Development

Articles

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

EDQM Publishes New General Chapter in European Pharmacopoeia Supplement 10.3

The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces. 

Qualification of a Swab Sampling Procedure for Cleaning Validation

The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.

Sartorius Stedim Biotech Launches Consultancy Services for Viral Clearance Validation

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Ensuring the quality of data in process monitoring and control systems starts in process development phases. 

Building Data Quality In Generates Quality Data Out

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Regulators have exaggerated expectations for simulated media fills. 

Complications in Process Simulation Execution

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

The CuDAL-Excel program, based on Microsoft (MS) Excel, has been developed to calculate the United States Pharmacopeia (USP) passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios and for both immediate release and extended release requirements. The users can obtain the passing probability by simply entering the input variables, with wide applications for process validation/verification and batch release. As a user-friendly program, CuDAL‑Excel should bring more benefits to the industry practitioners than other existing programs/tools.


Determining the Probability of Passing USP Content Uniformity and Dissolution - Immediate and Extended - Tests with CuDAL-Excel

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.

Alternative Cleaning Validation Methods for Biologics

Agnes Shanley is senior editor of Pharmaceutical Technology.

Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as  inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.

FDA cites repeated, fundamental cGMP issues in its warning letter to Torrent Pharmaceuticals

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.

Balancing CMC Priorities

Rockwell Automation’s updated FactoryTalk AssetCentre software supports several new types of production assets.

Process Validation