Logo Image
|Articles|February 15, 2002

BioPharm International

  • BioPharm International-02-01-2002
  • Volume 15
  • Issue 2

Using a Model and Tools to Standardize the Preparation for a Preapproval Inspection

Author(s)Barbara Unger

By Barara W. Unger, Don Hill Associates, Inc., pp. 14-18, 71. An effective, well-developed, and versatile preapproval inspection model focuses management and inspectors on conclusions, minimizes process reinvention, and tracks inspection readiness, especially when you are using a contract manufacturer.
To view a PDF of this article from the BioPharm International archives, click this link

Articles in this issue

over 24 years ago

Sale of Your Product Can Prevent Patenting: How to Avoid the On-Sale Bar

over 24 years ago

Outsourcing Outlook: Reaping the Benefits of E-Procurement

over 24 years ago

The Immunogenicity of Therapeutic Proteins

over 24 years ago

Analytical Advances: Calibration Management of Outsourced Calibrations

over 24 years ago

High-Throughput Biopharmaceutical Drug Development: Meeting the Coming Challenge

over 24 years ago

Inside Washington: Costs and Controls Challenge Manufacturers

over 24 years ago

21 CFR Part 11: (Un)Expected Added Value

Related to this article

View more
The BioPharm Brief: Ivonescimab Priority Review in China, Stargardt Gene Therapy Moves Toward Phase 3, and Longer Dosing Intervals for an IBD Bispecific
The BioPharm Brief: Ivonescimab Priority Review in China, Stargardt Gene Therapy Moves Toward Phase 3, and Longer Dosing Intervals for an IBD Bispecific
China’s NMPA grants priority review to Akeso’s PD-1/VEGF bispecific ivonescimab with chemotherapy for first-line biliary tract cancer, VeonGen Therapeutics aligns with FDA on a phase 3 design for its dual-AAV Stargardt gene therapy VG801, and Caldera Therapeutics’ IL-23p19×TL1A bispecific CLD-423 shows a half-life of more than 40 days in a phase 1a trial.
Read more
The BioPharm Brief: A $7 Billion Oncology Option Deal, a TL1A Pivot, and Oral Adalimumab Heads to the Clinic
The BioPharm Brief: A $7 Billion Oncology Option Deal, a TL1A Pivot, and Oral Adalimumab Heads to the Clinic
Boehringer Ingelheim licenses six preclinical ADC and T-cell engager programs from Sino Biopharmaceutical in a deal worth up to $7 billion, Spyre Therapeutics drops anti-TL1A antibody SPY072 in rheumatic diseases after phase 2 misses and turns to hidradenitis suppurativa, and Biora Therapeutics gets ethics approval for a first-in-human trial of its BioJet oral adalimumab capsule.
Read more