Tag Archive | "ISPE"

LinkedIn LookIn: Eavesdropping on QbD Conversations

Every so often we like to eavesdrop on some of the better QbD- and Quality-related conversations happening on LinkedIn pharma groups. Here are November’s hot discussion threads. (The group name is in parentheses. Not a member? Ask the group manager for an invite!)

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ISPE Releases Parts 1 and 2 of PQLI Guide Series

ISPE’s PQLI initiative is one of the driving forces behind the industry’s gradual acceptance of QbD and understanding of how it can work in practice. Thus, the introduction of the first two parts of ISPE’s Good Practice Guide represents an important milestone. Part 2 is noteworthy in that it presents a new small-molecule case study. Following is the announcement:

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A LinkedIn LookIn: Pharma’s Hot Summer Discussions

Need an answer to a burning question? Go to one of the thousands of specialized groups on LinkedIn. Here’s a rundown of some of this summer’s more intriguing discussions related to QbD, drug development, and general pharma operational excellence, courtesy of some of our favorite groups. (Note that many of these groups are “members only”–if you’d like to join, simply place a request to the group’s manager.)

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Hot Off the Press: ISPE’s Guide for Science- and Risk-Based Facilities, Systems, and Equipment

ISPE has published a new guide: “Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment.” According to the publication notes:

“Specific implementation guidance is given on meeting the expectations of global regulators and is compatible with ICH documents (Q8 (R2), Q9, and Q10) and ASTM E2500-07. The Guide will be of interest to those following the latest industry and regulatory initiatives, including:

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QbD Classics: Using an Integrated API-Drug Product Approach to Development

What are the must-read texts of Quality by Design? We’ve posed this question on LinkedIn, and have received many nominations and will continue to post them as they come in. (Here is a previous example.) Justin Neway, PhD, VP and Chief Science Officer for Aegis Analytical, has nominated “Quality by Design Using an Integrated Active Pharmaceutical Ingredient-Drug Product Approach to Development”, published last summer in ISPE’s Pharmaceutical Engineering. (ISPE Membership or purchase is required to view the full document.) The article is authored by a Pfizer Groton team of Vince McCurdy, Mary T. am Ende, Frank Busch, Jason Mustakis, Peter Rose, and Mark R. Berry.

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Process Variability? FDA, Heal Thyself

By Agnes Shanley and Michele Vaccarello Wagner

At a recent PharmaManufacturing.com webcast, participants noted, off-line and off the record, that today, delays in Quality by Design (QbD) application review were coming, not from “old timers” within FDA, or traditionalists wedded to old-fashioned quality control methods, but from newly recruited reviewers.

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