Agnes Shanley

Primary packaging and container design reflects a move to patient-friendly formulations and delivery systems.

As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.

The author discusses the results from TraceLink and Actionable Research's Global Drug Supply, Safety and Traceability Report.

Johnson & Johnson Supply Chain (JJSC) and the distributor AmerisourceBergen launched a four-week pilot program to test GS1’s EPCIS standards and to see how effectively data could be transferred between the two partners.

Longer packouts are becoming the rule, as logistics service providers and sponsors gain experience planning logistics for clinical trials involving novel therapies.

An example of a new cold chain temperature-controlled shipping technology is Cocoon, which was commercialized in November 2016 and designed for use with pallet-sized shippers.

Cloud-based information technology makes it easier for pharma companies and outsourcing partners to collaborate on quality, if risk-management steps are followed.

Gelatin is widely used for encapsulation, and requires close attention to “critical-to-quality” attributes.

Andrea Zobel, senior director of product management, clinical trial supply, and logistics at PAREXEL International, examines key issues and questions that sponsors and contract partners must address.

TraceLink’s first Drug Supply, Safety and Traceability Report suggests that 19% of pharma companies, 11% of distributors, and 9% of dispensers still haven’t begun to address lot-level serialization requirements. Only 20% say their CMOs will be ready for the November 2017 deadline.

As pharmaceutical quality metrics evolve, they will need to incorporate more of the principles of operational excellence, says consultant Prabir Basu.

Primary packaging and container design reflects a move to patient-friendly formulations and delivery systems.

Advances in cloud-based IT and user interfaces make it easier to collaborate, but a strong foundation, based on knowledge of data and risk management principles, is needed first.

PDA’s first aging facilities survey suggests that post-approval changes play a major part in slowing pharmaceutical industry investment in new technology.

In InstantGMP, cloud-based IT and an approach grounded in cGMPs, brings more of the power of paperless recordkeeping to manufacturers, at a fraction of the cost.

Could greater market transparency improve pharmaceutical quality and regulatory compliance?

Ensuring that materials have optimal critical quality attributes for the required formulations is crucial.

The pharmaceutical industry has weathered its share of “black swan” events.

Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.

In 2009, the International Pharmaceutical Excipients Council introduced an Excipient Information Package that includes a product requirement datasheet, site quality overview, and site and supply chain security overview.

Outcry against high pharmaceutical pricing brings questions of high R&D costs and restrictive payers, but also drug development and manufacturing efficiency.

Recent astronomical price increases have driven accusations that some pharma companies are price-gouging.

Pharmaceutical manufacturers and business partners are studying how Advanced Digital Ledger Technology might solve supply chain and other data transfer problems.

A number of organizations have analyzed and estimated the size of pharma’s counterfeit and diversion problem.

As criminals duplicate the latest overt security technologies, pharmaceutical manufacturers are evaluating covert and layered approaches to fight counterfeiting, theft, and illegal product diversion.

Analytics and quantitative approaches are shedding more light on these complex formulations, promising to improve process control and product design.

The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?

IPEC consultant Irwin Silverstein discusses third-party audits and regulatory compliance issues facing suppliers and their customers.

Analytics and science-based approaches are shedding more light on these complex dosage forms, promising to improve process control and product design.