Jennifer Markarian

BioPharm International asked Andrew Bulpin, head of Process Solutions at MilliporeSigma, about the end-of-life options for disposable components of biopharmaceutical single-use systems.

Electronic systems can remove opportunities for individuals to make mistakes or to manipulate the data.

Optimize practices and meet requirements using electronic data integrity systems.  

The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.

Consider best practices for placing, maintaining, and calibrating temperature sensors.

A Q&A with PCI Pharma Services about best practices for choosing and maintaining temperature sensors in cold and cryogenic storage.

Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.

Material compatibility, material sourcing, facility layout, and training are crucial aspects of a successful disposable fill-finish system.

The Subcommittee for Advanced Manufacturing of the National Science and Technology Council highlights biopharmaceutical manufacturing as an emerging priority.

The challenge of achieving zero visible defects (i.e., particulates) in parenteral drugs will require a coordinated effort at all stages of the supply chain, particularly in the production and filling of primary containers.

Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.

A Q&A with SCHOTT Pharmaceutical Systems and West Pharmaceutical Services

BioPharm International spoke with INTERPHEX 2013 conference-session presenters to gain insight on trends in facility and process design.

The New Jersey-licensed specialty pharmacy recalls magnesium sulfate products and halts all production operations.

Product sold online in Malaysia and Indonesia infringes on the company’s trademark.

A GBI Research report says the opioid market will be driven by development of new products and post-marketing studies designed to reduce abuse risk.

Group sales were down, but R&D progress points to future growth.

Two general chapters on elemental impurities? limits and procedures are to become official Feb. 1, 2013, with implementation proposed for May 1, 2014.

Rutgers engineers constructed a direct compaction line in collaboration with Janssen.

Eli Lilly expects overall revenue growth in the coming year.

The US Supreme Court accepted an appeal by the Federal Trade Commission of a decision that upheld an arrangement of payments by Solvay Pharmaceuticals to generic drug companies to postpone introduction of generic versions of its branded testosterone-replacement drug.

GlaxoSmithKline announced its intent to increase ownership in its publicly-listed, consumer-healthcare subsidiary in India and in GlaxoSmithKline Consumer Nigeria as part of its emerging-markets investment strategy.

The Italian Medicines Agency lifted a temporary hold on the use of Novartis seasonal influenza vaccines in Italy after affirming the vaccines' safety and efficacy.

Pharmaceutical industry leaders Novartis and Merck—among others—released second-quarter 2012 results showing global sales down in third-quarter 2012, with growth in key pharmaceutical products helping to offset losses due to patent expirations.

New US Pharmacopeial Convention (USP) standards provide a universal approach to organizing labels for prescription containers dispensed by US pharmacists in an effort to improve patient understanding.

Merck will close its headquarters in Whitehouse Station, NJ and relocate to its existing facility in Summit, NJ, beginning in 2014.

Bayer expands animal health business with acquisition from Teva.

Pfizer and Mylan have agreed on terms by which Mylan may launch its generic version of Pfizer's Detrol LA (tolterodine tartrate) extended-release capsules, pending final approval by FDA.

The Observational Medical Outcomes Partnership (OMOP), which is managed by the Foundation, desires feedback on proposed research priorities and tasks.