monthly update - International Pharmaceutical Quality

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IPQ

INTERNATIONAL PHARMACEUTICAL QUALITY Inside the Global Regulatory Dialogue VOL. 4, NO. 8

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MONTHLY UPDATE - OCTOBER 2013 INTERNATIONAL

UNITED STATES CMC/REVIEW

CMC/REVIEW

• CBER Focus Intensifying on Export Certification, Adverse Event Databases, and Lab Help in Product Development...2

• ICH Q3D Step 2

GMP/INSPECTION • Comment Process on FDA’s Proposed Rule on Product Detention During Inspections Reflects Industry Support....7 • FDA Draft Guidance on Contract Manufacturing Quality Agreements Joint Drafting of Agreements Needed to Reflect Shared Quality Ownership................................................................12 Successful Tech Transfer to a CMO Depends on Strong Quality Agreement and Open Communication Pathways, FDA Asserts............................................................................20

Vetting of Pre-Step 2 Draft Impacts final Version; LVP and E&L Issues Could Warrant Further Public Comment..............................................................................30 IPEC and a Broader Coalition of Industry Associations Identify Implementation Challenges and What is Needed to Meet Them........................................................40

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Level of Industry Response Reflects Contracting Challenges; Terminology at Issue........................................25

EDITOR’s NOTE: Welcome to IPQ’s “Monthly Update” on key CMC/GMP developments in the US, Europe, and internationally. The IPQ family of publications includes “The News in Depth” and”Updates in Brief” on our website as they occur, “Weekly News Alerts” sent via e-mail, and the “Monthly Update.” IPQ’s suite of offerings support our mission of helping readers understand, engage in and respond to the dialogue and developments around evolving and harmonizing the regulation of drug and biologic quality and manufacturing. Subscribers and license holders to IPQ have access to all of these sources of cutting-edge news and in-depth analysis as well as to the full IPQ archives. Visit IPQpubs.com for further information. Bill Paulson, Editor-in-Chief

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MONTHLY UPDATE - OCTOBER 2013

UNITED STATES CBER Focus Intensifying on Export Certification, Adverse Event Databases, and Lab Help in Product Development Initiatives that will be on the front burner at the Center for Biologics Evaluation and Research (CBER) over the next year include: ● the completion of an electronic export certification system ● the increased use of databases to identify and confirm adverse events with vaccines and blood products, and ● using its extensive laboratory facilities and expertise to help in the development of novel products. CBER Office of Compliance (OC) Director Mary Malarkey emphasized the significance of CBER’s soon-to-be-launched Biologics Export Certification Application and Tracking System (BECATS) in providing an update on her office’s initiatives at the annual PDA/FDA conference in Washington, D.C. in mid-September.

BECATS aims to streamline the process for applying for and obtaining export certificates for CBER-regulated products using an all-electronic Internet-based form of submission. Malarkey noted that the first phase will address certificates for foreign governments, which accounts for about half of CBER’s certificate workload.  She anticipates a roll-out

Editor-in-Chief Bill Paulson [email protected] 202-841-5027

Reporters Ted Seabright [email protected] 571-213-6318

Senior Editor Jerry Chapman [email protected] 317-361-7314

Aaron Kozloff [email protected] 240-678-4637

Chief Financial Officer Rob Morrow [email protected] 301-913-0115 ext.105 Sales/Marketing Coordinator Wayne Rhodes [email protected] 202-841-9470

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