IPQ’s Monthly Update for January 2011 Now Available
In focus in IPQ’s international coverage for January are the latest developments in the effort by the ICH Q11 Expert Working Group to craft a viable drug substance guideline, which is nearing the Step 2 publication finish line....
February 24, 2011 | Posted in The News in Depth | Read More »
Extensive Vetting of FDA’s Draft Process Validation Guidance Smoothes Its Transition to Final Form
The extensive vetting process on FDA’s draft process validation guidance confirmed to the agency that only a relatively few clarifications were needed to bring the draft into final form....
February 23, 2011 | Posted in GMP Policy, Production/Validation, The News in Depth, US/Canada | Read More »
Uncertainties in Subvisible Particulates Need to Be Understood, FDA Tells Biotech CMC Strategy Forum
The uncertainties around subvisible particles (SVPs) may warrant their being controlled as a critical quality attribute, FDA Office of Biotechnology Products Division of Therapeutic Proteins (DTP) Deputy Director Barry Cherney stressed at a CASSS/FDA CMC Strategy Forum in Washington, D.C in January....
February 20, 2011 | Posted in Biotech, Biotech Therapeutics, CMC Standards, The News in Depth, US/Canada | Read More »
California’s Findings of Gaps in Heparin Recalls Highlighted at FDA Track and Trace Workshop
Evidence of the gaps in the 2008 heparin recall process uncovered by the State of California underscores the need for a track and trace system for prescription drug products, CA State Board of Pharmacy Executive Officer Virginia Herold maintained at an FDA-sponsored public workshop on February 15-16 at its White Oak, MD campus....
February 17, 2011 | Posted in GMP Enforcement Activity, Recalls, Supply Chain/GDPs, The News in Depth, Track and Trace, US/Canada | Read More »
Korea is Pressing Forward on CMC/GMP Harmonization Quest
Korea’s quest to more closely harmonize its CMC and GMP quality regulatory processes with ICH/global norms is creating openings for outside companies and regulators to work with the Korean FDA (KFDA) to resolve remaining differences.
February 14, 2011 | Posted in Asia, International Harmonization, Other Organizations, The News in Depth | Read More »
FDA and EMA Will Launch Collaborative QbD Application Review Pilot
FDA and EMA will be conducting a pilot program for joint review of the quality-by-design component of new drug marketing applications – bringing the once-distant vision of a common review process a significant step closer to reality....
February 10, 2011 | Posted in ICH Q8-10/QbD, International, International Harmonization, The News in Depth | Read More »
Baxter Puerto Rico Warning Letter, Recalls Follow FDA Findings of Problems with Complaint Investigations
FDA findings during a mid-2010 inspection at Baxter’s facility in Jayuya, Puerto Rico that appropriate action had not been taken to resolve problems reported in complaints and confirmed in the firm’s own internal investigations resulted in a multi-product recall the following month, a follow-up inspection of a companion facility in Puerto Rico two weeks after the recall, and an FDA warning letter covering both facilities three months later in late January....
February 6, 2011 | Posted in GMP Deviations/Warning Letters, GMP Enforcement Activity, Injectable, Recalls, The News in Depth, US/Canada | Read More »
Heparin API Manufacturer SPL Draws Warning for Complaint Handling and Supplier Auditing
Inadequate follow up to customer complaints – a key theme in recent FDA drug GMP warning letters – was again on the front burner in a warning letter issued in late January to Scientific Protein Laboratories (SPL) in the wake of the agency’s continuing investigation into the 2008 heparin contamination crisis....
February 6, 2011 | Posted in API, GMP Deviations/Warning Letters, GMP Enforcement Activity, The News in Depth, US/Canada | Read More »
Value of Attribute Risk Ranking in Process Development Recognized by ICH Q11 EWG
The current working draft of ICH Q11 promotes the use of risk ranking of quality attributes as a valuable tool in applying quality-by-design (QbD) principles to biotech drug substance development and manufacturing....
February 2, 2011 | Posted in API, Biotech Therapeutics, ICH Q11, International, International Harmonization, The News in Depth | Read More »
