What are the regulatory guidelines for technology transfer?

What is technology Transfer

Technology transfers is the transferring of knowledge, systems, processes, and products from one site or organization to another. It is a legal and systematic approach that defines the role of each site in the entire product life cycle, supported by relevant documentation, regulatory approvals, and necessary facilities.

Technology transfer can occur between different types of pharma business operators until they follow the required processes and relevant regulatory regulations.

Sending Unit and Receiving Unit

There are two main entities during the technology transfer process in pharma industry, irrespective of the business operations type – Sending Unit and Receiving Unit

The sending unit transfers the intended process, product, or development to the Receiving Unit . The sending unit is primarily responsible for developing and transferring all the relevant necessities, such as documentation, technology, training, and manufacturing processes.

The receiving Unit is the entity where the sending Unit transfers the desired product or technology. The receiving Unit must be able to perform all parts of the transferred technology or process independently, within quality and/or regulatory regulation limits.

The sending and receiving Unit can be under the same organizations or be under different organizations. Within the same organization, the technology transfer occurs between its R&D and manufacturing site.

Whereas under different organizations, technology transfer occurs between the R&D lab and Contract Manufacturers for commercial-scale production

What is included in the technology transfer?

Technology transfer in the pharma industry is a comprehensive activity that involves carefully selecting all components of the entire product cycle. If not chosen critically, the technology transfer process could fail and/or face regulatory fines.

Some steps involved in a typical technology transfer include, but are not limited to

Planning

Planning is the critical stage of technology transfer that defines the transfer's goals, and what route it will take during the entire technology transfer.

In this stage, decisions such as

· What involves the technology transfer, i.e., manufacturing, packaging, or analytical methods

· Need for technology transfer

· Target market

· Responsibilities of the Sender Unit and Receiving Unit

· Expectation from the receiving unit

Any other areas that justify the need for technology transfer are included, and forms the basis of the entire transfer process

Capabilities Assessment

In this step, the capabilities of the receiving Unit are assessed. It is determined whether it can fulfill all requirements and manufacture products as per the sending unit recommendation and quality standards. The assessment is carried out regarding all aspects of pharma manufacturing stages.

The main aim of the assessment is to highlight any issues before the technology is transferred and resolve them to prevent problems and faults in the product.

For example,

· The sending unit assesses the RU regarding equipment and suggests improvement, such as overhauling of equipment or adding a new one.

· Evaluating the RU's capability to handle, quality issues and how they can resolved.

After the assessment is complete, the team submits its recommendations, which form the basis of whether the RU can handle the technology transfer.

Analytical Assessments transfer

Analytical assessment include the analytical function involved in the pharma process. It focuses on implementing analytical strategies, and it intends to fulfill the analytical requirements,

The sending unit must transfer all the analytical methods and relevant information to the receiving unit. The SU is also responsible for providing training, assisting in testing, defining all product-specific testing procedures, sampling methods, acceptance criteria, validation reports and equipment details specific to every analytical process, and approved procedures.

The RU is responsible for its responsibilities, such as reviewing analytical procedures & acceptance criteria, necessary equipment availability, adequate trained personnel, documentation system, validation, and approval for transfer reports.

The analytical assessment transfer should be made through a comprehensive document, often called "Analytical Procedures Transfer Protocol," and includes the following

· Scope and objective of sending and receiving unit

· Materials and methods specifications

· Experiments and their acceptance criteria

· Relevant documentation, such as results and report forms

· Procedures outlining how deviations would be handled

· Test samples, including starting material, intermediates, and finished products

Manufacturing Process function

The manufacturing process function decides the manufacturing part and production planning of the technology transfer. Critical parameters of the batch, such as batch size, unit operations, and material handling, are defined.  It aims to ensure product specification and quality consistency during the entire production life cycle in the receiving unit.

In this step, the manufacturing steps description, such as master batch records that RU will employ after technology transfer, is provided. It also includes In–process hold item qualification, order & method of addition of raw material, and how the bulk will be transferred during different manufacturing steps. The sending unit reviews all these steps in a master batch record for consistency, adherence, and compatibility.

