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IPQ Monthly Update, October, 2013

The Monthly Update for October includes three stories on FDA's draft guidance on quality agreements with CMOs, more on the FDASIA supply chain implementation efforts, as well as in-depth coverage of ICH’s release of its Step 2 draft of Q3D on elemental impurities. An update on CBER’s compliance initiatives is also provided....

Successful Tech Transfer to a CMO Depends on a Strong Quality Agreement and Open Communication Pathways, FDA Asserts

A detailed description of how a drug product owner will transfer technical knowledge to a contract manufacturer needs to be part of a quality agreement, FDA officials are stressing....

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....

FDASIA Section 707 Draft Guidance on Obstructing Inspections Draws Industry Comments; Investigator Subjectivity Among Issues Raised

FDA’s new draft guidance on “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection” has drawn some industry concern regarding the degree of subjectivity it affords investigators in determining when the lines have been crossed....

IPQ Monthly Update, July/August 2013

The IPQ Monthly Update for July/August 2013 is now available....

FDA Data Integrity Concerns Continue in India as Three More Firms Draw GMP Warning Letters

Three warning letters recently issued on findings at facilities in India indicate FDA’s continued focus on data integrity as a central concern of its international inspection program – and in the Indian arena, in particular....

FMD Implementation in Europe Drives Better API Sourcing Knowledge and Interagency Communications

Implementation of Europe’s Falsified Medicines Directive (FMD) has shed important light on what the active pharmaceutical ingredient (API) part of the global pharmaceutical supply chain actually looks like and has led to enhanced communication between the countries that participate in it....

FDA Piloting Electronic FARs as Focus Intensifies on Defect Data Mining

FDA is piloting an electronic Field Alert Report (FAR) system that could help foster improved defect detection, prevention, and mitigation, and further empower the agency’s ability to understand where the industry shortfalls are and the particular firms that need heightened enforcement attention....

Analyses of Defect Reports by Ireland’s IMB and FDA Highlight Packaging and Labeling as Key Pharma Manufacturing Problem Area

Analyses by the Irish Medicines Board (IMB) and FDA of their data on deviation reporting over the past few years indicate the prominence of packaging and labeling as a problem area in the pharmaceutical manufacturing arena....

Pharmacy Compounding Legislation Introduced in Both Houses of Congress Provides for FDA Regulatory Flexibility and Inspection Authority

Legislation has been introduced in both houses of Congress that would provide FDA with the power and flexibility it needs to define the regulatory requirements for high-risk compounding operations and the authority to inspect those that engage in interstate commerce....
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