Quality Systems

The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.

FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.

The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

The European Pharmacopoeia Commission has approved a general monograph laying down harmonized requirements for LBPs for human use and two general chapters addressing microbiological contamination of LBPs.

A new report gives an overview of the work of the International API Inspection Program.

Premier Pharmacy Labs is voluntarily recalling multiple products because of the potential lack of sterility assurance.

The Parenteral Drug Association’s Data Integrity Task Force helps industry members understand regulatory requirements for data integrity.

FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.

The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

The contract manufacturing organization’s facility in Boulder, CO, has passed general inspection from FDA.

The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.

The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.

The agency’s plan outlines its approach to implementing medical product programs and the use of financial resources.

A new book by Robert Thomas, principal consultant at Scientific Solutions, provides a training tool for novices and inexperienced users of plasma spectrochemistry as well as for supervisors and senior management who want to better understand the analytical issues. Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide, published on Feb.

Designing a mechanical integrity program using existing best practices can help pharmaceutical manufacturers comply with OSHA’s standard for process safety management.

How warehouse execution systems can help in case of a drug recall.

The company is recalling Pasta De Lassar Andromaco zinc oxide diaper rash treatment after FDA analysis confirmed the product contained high levels of yeast, mold, and bacteria.

The agency has release a report providing an overview of steps taken to enhance benefit-risk assessment in the review of drugs.

The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.

Pharma 4.0 envisions highly efficient automated processes, which could be continuous, batch, or a hybrid of these, driven by an integrated manufacturing control strategy.