The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
|Articles|May 1, 2002
- Pharmaceutical Technology-05-02-2002
- Volume 26
- Issue 5
Analytical Data Management and Archiving: 21 CFR Part 11 Compliance and Beyond
Author(s)Kevin Smith
Pharma laboratories are having to manage and archive more analytical data than ever before. With effective implementation of IT systems, companies can successfully prepare their electronic files for future retieval and use.
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Articles in this issue
over 24 years ago
Harmonizing Standards and Specificationsover 24 years ago
Polymers in Transdermal Drug Delivery Systemsover 24 years ago
Expanding the Use of Child-Resistant Packagingover 24 years ago
Outsourcing Outlookover 24 years ago
E-Procurement — Reverse Auctions and the Supplier's PerspectiveAdvertisement
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Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
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