​Lonza 2023 Technical Reference File for Capsugel® empty hard capsules

July 05, 2023

27 April 2023

We are excited to share a version update of our Technical Reference File (TRF) for our
Capsugel® empty hard capsule products. As a company committed to providing the latest
technical updates and regulatory information, we believe that this new version will be an
invaluable resource for our customers.

The TRF is an assembly of technical and application-related information that summarizes
the composition, manufacturing, specifications, and testing of each of our products in one
single document. It provides access to relevant information and extractable annexes for
quick reference for pharmaceutical developers, quality assurance personnel, and
regulatory groups.

This year's release features minor updates and revisions, including corrections to typos
related to dimensional targets and testing methods. We've also reformatted product
specification and defect classification tables to more clearly indicate quality attribute and
quality level applicability and criteria.

We expect these updates to have minimal impact for the majority of our customers;
however, we recommend a review of the revision log and performing any necessary impact
assessments. You will receive the detailed revision log alongside the 2023 TRF once you've
registered using the link below.

We would like to offer early access to the 2023 TRF before its official effective date of
August 7th, 2023. Please use the following link to register and receive the TRF within 3- 5
business days.

We appreciate your support in forwarding this announcement and information to the
quality, regulatory, and other interested departments within your organization.

If you have any questions regarding this announcement please do not hesitate to contact
your Account Solutions Representative.

Thank you for your continued support.