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The News in Depth

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and suggestions that emerged at the meeting the agency held in late August to solicit feedback on its quality metrics draft guidance ● biomanufacturing site transfers and the role stress studies are playing at Roche/Genentech in assuring comparability, and ● the challenges in the analytical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.

Clarifying Questions Upfront is Key in Process Validation, US and EU PV Principles in Alignment, CDER’s McNally Stresses 

FDA is advising industry to ensure that their process validation teams clearly articulate and document the questions they are seeking to answer up front, prior to collecting data or executing process qualification (PQ).

Stress Studies Are Playing Key Role For Roche/Genentech in Assessing Biomanufacturing Process Site Transfers

Stress studies are playing a key role for Roche/Genentech in the comparability assessments needed to support its transfer of biomanufacturing processes between sites, reflecting the time savings, sensitivity to differences, and high level of stability assurance that they provide.

Analytical Methods Handoff Pivotal to Successful Manufacturing Site Transfer, and Multiple Pitfalls Lurk, BCG Consultant Stresses at Latin America CMC Strategy Forum

The analytical methods handoff is pivotal to the overall success of a manufacturing process transfer from one location to another, and multiple pitfalls lurk, Biologics Consulting Group’s Christina Vessely cautioned at the 2015 Latin America CMC Strategy Forum organized by CASSS in Brasilia, Brazil in late August.

FDA’s “New Inspection Protocol Project” will Impact How Inspections Are Planned, Conducted, Reported On, and Assessed and Offers a Potential Global Model

FDA’s Center for Drug Evaluation and Research (CDER), in conjunction with the agency’s field organization, has developed and is piloting a new inspection protocol that will impact the scope of what investigators are looking for and how they are assessing and reporting what they find.

IPQ Monthly Update, July/August 2015 in Review

Dominating IPQ’s coverage during July and August were the ongoing developments in FDA’s metrics effort and the industry initiatives it is driving. In focus in this issue are: ● FDA’s new draft guidance and where the agency is looking for input from industry, in particular, in refining it, and ● ISPE’s substantial pilot effort to benchmark on current metrics practices and help make the FDA program more viable and meaningful. A third story explores the increasing significance of pharma’s relationship with excipient suppliers from the vantage point of a senior BMS manufacturing executive, and the related IPEC-Americas/IQ Consortium push for a novel excipient regulatory pathway.

Phased Implementation, Reporting Burden Among Industry Focal Points in Initial Feedback on FDA’s Quality Metrics Draft Guidance

Phased implementation, reporting burden, and the nuances of site versus product reporting were among the focal points of the comments by the various associations appearing at the public meeting held by FDA on August 24 to capture industry’s initial feedback on the agency’s quality metrics draft guidance.

Relationship with Excipient Providers Drawing Increasing Pharma Attention, BMS Exec Stresses; IPEC Urges Regulatory Pathway for New Excipients in GDUFA/PDUFA Comments

An important component in the ability of pharmaceutical innovators to bring their new products to market in the eclipsed timelines in which they need to function will be their relationship with excipient providers, a top manufacturing executive from Bristol-Myers Squibb (BMS) stressed to participants at the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas)/ExcipientFest conference […]
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