Simplifying Global Compliance
Drugmakers have 13 months to revamp how they track drugs after President Barack Obama signed into law a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
Congress rejected the FDA’s call for mandatory oversight of compounding pharmacies, passing legislation that instead allows compounders to volunteer for agency oversight. Read More
More than three years after Hospira’s Rocky Mount, N.C., plant was warned for lax quality control, prompting a painful manufacturing slowdown and a costly remediation, the drugmaker expects to near the “top end” of production capability in 2014, Hospira’s chief said last month. Read More
Drugmakers are pushing back on proposed EU GMP requirements that would expand safeguards against product cross-contamination, saying the proposed six-month timeline for implementation is unworkable. Read More
The FDA plans to shift its focus during facility inspections away from examining documentation, such as standard operating procedures, and place more emphasis on a facility’s operational metrics. Read More
A North Carolina pharmacy is recalling all of its sterile compounded drugs distributed within the Tar Heel State and ceasing production of sterile products altogether after an FDA site inspection. Read More
Merck KGaA’s Mexican subsidiary received a Form 483 for inadequately looking into a glass defect and not examining devices used in its products. Read More
The FDA chided OTC drugmaker Altaire for an inadequate response to numerous customer complaints of mold in the eye drop product carboxymethylcellulose sodium 0.5 percent ophthalmic solution, 30 mL. Read More
Sloppy investigations into various deviations such as hair in finished drug vials are outlined by the FDA in a Form 483 for OSO Biopharmaceuticals Manufacturing. Read More
Some drugmakers believe they have to test every batch, every time for every single metal to avoid any impurities in the final batch. Read More
When you greet an FDA investigator, do you ever wonder about his/her qualifications? Read More
Alexion’s recall and replacement of vials of its rare disease drug Soliris could cost the company between $10 and $25 million in the fourth quarter, the drugmaker says in an SEC filing last month. Read More
Tamper-evident packaging and registered product trademarks are two features Johnson & Johnson (J&J) employs to minimize a product’s risk of being counterfeited or diverted. Read More
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 – Fax (703) 538-7676 – Toll free (888) 838-5578.
Copyright ©2013. All Rights Reserved.
Design, CMS, Hosting & Web Development :: ePublishing