Manufacturing

Articles

GSK will close the Sligo, Ireland skincare product manufacturing site by 2021. 

GSK Plans to Close Facility in Ireland

The contract development and manufacturing organization will discuss its capabilities in topical drug products at CPhI North America, taking place April 24–26, 2018 in Philadelphia, PA.

Halo Pharma Simplifies Topical Drug Product Development and Manufacturing

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.

Using QbD in Topical Drug Manufacturing

Pharmco Laboratories received an FDA warning letter for significant violations of CGMP for finished drugs and APIs at its Florida, US facility as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products.

FDA Warns Pharmco Laboratories of CGMP Violations and Misbranding

David W. Osborne, PhD, is Chief Scientific Officer and Founder, Independent Derm Solutions, LLC, 4215 Creekside Court, Fort Collins, CO 80525.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

Impact of Quality by Design on Topical Product Excipient Suppliers, Part II: Reasonable Expectations

This article will equip the excipient vendor with an understanding of QbD from the perspective of the topical pharmaceutical product manufacturer.

Impact of Quality by Design on Topical Product Excipient Suppliers, Part I: A Drug Manufacturer's Perspective

Tapemark, a full-service CDMO specializing in transdermal, oral thin film, and topical drug-delivery technologies, is exhibiting at CPhI.

Tapemark Showcases Transdermal, Oral Thin Film, and Topical Drug-Delivery Systems at CPhI

Rong-Kun Chang is master chemistry reviewer, Division of Liquid-Based Products at FDA’s Office of Life Cycle Products, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research.

Susan Rosencrance is director, Office of Lifecycle Drug Products, at FDA’s Office of Life Cycle Products, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research.

Bing Cai, PhD, is acting director, Division of Liquid-Based Products at FDA’s Office of Life Cycle Products, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research.

Pahala Simamora is acting branch chief, Division of Liquid-Based Products at FDA’s Office of Life Cycle Products, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research.

Andre Raw, PhD, is senior scientific and policy advisor at FDA’s Office of Life Cycle Products, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research.

The authors of "Common Deficiencies in ANDAs for Dermatologic Drug Products" provide some examples of commonly cited deficiencies cited by FDA.

Commonly Cited Deficiencies for Topical Dermatologic Drug Products in ANDAs

The company expanded its topicals capacity with an investment in the Becomix RW30 model homogenizer.

Juniper Pharma Services Expands Topicals Capacity

Agnes Shanley is senior editor of Pharmaceutical Technology.

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.

Manufacturing, Topical Drugs