PTSM: Pharmaceutical Technology Sourcing and Management-04-01-2015

Xcellience receives approval to handle both analytical and manufacturing of DEA Scheduled products.

A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.

As an affiliate member, TraceLink brings serialization expertise to the Pharma & Biopharma Outsourcing Association.

Implementing serialization on a packaging line requires a complex integration of hardware and software and often requires that new and existing systems work together.

PDA’s new technical report provides a template for bio/pharma companies to follow to establish a risk-based approach to prevent drug shortages.

Small- to medium-sized companies are expected to drive near-term growth of the global biomanufacturing outsourcing market.

Temperature-controlled packaging trends include prequalified systems that simplify adoption, reusable systems that are more sustainable, and new temperature-monitoring technology.

Capacity expansions require staff expansions, and skilled, experienced staff, at all levels, are simply becoming increasingly hard to find.

FDA has concluded that Kemwell’s facility, systems, and practices comply with FDA’s requirements and no observations were reported on Form 483.

Recipharm expects to be rolling out further serialization projects during 2015.

The investments made in analytical and process development equipment will enable Laurus Synthesis to offer chemistry services to its clients.

UPS expands its special commodities program to more countries.

Sharon Johnson, senior vice president, Global Quality & Regulatory Affairs, will head the organization.

The manufacture and scale up production mark a significant milestone in the commercialization route of Nanobiotix lead product, NBTXR3.

Dr. Reddy’s announced that it expanded its facilities to include a formulation development laboratory at its Miyapur, Hyperabad, India plant.