Helping Ensure Regulatory Compliance
West's Regulatory Affairs staff helps ensure that West's products meet the rigorous standards demanded by pharmaceutical industry regulations.  West’s regulatory program is administered from Corporate Headquarters in Lionville, Pa.

Regulatory Affairs staff members work closely with customers to help them understand the regulatory guidances and issues relevant to pharmaceutical administration systems, components and delivery devices. The Regulatory Affairs staff can provide customers with opinions on the regulatory impact of West's products.

The regulatory staff also communicates frequently with regulatory agencies so they have a thorough understanding of the various agencies' positions as they relate to West's and its customers' products.  

Click on the links below to read the relevant industry guidances for packaging:

• Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics
• Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice

To view a quick reference guide that connects relevant sections of current industry guidances and documents to specific issues related to the preparation of parenteral packaging components, click here. 

To read the May 18, 2005, FDA update on combating counterfeit drugs, click here.