Technical Reference File Update

June 03, 2022

As part of our on-going commitment to provide the latest technical updates and regulatory information regarding Lonza Capsugel® products, we have enhanced the Technical Reference File (TRF) for Capsugel® empty hard capsules to showcase technical and application related information, along with summarizing information concerning the composition, manufacturing, specifications, and testing of each of our products in one single document. The document provides access to relevant information and extractable annexes for quick reference for pharmaceutical developers, for quality assurance personnel, and for regulatory groups. 

As a result of this update, your product Certificates of Analysis and Product Specification Sheets will be adjusted to compliment the new version of the TRF. This includes:

  • Updated product specifications
  •  Removal of redundant test parameters
  • New, globally aligned test parameter method references
  • Additional compliance related text, where applicable

A detailed change log is available as an addendum the new TRF, providing context and justification for the changes being made.  

Steps to help you with the new TRF

To help you with the new changes, we would like to make access to the new TRF available to you now, before the official launch date of August 1, 2022.

To access the Technical Reference File, please use the following link to register. Once registered, the TRF and change log will be emailed to you within 3-5 business days.  

We appreciate your support to forward this announcement and information to the quality, regulatory, and other interested departments within your organization.  If you have any questions regarding this announcement, please contact your Account Solutions Representative.