Quality Systems

Elizabeth Joseph is research scientist II, BioPharma Solutions at Baxter Healthcare Corporation.

Articles

The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.

Residual Moisture Determination in Lyophilized Drug Products

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

An effective quality control unit is independent from manufacturing and ensures current standards are followed.

The Right Pieces for a Quality Program

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

FDA readies more efficient oversight processes while advancing collaboration with Europe.

More Consistent Drug Inspection System on Horizon

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

It is good industry practice to clarify the precise remit for each of the reviewers of a 
controlled document, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.


Signatures–What’s in a Name?

Unforeseen challenges can be avoided in technology transfer by evaluating the variety of processes involved.

Evaluating the Tech Transfer Process

The company is recalling Alprazolam Tablets, USP C-IV 0.5 mg because of potential presence of foreign substance.

Mylan Recalls Alprazolam Tablets

Dr. Reddy’s, Sanofi, and Perrigo Company issued voluntary recalls of ranitidine in October 2019 because of N-Nitrosodimethylamine contamination.

Three More Companies Issue Recalls Due to NDMA Impurities

The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process. 

FDA Publishes Drug Master File Guidance

The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.

FDA Publishes Guidance on User Fees

Sarah Hardison, head of Regulatory and Pharmacovigilance Solutions, Clarivate Analytics, will regulatory tackle trends in her presentation on the World of Pharma Podium during the second day of CPhI Worldwide.

Quality Assurance/Quality Control