Drug GMP Report

FDA Commissioner Margaret Hamburg, testifying April 13 before the House Energy and Commerce Subcommittee on Oversight and Investigations, told lawmakers the agency needs “additional authorities” to do its job properly.

A long string of OTC recalls and production issues has hurt Johnson & Johnson’s (J&J) bottom line and will further affect product availability, the company revealed April 19.

Foreign supplier reliability and the difficulty of managing recalls are top concerns for drugmakers working to control their supply chains, attendees at a recent conference said.

The FDA April 4 announced the launch of a website for consumers to search and view product recalls.

The International Pharmaceutical Excipients Council (IPEC) and the FDA recently announced they will be working together to create a library of pharmaceutical excipients.

Consumer products giant Reckitt Benckiser (RB) has received an FDA Form 483 with observations related to building sanitation, quality control and recordkeeping practices.

A Form 483 handed to Jacobus Pharmaceutical includes observations related to the company’s laboratory controls, facilities and production systems.

Excellium Pharmaceuticals’, Fairfield, N.J., facility has received a 16-observation Form 483, noting that investigations into production discrepancies did not extend to other products that might have been affected.

Teva Pharmaceutical and Taro Pharmaceutical have resolved GMP violations at plants in California and Canada, respectively, the companies said this week.

Under a new pilot program, NDAs submitted to the FDA and European Medicines Agency (EMA) with Quality by Design (QbD) components will undergo parallel review from both regulatory agencies.

The FDA has cleared Perrigo of its manufacturing woes following a warning letter last year to the company’s Allegan, Mich., site, opening the door for additional product approvals and export licenses.

The FDA has handed active pharmaceutical ingredient (API) manufacturer Ningbo Smart Pharmaceutical a warning letter for “significant deviations” from cGMP requirements.

The FDA is working with the European Medicines Agency (EMA) and Australia’s Therapeutic Goods Administration (TGA) to finalize a permanent pilot program for joint GMP inspections at active pharmaceutical ingredients (APIs) manufacturing facilities.

A final FDA guidance on request for designation (RFD) of hard-to-classify combination products will help inform sponsors of what information should be included.

The FDA’s rollout of a track-and-trace system to make it easier to identify counterfeit and other substandard prescription drug products should be structured as a supply chain-wide pilot program, AstraZeneca says in comments on the agency’s proposal.

The FDA has issued a MedWatch warning and a letter to healthcare professionals warning Teva Pharmaceutical’s generic lansoprazole delayed-release orally disintegrating tablets (ODT) can block oral syringes and feeding tubes.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has created a new website detailing company-led recalls for drug products.