Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells
The purpose of the Guideline for the Preparation of Technical Master Files for Blood, Blood Components and Haematopoietic Progenitor Cells 2008 is to assist manufacturers in the development of Technical Master Files relevant to blood, blood components and haematopoietic progenitor cells. The Guideline describes the scope, detail and depth of information required for Technical Master Files to demonstrate the safety and quality of blood, blood components and haematopoietic progenitor cells.
The 2008 Guideline is an updated version of the 2004 edition with minor editing changes, updated legislative references and the addition of target timeframes that the Blood and Tissues Unit will seek to meet in evaluating submitted Technical Master File.
Contents
- Purpose and introduction to the guideline
- Relevant documents
- Submission of a Technical Master File
- Evaluation and approval of Technical Master File
- Fees
- Changes to a Technical Master File
- Suggested content of a Technical Master File
- Appendix A - Technical Master File submission form