What are Manufacturing & Technology Transfer?

Manufacturing & Technology Transfer both concern production site changes but focus on different product life cycle stages.

Manufacturing Transfer refers to the relocation of the production of human or veterinary pharmaceutical products from one manufacturing site to another.

This relocation can occur within the same company or between different companies and occurs at some point in the life cycle of most products, spanning development and scale-up to manufacturing, production, launch, and the post-approval phase.

Technology Transfer refers to the exchange of product and process knowledge between development and manufacturing, as well as within or among manufacturing sites, to achieve successful product realisation.

The effectiveness of a Technology Transfer is essential to ensure product quality, regulatory compliance, and sustaining business continuity. It serves as the foundation for the manufacturing process, control strategy, process validation approach, and continuous improvement initiatives.

All transfer processes must adhere to Good Manufacturing Practices (GMP) and align with relevant regulatory guidelines to ensure ongoing compliance with required quality standards.

Click here for information from the European Medicines Agency (EMA) on GMP guidelines.

Successful Manufacturing & Technology Transfer requires planning, collaboration among stakeholders, and the fulfilment of specific minimum requirements, including:

Development of a project plan covering all quality aspects, based on the principles of quality risk management.
Verification that the capabilities of both the Sending Unit (SU) and Receiving Unit (RU) are comparable (not necessarily identical), and that facilities and equipment can operate based on similar principles.
Conducting a thorough technical Gap Analysis between the SU and RU, encompassing technical risk assessment and identification of potential regulatory gaps.
Availability of adequately trained staff at the RU or provision for training, as necessary.
Consideration and consistent interpretation of regulatory requirements in the countries of the SU and RU, as well as any countries where the product is intended to be supplied, throughout the transfer process.
Assessment and assurance of the effective transfer of process and product knowledge.

Click here for comprehensive information on transfer activities from the World Health Organisation (WHO).

Why choose Aegisana’s Manufacturing & Technology Transfer services?

A thorough & committed approach.

Our GMP Compliance team is fully experienced with Manufacturing & Technology Transfer projects and can provide an expert support service to ensure your transfer planning, process and evaluation are efficient and successful.

Typical areas we can provide support with include:

Ensuring the transfer of all Master Batch Records (MBR) documentation concerning the specification steps and conditions for Manufacturing Transfer to the receiving unit.
Ensuring all Quality Control (QC) and Quality Assurance (QA) Procedures are transferred and implemented effectively.
Implementing robust Change Control procedures to manage any modifications or improvements to the transferred technology.
Conducting a thorough risk assessment to identify potential challenges and issues associated with Technology Transfer.

A real transfer support partner.

Supported by a robust Quality Management System (QMS), we can seamlessly and efficiently support your site change requirements.

Our goal is to provide you with peace of mind and confidence by providing an expert support service for complete compliance and safety, minimising or eliminating any disruption to product production.

Through effective communication, reliability, and trust, we aspire to establish a successful and robust strategic compliance and auditing partnership throughout the production of your human and animal products.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.