Quality Systems

Crunch time is rapidly approaching in Roquette?s long-running patent dispute with SPI Pharma, with the case scheduled to go to trial on 4th October 2010.

Changes to Part 2 of the EU GMP guide will come into force by 31 July 2010 in order to bring it in line with the ICH Q9 guideline on Quality Risk Management. As a result, it will no longer be identical to the ICH Q7 guideline on APIs - a harmonised guideline for the US, Europe and Japan.

Last week, Senator Charles Grassley (R-IA) sent letters to 16 drugmakers, including Pfizer (New York), AstraZeneca (London), and Eli Lilly (Indianapolis), asking them about their current policies regarding whistleblowers?employees who file complaints under the False Claims Act (FCA).

A history of the selection of the widely used significance level leaves much to be desired.

To continue innovating, the biopharmaceutical sector needs support from all levels.

As generic divisions become the most-wanted acquisitions of Big Pharma, India's domestic industry may be thinning out.

The authors discuss the statistical tools used in experimental planning and strategy and how to evaluate the resulting design space and its graphical representation.

Reports of overlooked controls, dropped pallets, and misplaced documents leave a chill in the air.

After a spate of industrial disasters, the public seeks greater oversight of corporations-so does FDA.

More information may be released to improve public understanding of regulatory policies.

Pfizer Suspends Tanezumab Program; Actavis Appoints CEO; And More.

The US Food and Drug Administration issued on June 25 a draft guidance for industry, "CMC Postapproval Manufacturing Changes Reportable in Annual Reports," to provide recommendations to drug applicants about the types of changes that may be included in annual reports.

The Office of the Inspector General for the Department of Health and Human Services (HHS) issued a report, Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials, which evaluates the incidence of foreign clinical trials, the ability of the US Food and Drug Administration to oversee these trials, and recommendations to FDA on how to improve its oversight of foreign clinical trials.

Europe needs a more standardised and consistent approach for supplying excipient information to the regulators.

The effects of counterfeiting are hard to measure, both in human impact and financial loss.

The US Pharmacopeia recently convened a meeting of stakeholders to set goals for its 2010–2015 cycle.

X-ray powder diffraction (XRPD) is a versatile, non-destructive technique that reveals detailed information about pharmaceuticals.

With the increasing financial and technical means of counterfeiters, the number of counterfeit pharmaceuticals in the supply chain is growing at an alarming rate.

The 2D Data Matrix barcode is a familiar sight for most pharmaceutical manufacturers as printing is implemented to meet certain regulations.

We decided to dedicate this month's issue of PTE to a topic that affects all of our readers; the threat of counterfeit medicines.

In order to combat the threat of counterfeits in Europe, the EU's current anti-counterfeiting directive is being amended.

Counterfeit pharmaceuticals are complex products that can vary from their legitimate counterparts both chemically and physically.

Wyatt Earp, the legendary sheriff of Tombstone used to solve troubles in a simple way: aiming, pulling the trigger and bang! ... problem eliminated! Some manufacturers check the readability of their barcodes in the same way.

Teva Pharmaceuticals in the US has admitted to including false statements in the physician prescribing information for its oral contraceptive product Gianvi, a generic version of Bayer Healthcare?s YAZ oral contraceptive.

A study conducted by the European Medicines Agency (EMA) has shown that statistical methods using EMA's EudraVigilance database of adverse drug reaction reports can be used to detect drug safety issues "significantly earlier" compared with routine pharmacovigilance.