The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.
The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.
The agency announced two research collaborations on bulk lists, updates to categories of bulk drug substances, and issued a warning about a bulk drug substance used in compounding.
Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.
Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
The company’s new LCMS-9030 system is designed for high resolution and accurate mass detection.
The company unveiled its latest innovations to its mass spectrometry portfolio at ASMS in San Diego.
The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.
Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.
Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
BioPharm International asked an FDA spokesperson how the agency plans on handling these issues in the future.
The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.
FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.
The company’s next-generation ultraperformance liquid chromatography platform is designed to meet the evolving laboratory requirements for chromatographic performance.
Legislators have requested that FDA do more to prevent drug shortages.
An understanding of the unique nature of single-use systems, and how they interact with each biomanufacturing process, is important when qualifying single-use systems.
Industry experts discuss how to address extractables and leachables in single-use systems and the challenges in qualifying equipment.
Robust materials management, supplier quality management, quality control, and business continuity planning are essential to ensure continuous supply of single-use bags.
Biosimilars and biobetters have their own unique manufacturing strategies and challenges.
Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.
Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.
The company is recalling two lots of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system due to particulate matter on the syringe plunger.
