IPEC Insider Archive

USP Delays Deadline for Industry to Comply with Elemental Impurity Standards

USP has decided to delay the implementation of two general chapters on elemental impurities until ICH has further established its own impurity testing requirements.

source: in-PharmaTechnologist.com

IPEC-Americas Foundation Kicks Off 'Summer Fundraising Campaign'

IPEC-Americas Foundation Chairman Robert G. Pinco, R.Ph., Esq., is pleased to announce the IPEC Foundation's "2013 Summer Fundraising Campaign!" This effort is designed to enhance awareness of the work of the Foundation, as well as to...

source: IPEC-Americas

10th Annual Science & Standards Symposium — Partnering Globally for 21st Century Medicines

Co-sponsored by USP, the Chinese Pharmacopoeial Commission (ChP) and the Drug Information Agency (DIA) Join USP, ChP, DIA and international leaders in academia, government and industry for science-driven discussion that...

source: IPEC-Americas

USP Appoints Members to the Elemental Impurities Implementation Advisory Group

USP forms and appoints members to the Elemental Impurities Implementation Advisory Group. Dr. Roger Williams, EVP–CEO and chair, Council of Experts, has appointed nine individuals to the Elemental Impurities Implementation...

source: IPEC-Americas

IPEC-Americas Excipient GMP Auditing Workshop

Oct. 22 – 24, 2013 Space is limited to 20 participants — register now! Workshop Overview Assessing GMPs for Excipient Manufacture Where GMPs Begin Audit Planning Pre-audit Questionnaires Alternative Audit Approaches Audit Checklists & Techniques Necessary Auditing...

source: IPEC Insider

IPEC-Americas Journal of Excipients and Food Chemicals

IPEC-Americas sponsors and publishes a peer-reviewed quarterly journal related exclusively to excipients entitled "The Journal of Excipients and Food Chemicals." The Journal publishes original research manuscripts, opinion and commentary, as well as technical notes on topics...

source: IPEC-Americas

USP Town Hall Webinars – Resolutions Updates Concerning USP's Support and Advancement of Global Public Health Initiatives

USP Convention President, Dr. Timothy Franson and USP staff experts will conduct a WebEx update on USP Resolution 4. Resolution 4 focuses on the support and advancement of global public health initiatives....

source: IPEC-Americas

Save the Date: ExcipientFest Asia, Beijing Nov. 19-21

A Two-Day Educational Experience and Pharma Expo with In-Depth Workshops & Education Sessions from Industry's Top-Excipient Experts Including: Educational Sessions – Speakers and presentation topics to be announced soon! Full-Day Workshops – Speaker...

source: IPEC-Americas

How Big Pharma Drives Up Medicare Spending Without Improving Seniors' Health

The Medicare Part D prescription drug program for seniors wasted $1.4 billion paying for brand name drugs that were no more effective than their cheaper, generic counterparts, according to a new study by the Veterans Affairs...

source: Thing Progress

Pharmaceutical Maker Demands Mutual Inspection Standards with EU

Turkish pharmaceutical company Deva said the prolonged inspections of pharmaceutical products exported to the country's major trade partner, the EU, undermine the development of the domestic pharmaceuticals market.

source: World Bulletin

Generic Drug Manufacturer Ranbaxy Spends $300 Million to Improve Safety

Indian generic giant Ranbaxy said it has spent over $300 million to overhaul its operations and ensure no repeat of drug safety violations that led to a multimillion-dollar U.S. fine. New Delhi-based Ranbaxy recently pleaded...

source: Agence France-Presse via Industry Week

FDA Issues Draft Guidance on Contract Manufacturing

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products. FDA has issued draft guidance, Contract Manufacturing Arrangements for Drugs:...

source: PharmTech.com

Fine Chemicals Diversify

"The major part of fine chemicals is, and will always be, pharma," says industry consultant Jan Ramakers. Nearly 70 percent of the roughly $100 billion-per-year market for fine chemicals is in active ingredients and intermediates for pharmaceuticals. In recent years,...

source: Chemical & Engineering News

Obamacare Will Bring Drug Industry $35 Billion in Profits

Despite expiring patents on blockbuster drugs and a wave of new regulation from the Affordable Care Act that will cost drug makers, the pharmaceutical industry will reap between "$10 billion and $35 billion in additional profits...

source: Forbes

USP Excipients Stakeholder Forum Scheduled for June 7, Rockville, Md., and via the Web

The United States Pharmacopeial Convention (USP) will be holding the first Excipients Stakeholder Forum on June 7 at USP's Rockville, Md., headquarters. To expand the opportunity for stakeholder participation, USP will offer...

source: IPEC-Americas

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