Quality Systems

FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico.

FDA Discovers Microbial Contamination in Compound Pharmacy Products

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

The authors discuss three methods for identification of out-of-trend (OOT) results and further compare the z-score method and the tolerance interval in OOT analysis for stability studies.

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.

A unique demographic and payer mix make ASEAN an increasingly attractive region.

Siegfried Schmitt discusses the European Commission's (EC) guidelines on Good Distribution Practice of Medicinal Products for Human Use

The Taiwanese government engages in regulatory science in a move to boost its pharmaceutical sector.

An overview of the latest regulatory developments for malaria drugs, biosimilars, and global standards.

FDA addresses shortages of drugs needed to treat premature infants and patients unable to eat or drink by mouth.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products made from its facility in Ingelheim am Rhein, Germany.

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished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.

USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities.

The U.S. Pharmacopeial Convention is offering free online access to public standards to help ensure the quality of the herbal ingredients used in medicinal products.

Making the effort to apply new methods to pharmaceutical processing will bring benefits.

FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies.

New Center for Pharmaceutical Advancement and Training increases number of experts and available tools in Sub-Saharan countries.

The workshop will cover a proposed new method for measuring moisture vapor transmission rate.

EMA streamlines orphan drug application procedure.

Pfizer has launched a prescription-fulfillment website for Viagra tablets in an effort to combat the online sale of counterfeited medicine.

Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied.

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

New US patent rules change the playing field for open innovation.

Prior to price escalation of pharmaceutical products in Brazil, the country's regulatory authority released a study on price-cap control and its benefits in the past years.

Drug companies team up with INTERPOL to keep counterfeit medicines off the Internet and out of the hands of patients.

FDA faces budget crunch; Supreme Court hears key cases

The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.

A control strategy can maintain a low level of particulates, and thereby a low bioburden, in cleanrooms

FDA will use a new anticounterfeiting tool to detect fake medicines.

FDA issues draft guidance to minimize medication errors.