Blog 2 – September 2022
Technology Transfer – Regulations & Guidelines
There are few if any “rules and regulations” issued by regulatory agencies such as the FDA or EMA. There are probably several reasons for this, but high on the list must be:
- Technology Transfer is so varied that no set of rules or regulations could hope to cover all the combinations of processes, analytics and facilities.
- In the main Regulatory agencies tend to state what activities – such as equipment cleaning – need to be regulated and what standards these activities need to achieve, but they want to don’t regulate HOW these standards should be achieved.
- In order to achieve regulatory harmonisation, the agencies are instead increasingly adopting the regulatory guidelines introduced by the ICH (International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management – Annexes
Released for consultation. Discusses changes (with examples) to parameter classification (e.g. CPP, KPP) with enhanced process knowledge. I will cover this further when I cover CQA, CPP parameters.
ICH guideline Q10 on pharmaceutical quality system
This document describes a model and components of an effective quality management system for the pharmaceutical industry. It includes technology transfer activities as are part of knowledge management. It confirms that tech transfer is part of process performance, product quality monitoring system and change control system throughout the product lifecycle.
This describes tech transfer in terms of product and quality management, but this could be misleading as it places tech transfer between development and commercial and as we know transfer of commercial scale activities involves a great amount of tech transfer activity. It is concerned with quality and knowledge transfer not the practice of tech transfer.
World Health Organization (WHO) Technical Report Series, No. 961, 2011 Annex 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing
States that transfer of technology requires a documented, planned approach using trained and knowledgeable personnel working within a quality system, with documentation of data covering all aspects of development, production, and quality control.
It provides “guiding principles on transfer of technology [which] are intended to serve as a framework which can be applied in a flexible manner rather than as strict rigid guidance and concentrates on the organisational and documentation “recommendations” which would be required.
From my point of view – a good starting point and checklist but doesn’t really help with timeline of process flow.
This guideline is current being updated and is available as a draft document on the internet:
ISPE Technology Transfer Guide (third edition published December 2018)
The ISPE Technology Transfer Guide describes itself as being designed to provide a standardised process and recommends a minimum base of documentation in support of the transfer request, and to describe the appropriate information that needs to be compiled to support the transfer of the information and provide regulatory filing documents. It this it does what it says – concentrating on the documentation required but perhaps not showing how this interacts with the workflow of tech transfer.
It does however devote a significant amount of space to analytical technology transfer which is missing from most other guidance documents. In addition to this it covers API’s and a variety of different dosage forms but admits it doesn’t cover biologics which these days could be seen as a major omission.
PDA Technical Report 65 Technology Transfer (PDA, 2014)
Provides an overview of the technology transfer process. It “walks through” technology transfer process and while not providing a “roadmap” it does step through the main steps and describes the activities and responsibilities of each of the different functions clearly showing how each function interacts with each other as the technology process progresses. Indeed its stated purpose is to provide a “reference Guide to the Technology Transfer Activities and Deliverables” which it does well.
Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs (Replacement, Reduction and Refinement).
You may also consider:
1. Eudralex Volume 4 Chapter 7 Outsourced Activities (EudraLex Volume 4 Chapter 7, 2009)
2. Food and Drug Administration. 2011. “Guidance for Industry Process Validation: General Principles and Practices.”
3. EMA/CHMP/CVMP/QWP/BWP/70278/2012. 2014. “Guideline on Process Validation for Finished Products—Information and Data to Be Provided in Regulatory Submissions.”
4. ICH Q8R2
5. ICH Q9
6. ISPE PQLI guidelines