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The News in Depth

Industry is Urging Latin American Agencies to Cooperate in Filling Lifecycle Management Regulatory Gaps for Biologics

The Latin America Federation of the Pharmaceutical Industry (FIFARMA) is advocating the need for the agencies in the region to extend the progress they have been making in regulating the approval process for biologics and cooperate on filling the regulatory gaps for their life-cycle management.

More Structured, Interactive Process To Drive Convergence in Latin America Advocated by Biotech Product Regulators and Industry at CMC Strategy Forum in Brasilia

The need for a more structured, interactive process to drive convergence and resource sharing among the regulatory agencies of Central and South America – potentially drawing on elements of the European model – was a dominant theme among the industry and regulator participants in the second annual CMC Strategy Forum Latin America held again in late August 2015 in Brazil’s capitol city Brasilia....

IPEC Continues to Urge Family Approach in Dialogue with FDA on Improving Inactive Ingredient Database

IPEC-Americas and the Generic Pharmaceutical Association (GPhA) are continuing their advocacy of FDA incorporating a family approach in the toxicology assessment of excipients as they work with the agency on further improving the inactive ingredient database (IID) to support better drug development and more efficient FDA reviews.

Broad-Based ICH Q12 Expert Working Group Supporting Initiative’s Urgency and Viability, EWG Members Affirm at GPhA Conference

The broadening of the ICH Q12 Expert Working Group (EWG) to include parties not traditionally associated with the ICH process may be facilitating, rather than hindering, the effort to meet the tight timelines set up for the guideline’s completion as well as enhancing its global relevance, EWG members are affirming.

Global Change Protocols Proposed as Part of a More Standards-Based Approach to Regulating Life Cycle Management Internationally

Globally standardized change management protocols that would clarify the expectations internationally for implementing various types of manufacturing changes is among the proposals that are now on the table as industry and regulators explore what a more scientifically-based, efficient and harmonized quality regulatory paradigm could look like.

Industry Experts Shed Hard Light on Negative Impacts of Current Complex Post-Approval Change Regulatory Situation Globally, with ICH Q12 in View

The vast resource drain that the current post-approval change regulatory situation globally is creating on both industry and regulators is in sharp relief at public venues where the future of pharmaceutical quality regulation is being discussed.

IPQ Monthly Update – October 2015 in Review

The coming into force of a significant revision of EU GMP Annex 15 in early October, and its insertion into the PIC/S GMPs, has created heightened attention on the evolving global process validation expectations at recent public forums. The October Monthly Update explores: ● the changes made in the revision and their impact ● how the annex now compares with FDA’s process validation guidance, and ● what regulators around the world are now expecting and the problems they are finding during inspections in reviewing industry’s PV performance.

Risk Assessments, Data Integrity, Documentation, and Deviations Will be High on EU Radar Screen in Auditing Process Validation With Revised GMP Annex 15 In Effect

Risk assessments, data integrity, documentation organization and deviation handling are issues that will be high on the radar screen of European inspectors in reviewing how companies are validating their processes, in accord with the increased emphasis the issues have received in the revision of EU GMP Annex 15.

PIC/S Relationship is Impacting Process Validation Expectations in Asia Pacific Region, Although They Vary in Practice, ISPE’s Asia Network is Reporting

The strong influence of PIC/S in the Asia Pacific region is impacting the expectations for process validation, although those expectations vary significantly in practice, the ISPE Asia network is reporting.  

IPQ Monthly Update – September 2015 in Review

In focus in IPQ’s coverage during September: ● FDA’s “New Inspection Protocol Pilot” (NIPP), which has significant implications for pre-approval, surveillance, and for-cause inspections going forward ● the thoughts, concerns and suggestions that emerged at the meeting the agency held in late August to solicit feedback on its quality metrics draft guidance ● biomanufacturing site transfers and the role stress studies are playing at Roche/Genentech in assuring comparability, and ● the challenges in the analytical methods handoff component of the site transfer process.
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