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INDUSTRY RESOURCES

20
Apr
An Introduction To Pharmaceutical Facility Commissioning & Qualification

The commissioning of a facility, equipment, or system for operation under GMP regulations involves qualification that all operations are suitable for the intended purpose. The facility owner must have traceable verification of the systems, minimizing punchlist items to improve start-up and eliminate problems up front.

Posted in:Manufacturing,
Tags:commissioning,facility,GMP,qualification,
19
Apr
Speed, Cost, Or Quality In Clinical Trials — Don’t Pick Two

Many of you have no doubt heard someone in your current or past organization say, “Quality, cost, and speed — pick two.” This statement refers to the perception that a project cannot achieve all three areas as priorities and therefore the organization must choose which two out of the three to prioritize.

Posted in:Clinical,
19
Apr
The Digital Health Tsunami Is Here. How Is FDA Gearing Up?

The FDA’s Software Precertification Pilot Program moves away from the agency’s long-held stance that it does not “approve companies,” exploring new thinking on how to regulate by reputation and continuous improvement loops, rather than reviewing each and every low-risk product. Might there be a way to replicate this type of thinking for complex products?

Posted in:FDA,
18
Apr
FY2017 FDA Drug Inspection Observations And Trends

This article presents the most recent publication of GMP drug product inspection data from the FDA’s Center for Drug Evaluation and Research (CDER), which addresses drug inspections conducted in FY2017. It looks at five years of data from the FDA, examines data from 2017, and evaluates five years’ worth of trends in GMP inspection enforcement.

Posted in:FDA,Manufacturing,Training,
18
Apr
Choosing The Right Partner For High Potency API Manufacturing

For companies that decide to outsource high-potency active pharmaceutical ingredients (HPAPI) manufacturing, it is critically important to understand what goes into the process of manufacturing highly potent compounds. This article outlines some of the key considerations for HPAPI manufacturing and CDMO selection.

Posted in:Manufacturing,
Tags:high potency api manufacturing,high-potency,hpapi,
16
Apr
How AI Tools Will Transform Quality Management In The Life Sciences

FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.

Posted in:Clinical,Device,FDA,Manufacturing,R&D,
Tags:ai,artificial intelligence,

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