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WHO Releases Storage/Transport Supplements

WHO has released for review a set of supplements on its Technical Report Series, No. 961, 2011 Annex 9, which provides a “model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products.” The supplements cover: ● temperature and humidity monitoring systems for transport operations ● temperature and humidity monitoring systems for fixed […]

PDA Releases Revised Technical Report 13 on Environmental Monitoring

A revised version of the PDA Technical Report 13 was released in late May. This technical report serves as a resource on controlled environmental test methods for sterile product manufacturing. The revision updates the previous 2001 version, reflecting the changes to regulatory guidelines, international standards, and scientific advances in environmental monitoring. The report is available […]

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....

Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention

An analysis of FDA drug GMP warning letters issued since the beginning of 2012 highlights the agency’s increasing focus on enforcement outside the US – and on laboratory practices at foreign facilities, in particular....

EDQM Clarifies CEP Evaluation Policy

In late March, EDQM clarified its approach to assessing new applications for CEPs. The policy document explains that the process is handled in two rounds: • the evaluation of the original application, and • if necessary, the evaluation of additional information upon request from EDQM. Following these two rounds, an application lacking the necessary data […]

WHO Revising its Guideline on “Hold Time”

In late February, WHO published a revised draft of its guideline on best practices to follow when designing hold time studies. The new draft adds the recommendation that manufacturers consider using a “most probable” rather than a “worst case approach” to hold times.

IPQ Monthly Update, February 2014

In focus are the nexus of problems facing industry and regulators in the global CMC arena. The stories explore: ● the post-approval change constrictions in Japan and how they compare and interface with those globally ● the discussions among a panel of global regulators on expediting reviews, and the implications for the CMC review process ● the impact that the global regulatory maze is having on vaccine suppliers, and ● the challenges the biotech industry faces in making even minor, low-risk changes post-approval, and what needs to be done to address them....

Industry Proposals for Addressing Post-Approval Change Burdens Include Harmonizing on Commitments and Classifications

Biopharmaceutical firms are calling for a global effort to decrease their heavy post-approval change filing burdens that would clarify and harmonize change classification and submission requirements on a risk-based foundation....

International Panel of Regulators Spotlights Current Biotech CMC Regulatory Problems and Convergence Pathways

The limitations, constraints and disconnects in the current CMC regulatory processes around the world are emerging into high relief as the biopharmaceutical community wrestles with how to get new medicines that fill critical healthcare gaps more rapidly to patients and how to facilitate manufacturing adjustments that better assure the quality of marketed products....

Global Quality Regulatory Maze Jeopardizes Vaccine Supply, IFPMA is Stressing

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) is throwing a spotlight on the impact that the current tangled global regulatory web is having on the ability to supply vaccines to the people who need them....
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