Quality Systems

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.

New therapies and tighter budgets challenge bio/pharma to think outside the industry.

Peter Stein, MD will present FDA’s keynote presentation at the CPhI North America conference on Thursday, April 26, 2018 in Philadelphia, PA.

Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.

Implementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.

The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications.

Taking vendor product data at face value puts pharmaceutical manufacturers and their supply chain partners at risk.

Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).

Telstar reports that its Boreas, a new 86° ultra-low-temperature freezer, increases average performance by 20%.

The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.

The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.

The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.

The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.

The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.

The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.

Sartorius Stedim Biotech has launched a new automated parallel bioreactor system for perfusion culture.

The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates.

A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft.