Viewpoints

Mar 14, 2018
A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft.
Mar 02, 2018
Pharmaceutical Technology
FDA enforcement efforts and drug approvals trend upward.
Feb 02, 2018
Pharmaceutical Technology
Hospitals form not-for-profit drug company to combat drug shortages and high prices.
Jan 24, 2018
Viewpoint: The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation.
Jan 02, 2018
Pharmaceutical Technology
Bio/pharma professionals manage expectations amid industry uncertainty.
Dec 02, 2017
Pharmaceutical Technology
Is pharma up to the task of developing knowledgeable, motivated employees?
Dec 02, 2017
Pharmaceutical Technology
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Oct 19, 2017
By Pharmaceutical Technology Editors
How soon could the pharmaceutical industry see a widespread adoption of emerging technologies that are poised to shape its future?
Oct 02, 2017
Pharmaceutical Technology
Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Oct 02, 2017
Pharmaceutical Technology
Reeling from financial and tropical storms, Puerto Rico needs stable industry for recovery.
native1_300x100
lorem ipsum