Regulatory function

The regulatory function is devised to transfer the regulatory knowledge to the receiving unit to fulfill all the regulatory requirements. The technology transfer must identify and fill all related gaps with appropriate actions.

It is also responsible for interacting with the regulatory bodies during their routine visit to satisfy them with all available documentation and present actual practices.

Quality function

The role of quality in technology transfer is to ensure the highest quality standards and compliance by using appropriate tools, such as risk assessment and compliance.

The quality function transfers all quality & analytical functions, such as testing procedures, documentation, area requirements, and sample handling, by using different strategies. These strategies are selected based on risk assessment.

The sending and receiving unit are responsible for their specific activities and processes, which are described  earlier in the analytical section of this article.

Documentation

It includes all relevant documentation during each phase and activities. The selection of documentation involves various factors, such as the process and regulatory requirements.

For example, the documentation required for technology transfer can include the following

· Drug master file

· API master file

· Material safety data sheets

· Product development report

· Formulation development reports

· Master Formula

· Master of executed batch record

· Scale-up information

· Packaging material specification

· Master record of executed packaging record

· Validation

· Sampling plan

· Acceptance of quality level for products and defects

· Analytical test procedures

· Analytical procedure development

· Analytical procedure validation

· Standard test procedures

· List of equipment and instruments

· Preventive maintenance information

· Cleaning validation master plan

· Cleaning procedure development and cleanability

· Recalls and complaint reports

· Bio-batch information

· Pilot batch information

· History of changes and change management

Training during technology transfer

Technology transfer should also include the training process for the personnel at the RU facility. It helps ensure pharma operations consistentency with the sending unit policy and requirements.

A training plan must be developed for all the relevant areas of technology transfer. The RU is responsible for arranging & managing training by writing a training plan and obtaining its approval. The Sender Unit is responsible for providing the specific training for which technology is being transferred.

Technology Transfer Report

As the concluding part of technology transfer, a report is prepared to document all the underlying processes involved. It should include the details of the specific technology transferred, relevant procedures, acceptance criteria, results, and a conclusion.

What are the Regulatory guidelines, such as FDA & WHO, for the technology transfer

Market specific guidelines enable manufacturers to keep their processes within limits, and technology transfer being no exception. Following is the brief overview of FDA and WHO guidelines

United States FDA

There are no specific guidelines related to technology transfer by United States FDA. However, technology transfer is included in the quality management system, i.e., Q10 Pharmaceutical Quality System, as a part of the quality system to enhance the quality of pharma drug products, with technology transfer being one of its components.

Some brief descriptions of the technology transfer include, but are not limited to,

· Technology transfer is the transfer of new products through manufacturing. The transfer is within manufacturing sites or between manufacturing and testing sites.

· Its goal is to transfer knowledge between development & manufacturing, which forms the basis of the manufacturing process, control strategy, process validation approach, and ongoing continual improvement.

· Monitoring indicates process performance and integration into manufacturing.

· Corrective and Preventive Actions – CAPA can be used as an effective method for feedback and continual improvement

· The change management should provide details of all changes and process adjustments during technology transfer activities.

· Management review should be performed to ensure development can convert to commercial scale.

World Health Organization – WHO

The WHO guidelines for technology transfer are "WHO guidelines on technology transfer in pharmaceutical manufacturing." In these guidelines,

· The basic definition of technology transfer and all of its sub-parts, components, and processes is mentioned

· Gap analysis in RU and SU, assessing the preparedness of RU, performed by a qualified team and covers the capabilities and resources related to personnel, premises, equipment and instruments, utilities, cleaning, quality control, documentation, computerized systems, Qualification, validation, and further health, safety and environment-related considerations, including waste management.

· Organization and management

· Quality management and quality risk management

· Relevant documentation required during the technology transfer process

· Equipment and instruments responsibilities w.r.to SU and RU

· Determination, selection, and process of Qualification and validation

· Phases of a technology transfer project

About the Author:

Muhammad Asim Niazi

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.