Resources

Quality inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates. Q: My company is a contract manufacturer....

Contract manufacturing organizations that manufacture traditional and biotech pharmaceutical products are responsible for performing investigations and reporting the results to their clients. But how do biologics consultants recognize the differences...

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates® (RCA), and Steven J. Lynn, executive vice-president of Pharmaceuticals for RCA, discuss the verification of compendial methods. Q. Are compendial...

Q: I am in charge of GMP training for a contract-manufacturing site with approximately 350 employees. The budget for my department was recently cut, and now I am struggling to...

A well-functioning Corrective and Preventive Action (CAPA) program can make the difference between a deviation being corrected and prevented the first time. The consequence is reoccurring deviations that require reopened...

Understanding the similarities and differences between ISO 13485:2016 and CFR 21 Part 820 is a key step toward creating and/or maintaining a robust and comprehensive global Quality Management System (QMS).