IPQ

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IPQ

 •  September 9

Provided below are: ● the table of contents (p.1) ● information about IPQ (p.2), and ● the editor’s note on the issue (p.3) The issue opens with a review of the key priorities of the European Pharmacopeia and its ongoing initiatives to address them. Included are the pharmacopeia’s efforts in ICH Q3D implementation and in the biotherapeutics...

IPQ

 •  August 24

The July 2017 publishing by the European Pharmacopoeia (Ph. Eur.) of revisions to its general chapter, method, and monograph sections is the latest development in the effort by the pharmacopeia to align its coverage of elemental impurities (EI) with the implementation of the International Conference on Harmonization (ICH) Q3D guideline. The ICH Q3D...

IPQ

 •  August 7

Biopharmaceutical manufacturers are seeking to expedite the process of taking multi-attribute methodology (MAM) from the development to the quality control (QC) arena and are working with analytics providers and government agencies to help address the challenges involved. Having shown the effectiveness of the mass spectrometry-based MAM in...

IPQ

 •  July 1

Global excipient and pharmaceutical manufacturers are weighing the complexities and consequences of the new “bundling review” requirement put in place by the China Food and Drug Administration (CFDA) in August 2016, which calls for excipient dossiers to be received, reviewed and approved as part of new drug applications. Prior to the new...

IPQ

 •  June 19

The process of reauthorizing user fees for new and generic drug products has afforded the Center for Drug Evaluation and Research (CDER) the opportunity to work cooperatively with industry to drive significant cultural and process enhancements in its regulation of drug/biologic/device combination products. Commitments related to improving the...

IPQ

 •  May 17

The detection and segregation of non-conforming materials and the justification of sampling plans and locations will be key regulator concerns in reviewing the control system for continuous manufacturing (CM) operations, Vertex is advising based on its experience as the first company to have gone through the CM clearance process at FDA. Vertex...

IPQ

 •  May 4

Provided below are: ● the table of contents (p.1) ● information about IPQ (p.2), and ● the editor’s note on the issue (p.3) The issue begins with a story on FDA’s broad-based effort to strengthen the governance, process and outreach aspects of its handling of combination products. Also in focus is the intensive dialogue that is happening...

IPQ

 •  April 17

The deployment of continuous manufacturing (CM) is prompting the pharmaceutical industry to understand better the characteristics of the excipients they are using and work more closely with suppliers to assure that the materials are fit for purpose. CM is also prompting a harder look at how to open up the clearance pathway for new/modified...

IPQ

 •  April 12

FDA’s Office of Pharmaceutical Quality (OPQ) has gained enough experience in interacting with industry on implementing continuous manufacturing (CM) operations to be able to offer more concrete advice on the considerations that warrant extra attention. One of OPQ’s primary objectives is to encourage the development and adoption of emerging...

IPQ

 •  March 21

FDA’s broad-based effort to “modernize” its regulatory process for products that contain some combination of drugs, biologics and devices gained significant momentum during 2016, and the impact of the effort will continue to increase as 2017 progresses. Better assessing and addressing the challenges involved in coordinating the diverse regulatory...