Quality Systems

Articles

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

Neostigmine Methylsulfate 5mL Recalled

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

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

Biosimilars Raise Manufacturing and Regulatory Challenges

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

Seeking Regulatory Advice

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

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.

Responding to FDA CAPA Requests (2018)

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.

Maintaining GMPs Requires Continued Vigilance

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

Purolite Launches New Protein A Resin

FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.

Data Integrity Issues Found at China Facility

The company’s next-generation ultraperformance liquid chromatography platform is designed to meet the evolving laboratory requirements for chromatographic performance.

Waters’ New UPLC Platform Meets Evolving Chromatography Needs

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.

Hospira Recalls Naloxone Hydrochloride

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

Quality Assurance/Quality Control