New Version of WHO Guidelines on Process Transfer Published as a Draft

The WHO has recently published a new version of its guidelines on the transfer of technology as a draft. The draft originally dates back to 2020 and was presented at the 65th meeting of the Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) in October 2021. The version valid until now dates back to 2011 and is part of the WHO Technical Report TRS 961 as Annex 7. Since then, some changes in the guideline landscape, such as Data Integrity, Quality by Design and State of Control, have emerged, so that a revision of the WHO document on the transfer of technology in pharmaceutical manufacturing was deemed useful.

Many new chapters have been added to the previous document.

1. Introduction
2. Scope
3. Glossary
4. Due diligence and gap assessment
5. Organization and Management
6. Quality management and quality risk management
7. Documentation
8. Premises
9. Equipment and instruments
10. Qualification and validation
11. Product life cycle and project management principles
12. Phases of a technology transfer project
References, Further reading, Abbreviations
Appendix 1. Example of documentation commonly required for the transfer of technology

The chapters 'Due diligence and gap assessment', 'Product life cycle' and 'Project management principles', 'Life cycle approach', as well as the chapter 'Phases of a technology transfer project' and the appendix with sample documents are new and will certainly be of great interest. Furthermore, the inclusion of Quality Risk Management (chapter 6) is new. The chapters on Premises and Equipment have been split up as individual chapters. The chapter "Production: transfer (processing, packaging and cleaning)" has been removed and its content redistributed to the other chapters.

The guideline applies to the transfer of development products as well as to the transfer of marketed products (site change).

The new chapter on due diligence and the gap analysis is, as mentioned, new, but also very short. It states that a close review of the circumstances and documentation should take place through visits to the transferring and receiving site, and that the Quality Units of both sites should be involved. This review should be done before the start of the transfer.

The new chapter 'Life cycle approach' is also very short. It mentions that the life cycle status of the equipment, instruments, product and process should be taken into account in terms of control strategy and process validation. The responsible persons should monitor the progress of the transfer project.

In the new chapter 12 'Phases of a technology transfer project', the individual phases of a transfer project are mentioned:

• Phase 1: Project initiation
• Phase 2: Project planning
• Phase 3: Project transfer execution
• Phase 4: Project review and closeout

The 'feasibility phase' - usually mentioned in many transfer projects or transfer plans - is not explicitly mentioned here, but is included in Phase 1: Project initiation. The further project phases list who (receiving or delivering site) has to deliver which documents, information, activities.

The new appendix is helpful. It shows in a tabular form on two pages which documents are required or should be exchanged in the context of a transfer.

The new draft version with document number QAS/20.869/Rev1 can be found on the website of the WHO under 'current projects for medicines quality assurance'. Comments can be submitted until 1st June 2021.