Quality Systems

FDA cites cGMP violations and data-integrity issues and raises concerns over the company's ability to implement a robust and sustainable quality system.

PharmaCheck, a portable tool designed to detect poor-quality medicines, has been selected by Scientific American as one of the magazine?s World Changing Ideas of 2013.

Siegfried Schmitt, principal consultant at PAREXEL, discusses the state of drug manufacturing in India.

The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).

The rising cost of drug development and the decreasing proportion of drug-naive population in the US and European markets are driving international pharmaceutical companies to consider emerging markets as a location to conduct their clinical trials. Asia stands out among the emerging markets given its double-digit growth rates.

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

Brian Galliher of Cook Pharmica discusses visual inspection systems.

The industry lacks an accepted method for establishing a minimum incubation time (MIT) of less than seven days for biological indicators (BIs). The authors propose an MIT method that provides a means for reproducible determination of BI grow-out time.

Industry experts discuss the application, challenges, and benefits of a quality-by-design approach to sterile manufacturing.

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.

A review of this year's crop of the new molecular entities and new biologics license applications approved by FDA thus far in 2013.

Drug Quality and Security Act gives FDA authority over compounding pharmacies.

The international “Fight the Fakes” campaign will raise awareness about the dangers of counterfeit medicines.

Baxter has issued a voluntary recall of one lot of nitroglycerin in 5% dextrose injection after particulate matter was found in one vial.

Mylan and the Indian biopharmaceutical company Biocon receive approval for a biosimilar version of trastuzumab in India. Also, Mylan and Teva reach settlement on Copaxone in the EU.

European Medicines Agency announces the launch of the Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE) project.

An operational-excellence initiative increased collaboration between operations and quality personnel to address human-error-caused deviations.

The Drug Quality and Security Act creates national standards for serialization of drug products to protect against counterfeiting.

USP issues call for candidates for its 2015-2020 Council of Experts.

Breakthrough Therapies Raise Manufacturing Issues

FDA Moves to Curb Drug Shortages

Biotechnology Industry Organization President James Greenwood writes senators in support of Start-up Jobs and Innovation Act.

Includes a new approach on developing antibacterial agents targeted against multidrug-resistant (MDR) pathogens where patients have very limited or no remaining treatment options.

FDA releases guidance on pulmonary tuberculosis drugs.

Novasep?s European manufacturing sites in France and Germany pass FDA audits.

EMA and FDA publish joint QbD guidance on design space verification.

New regulation offers patients in Brazil greater access to experimental drugs.

The European Pharmacopoeia Commission has decided to change its approach on elemental impurities.

Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.

Sterilization validation must be based on a robust, quality-by-design philosophy; autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters, even when using overkill sterilization.