INTERNATIONAL PHARMACEUTICAL QUALITY provides in-depth coverage of emerging drug, biologic, and combination product CMC and GMP issues and developments, with a mission of helping advance quality regulatory processes globally. Headquartered in Washington, D.C., with an editorial team also based in Europe, IPQ is read by regulators, manufacturers, suppliers, consultants, lawyers, academics, and association staff around the world.
IPQ tracks the industry/regulator dialogue across a wide array of international forums – along with the developments, initiatives, regulations, guidelines, and standards in the quality regulatory arena – to create a uniquely valuable resource for the intelligence gathering, knowledge management, and communication needs of the pharmaceutical community.
Dedicated to helping its readers keep up with and influence the changes to quality regulation as it evolves to match the fast-moving process and product technologies, IPQ provides the depth and breadth of intelligence needed to form strategies, make decisions, and take the right action. The investment in an organization-wide subscription, which allows IPQ’s content to be openly shared internally, is small compared to the benefits and resource-saving potential that IPQ offers.
Subscription fees and other funding, in turn, allow IPQ to provide significant pro bono promotional and coverage-related support to regulatory agencies/networks, public-private partnerships, and non-profit organizations and associations most directly involved in the global CMC/quality dialogue. In support of the mission of the National Institute for Innovation in Manufacturing Biopharmaceuticals to strengthen biopharma education and training programs in the US, IPQ makes its content freely available to all of NIIMBL’s academic members. In cooperation with the association CASSS, IPQ is also extending access to LMIC agencies.
Included on the IPQ.org website as soon as the information becomes available are: ● “Updates in Brief” on recent CMC/ GMP developments of note in the US, Europe, and internationally, with links to the referenced documents and to our related in-depth analysis ● a listing of FDA drug GMP warning letters and EU GMP non-compliance statements with a summary of their content, and ● drug recalls categorized by the general reason that caused
Also listed on IPQ’s homepage is IPQ “Hotspots in the Dialogue” upcoming meeting calendar with links to further information on the meeting.
All of IPQ’s content is provided electronically, and the substantial archive available on the IPQ.org website is easily searchable. Links to documents referenced and cross-links to related previous IPQ coverage are included in the stories and briefs, allowing readers to quickly dig as deeply into an issue and its context as needed. [Click here for information on how individuals from organizations with subscriptions can easily register to access IPQ’s content.]
| IPQ takes its readers from:
● headlines to the forces driving them
● regulations to their underlying intent
● puzzle pieces to their interconnection
● rules to implementation pathways
● random data to critical trends
● the sidelines to shaping the future
● compliance problems to proactive tools
● information to strategic intelligence
IPQ’s “Monthly Updates” pull together the content that went online during the previous month and are an easy way for subscribers to keep up with the current critical developments impacting the quality regulatory process worldwide. Included are the news briefs on recent developments in the CMC/GMP arena, and an annotated listing of FDA drug GMP warning letters and recalls as well as EU GMP non-compliance reports (NCRs) posted during the month.
IPQ’s “News Alerts” provide links to the opening part of the stories and pp. 1-3 of the Monthly Updates when they are posted online. Subscribers can click through to the full stories/ monthlies and to the newly posted briefs, warning letters, NCRs, and recalls.