October 2018

09
Oct
WOMAN APPLYING CIRCULAR FLESH COLOURED NICOTINE PATCH TO ARM IN CLOSE Up

New Transdermal Guidances Set the Stage for 23 Revisions in Bio Recommendations

Today FDA announced finalizations in two guidance documents for transdermal systems (TDS) one relative to skin adhesion studies (here)  and one related to skin irritation and sensitization studies (here).  The revisions to the previous drafts came after FDA considered a number of industry comments to those drafts. With the finalization of the guidance documents, FDA […]

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08
Oct
Female chemist adds drops of blue substance into test tubes, lab research

How Current is Your Stability Program?

A quick survey of recent FDA Form 483s shows that firms are struggling to meet FDA expectations for timeliness of stability testing.  During the last twelve months, the FDA has issued at least sixteen Form 483s for observations related to the timeliness of stability sample testing. Neither the current guidance ICH Q1A(R2) “Stability Testing of New […]

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03
Oct

Fran Zipp Elected Vice Chair of ISPE International Board of Directors

LCS would like to congratulate the newly elected International Board of Directors for ISPE for 2018-2019. This Board is responsible for devising strategy and governance of ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The […]

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01
Oct
Close-up of unrecognizable laboratory worker viewing statistical data while analyzing result of DNA test

The Importance of Trending During Laboratory Investigations

It is understandable that during an investigation the initial focus is determining the cause along with the associated impact assessment and the identification and implementation of a corrective action.  However, what can get overlooked during the investigation process is the importance of trending.  This is a key component of root cause confirmation, assessing the appropriateness […]

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