Technology Transfer of Analytical Testing Methods: Purpose, Challenges, and Best Practices

Technology Transfer of Analytical Methods in Pharmaceuticals refers to the systematic process of transferring validated analytical methods from one laboratory (e.g., R&D, method development lab) to another (e.g., quality control, manufacturing site lab), ensuring the method performs equivalently and reliably at the receiving site.

Analytical Method Transfer 

Analytical Method Transfer, also known as Technology Transfer or Tech Transfer, is the process of transferring analytical methods from one laboratory (the sending site) to another (the receiving site) using an approved protocol. This collaborative effort between Quality Control and Analytical Research ensures that the receiving lab can accurately perform routine testing and product release using the transferred method. The sending lab, as the method owner, is responsible for all development activities, making analytical technology transfer a critical component of ensuring consistency, compliance, and product quality across sites.

Note:

• The Lab that sends the method is called the sending lab.
• The Lab that receives the method is called the Receiving lab.

Why is Analytical Method Transfer (AMT) Important?

• Ensures consistency, reliability, and compliance across different sites.
• Supports scale-up and commercial manufacturing.
• Complies with regulatory expectations (e.g., FDA, EMA, ICH Q14, Q2(R2)).
• Minimises variability and method-related product failures.

Type of Analytical method tech transfer

Tech transfer may be performed between:

• Analytical Lab to QC lab (within the organisation)
• Analytical Lab to QC Lab (of different organisations)
• QC lab to QC (a different QC lab of the same organisation)
• QC lab to QC lab of different organisations

Methods which need tech transfer

1. Assay Methods – to determine the active pharmaceutical ingredient (API) content.
2. Impurity Methods – to detect and quantify degradation products or impurities.
3. Dissolution Testing – for drug release profiles.
4. Content test
5. Chiral purity test
6. Organic volatile impurities (OVI)
7. Microbiological Methods

Note:

• More tests can be considered based on the criticality of the test
• Sometimes, Analytical technology transfer is also performed on critical identification tests like FTIR

Stages of Technology Transfer

Common Analytical Method Transfer Models

1. Comparative Testing – both labs analyse the same sample.
2. Co-validation – both labs validate the method simultaneously.
3. Revalidation at Receiving Site – full or partial validation repeated.
4. Transfer Waiver – applied when the same equipment/methods/personnel are used.

Challenges in Analytical Method Transfer

• Instrument or method variability (e.g., HPLC column type, detectors).
• Incomplete documentation or lack of method robustness.
• Operator skill level differences.
• Environmental factors (temperature, humidity, etc.).

Best Practices

• Ensure method robustness before transfer (ideally via method lifecycle management).
• Use ICH Q14 and Q2(R2) guidelines for method development and validation.
• Maintain clear, traceable, and well-documented communication between sites.
• Conduct risk assessments and apply Quality by Design (QbD) principles.

Regulatory Guidance

• ICH Q14: Analytical Procedure Development
• ICH Q2(R2): Validation of Analytical Procedures
• FDA Guidance: Analytical Procedures and Methods Validation for Drugs and Biologics
• WHO Technical Report Series No. 961, Annex 7

Conclusion

Analytical method transfer is a critical step in the pharmaceutical lifecycle, ensuring that validated analytical procedures are reliably reproduced across different laboratories and manufacturing sites. It plays a vital role in maintaining product quality, regulatory compliance, and patient safety. A successful transfer requires thorough planning, robust documentation, effective communication between sending and receiving units, and adherence to global regulatory guidelines such as ICH Q14 and Q2(R2). By addressing potential gaps through training, method verification, and data evaluation, companies can minimise risk and ensure a seamless transition from development to commercial production.

Related

1. Relative Response Factor (RRF) in Pharmaceutical Analysis
2. What Is Analytical Method Validation In Pharmaceutical Analysis
3. Precision In Method Validation: How to Get Mastery In 5 Minutes

FAQs

When is the analytical method transfer required?

It is typically required:

• Before commercial manufacturing begins.
• When production or testing is moved to a new site.
• During scale-up activities.
• After outsourcing testing to third-party labs (CROs/CMOs).

What is the difference between method validation and method transfer?

• Method Validation proves that a method is suitable for its intended purpose (accuracy, precision, specificity, etc.).
• Method Transfer ensures that the validated method can be accurately and consistently reproduced at a different site.

What are the common causes of failure during analytical method transfer?

Answer:
Common causes include:

• Differences in instrumentation or software
• Variations in reagents or standards
• Inadequate analyst training
• Poor method robustness
• Environmental differences (e.g., humidity, temperature)

Further Reading

• ICH Q14: Analytical Procedure Development
• FDA Guidance: Analytical Procedures and Methods Validation for Drugs and Biologics
• Handbook of ANALYTICAL VALIDATION: Michael E. Swartz Ira S. Krull