Regulatory Oversight

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.

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.

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.

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

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

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.

Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.

Siegfried Schmitt of PAREXEL discusses regulation requirements for quality systems.

Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.

IBEF and Pharmexcil report the country?s plans for growth and its commitment to lowering the cost of medicines globally.

FDA is seeking a permanent injunction against a dietary supplement manufacturer following the company?s repeated distribution of unapproved drugs and adulterated dietary supplements.

Parameters for steam-sterilization autoclave overkill cycles should be chosen based on process understanding.

Vaporous hydrogen peroxide, nitrogen dioxide, chlorine dioxide, and carbon dioxide technologies can be used in pharmaceutical manufacturing to sterilize or disinfect.

During the ongoing federal government shutdown, FDA activities will be limited to work involving the safety of human life or the protection of property, and activities funded by carryover user fee balances PDUFA, GDUFA, and MDUFA.

The pharmaceutical industry grows despite conflict in the Middle East.

Foreign companies zero in on Myanmar with the hope of securing a foothold in its pharmaceutical market.

FDA publishes guidance on ANDA submissions.

EMA revises HIV treatment guideline.

Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.

EMA releases details of restructuring.

FDA updates guidance to reflect advances in technology.

Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.

Video recorded at Validation Week Canada

Prequalification of Sanofi Pasteur?s Menomune vaccine makes it eligible for purchase by United Nations agencies.

New FDA supply chain policies aim to strengthen inspection and oversight processes.