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UK MHRA’s Compliance Management Upgrade Includes “Risk Intelligence IT System” for Drug Inspection Targeting

U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) is creating a comprehensive “Risk Intelligence IT System” for determining where to deploy its inspection resources that captures and analyzes a wide variety of inputs from industry, public, and agency information sources....

EC Revises EU GMP Chapter 6 on Quality Systems

In late March, the European Commission published a revision of Chapter 6 of the EU GMPs, which covers quality control. The revision includes a new section on analytical methods transfer that calls for verifying application conformance and having a transfer protocol. Other revisions involve: ● investigating OOS trends ● establishing a risk-based sampling plan ● […]

ISPE Announces Quality Metrics Pilot Program

ISPE announced in mid-March that it will conduct the industry’s first “Quality Metrics Pilot Program” designed to define standard metrics reporting to FDA. The pilot will test a series of indicators that support an FDA risk-based inspection program. ISPE plans to launch the pilot with workshops for industry education and input, involving FDA participation, during […]

Comment Process on FDA’s Proposed Rule on Product Detention During Inspections Reflects Industry Support

The comment process on FDA’s proposed rule on “Administrative Detention of Drugs Intended for Human Animal Use” as authorized under Title VII of the FDA Safety and Innovation Act (FDASIA) has indicated industry’s comfort level with extending the detention authority the agency already had for foods and devices to drug products....

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....

NSF-IPEC 363 GMP Standard Will Provide Risk-Based Approach for Auditing and Certifying Excipient Manufacturers

NSF International is working with the International Pharmaceutical Excipients Council (IPEC) and FDA to turn the IPEC excipient GMPs into a risk-based, certifiable standard with global applicability by the end of 2013, as recognition of the importance of excipient control continues to grow....

Revision of EU Annex 16 Clarifies QP Responsibilities in the Face of an Increasingly Complex Supply Chain

A clear distinction between the release of a batch and its certification by the Qualified Person (QP), directions for what responsibilities the QP can share and how, and a template for use by a QP to sign off on a subset of manufacturing steps are among the significant changes EMA has incorporated into a revision of its Annex 16, which was released for public comment in early July....

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....

FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System

FDA is proposing that the application of the right quality metrics could help create a more flexible and rationalized review and inspection system and is asking for industry input on what metrics would provide the most effective leverage....
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