMP,investigations,OOE,OOS,
22
Jun
Is Your Facility Aging? How Can You Tell And What Should You Do?

“Aging facilities” is a trendy catchphrase that has taken hold in the biopharmaceutical industry the past few years. While most of us might think we understand intuitively what the words mean, perhaps we don’t. To that end, let’s dispel a myth right away.

Posted in:Manufacturing,
Tags:aging facility,biopharmaceutical,
21
Jun
A Simulation-Based Approach To CRO Selection

Protocol or clinical trial simulations have been on the radar screen of the industry for quite some time as a technique for optimizing trial design and decision making.

Posted in:Clinical,
Tags:CRO,CRO selection,modeling,simulations,

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