Quality Systems

Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.

FDA seeks more efficient testing to spur development of less costly biotech therapies.

Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.

Pharmaceutical Technology spoke with Sharon Ayd, executive vice-president of Pre-approval Pharmaceuticals and chief scientific officer at Regulatory Compliance Associates, about developing a corrective action and preventive action (CAPA) plan.

Maintaining good quality control practices throughout the entire manufacturing process requires robust development, a drive toward product and process understanding, and pre-established, comprehensive written procedures that are consistently reviewed and updated.

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.

The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.

The approval is intended to increase patient access to treatment for opioid addiction.

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

Legislators have requested that FDA do more to prevent drug shortages.

Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.

The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

The International Society of Pharmaceutical Engineering (ISPE) is field-testing the design principles of a comprehensive, industry-led program of self-evaluation of pharmaceutical quality that will align with the purpose of FDA’s quality metrics.

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.

The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.

EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.

PDA reviews an industry survey of concerns and best practices regarding the EU GMP’s required PUPSIT test for filters used in sterile filtration.

Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

FDA and Congress seek to limit the production and distribution of pain medicines.

This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.

By minding knowledge gaps, bio/pharma companies can avoid development pitfalls.