Science & Technology

21
Aug

Laboratory Instrument Calibration – Are You Covered?

It is paramount that a Quality Control laboratory has a calibration and preventative maintenance program for the laboratory instrumentation so that there is assurance that the instrumentation continues to be “fit for purpose” and that there is confidence in the accuracy and reliability of all analytical instruments.  There should be a controlled, comprehensive list of […]

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11
Jul

Ready or Not Here They Come – Lab Regulatory Inspections

Like death and taxes, eventually every pharmaceutical testing laboratory will get a regulatory agency inspection.  The anticipation of a regulatory inspection will instill great angst even within the most compliant laboratories.  The anticipated inspection might be a periodic inspection, but most often is a Pre-Approval Inspection (PAI).  The anxiety about an impending inspection often triggers […]

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10
Jun

More Time Needed for Comments on Continuous Manufacturing Draft Guidance  

The pre-publication page of the Federal Register Notice posted today (here) a reopening of the comment period for the draft guidance Quality Considerations for Continuous Manufacturing which was originally released February 27, 2019.  That guidance can be found here  . While some (but not too many) firms have embraced the concept of continuous manufacturing, others […]

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28
May

USP Chapter Spectroscopy Identification Tests – Controlling Your Identities!

This post was co-authored by Thu Truong, J.D., Senior Associate, Science and Technology Group, and Ron George, Ph.D, Director, Science and Technology Group Prior to USP 42 – NF 37 (effective April 30, 2019), USP Chapter <197>, Spectroscopy Identification Tests, stated, “The IR absorption spectrum of a substance, compared with that obtained concomitantly for the […]

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24
May

The Treasure Map to Biosimilarity Just Got More Granular

The FDA’s recently published draft guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and other Quality-Related Considerations (here) is a significant improvement over the withdrawn 2012 guidance (i.e., Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product) that it replaced.  The increased level of detail and wider breadth of topics gives a […]

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14
May

Generics and the News – Bad Start to the Week or Just Business as Usual?

From the news stories on the price fixing suits, to the reported revelations about quality in the generic drug industry, or to the publication of a book titled “Bottle of Lies”, it has not been a good start to the news cycle for the generic drug industry this week.  The report on price fixing was […]

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10
May

Biosimilar Interchangeability Guidance Hits the Street

The issue of the use of biosimilars and their uptake in the market has been a discussion point since the first biosimilar was approved in 2015.  Today, the FDA issued a long-awaited guidance on how a firm can demonstrate interchangeability of a biosimilar to its reference licensed product. The guidance is titled Considerations in Demonstrating […]

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