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The Best Practices of Analytical Method Transfer
Table of Contents
- Introduction and Outcome
- Analytical Method Transfer
- Sending Lab or Transferring Lab
- Receiving lab
- Purpose of Tech transfer
- Type of Analytical method tech transfer
- Methods which need tech transfer
- Pre-work for Analytical tech transfer
- Role of Analytical method transfer Protocol
- Conclusion
Introduction and Outcome; Analytical Method Transfer
Analytical method transfer is one of the activities to prove the reproducibility of the analytical method as the overall method will be used in the Quality Control laboratory. Developing the Analytical method is a challenging task for an Analytical scientist. After developing the method, the question arises how will reproducibility of the method be achieved? Analytical Method Transfer plays a vital role in pharmaceutical development. In this post, You will learn, the analytical method transfer, purpose, scope, types, responsibilities (of sending and receiving lab), protocol and pre-work with FAQs
Analytical Method Transfer
In Analytical method transfer, the method of analysis is transferred from one laboratory to another laboratory using the approved protocol. It is the joined activities of Quality control and Analytical research/between the sending site and the receiving site.
The sending Lab is the owner of the method and it is responsible for all development activities. The receiving lab uses the method for routine testing and release. Hence Analytical technology transfer is an important activity.
Sending Lab or Transferring Lab
The Lab that sends the method is called the sending lab.
Receiving Lab
The Lab that receives the method is called the Receiving lab.
Method transfer responsibility
Both the sending Lab and receiving lab are responsible for the transfer activities.
Purpose of Tech transfer
The main purpose for tech transfer is to share all skill-based knowledge with the sending lab. It may be:
- Limitations of the method
- The type of solvents or chemicals will be suitable for the method
- Sample preparation procedure
- Stability of solution
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 (different QC lab of the same organisation)
- QC lab to QC lab of different organizations
Methods which need tech transfer
Tech transfer is performed on the following methods:
- Assay
- Impurity profile or related substances
- Residual solvents
- Content test
- Chiral purity or optical purity
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
Pre-work for Analytical tech transfer:
- Evaluate methods and specifications before starting the Analytical tech transfer
- All standards and markers must be qualified
- Prepare the protocol and get approval from concerned departments like ARD, QC, QA or as per organisational policy
Role of Analytical Method Transfer Protocol
The Analytical method transfer protocol is a predefined and approved document to conduct the Analytical method transfer activities. It contains all the details that are necessary for this study. It is designed by the sending laboratory in coordination with the receiving laboratory. The sending laboratory may be the Analytical department or quality control department and the receiving laboratory will be the Quality control department.
Content of Analytical method Analytical Method Transfer Protocol
The following components are included in any Analytical Method Transfer protocol:
- Introduction
- Purpose
- Scope
- Responsibility
- Methodology
- Instrument details
- Reagent and solvent details
- Standards and impurities or impurities marker
- Sample details and their selection procedure
- Analytical method validation parameters
- Precautions
- Conclusion
Introduction
This section contains specification details, standard test procedure/monograph details and methods on which Analytical technology transfer is going to be conducted.
Purpose
This section defines the principle of Analytical method technology transfer between the different laboratories.
Scope
This section specifies sending laboratory and receiving laboratory details.
Responsibilities
This section defines the details of all individuals who are going to be involved in successfully executing the Analytical tech transfer activities e.g. ARD, QC, and QA.
Methodology
This section contains method details on which Analytical tech transfer is going to be performed.
Instruments details
This section contains instrument details which will be used in the Analytical method technology transfer e.g. instrument, detector, column etc
Reagents and solvents details
This section contains details of the reagent and solvents e.g. make, part number and suitability of equivalent grade
Standards and impurities or impurities marker
This section contains all the standards and impurities details that will be used in Analytical technology transfer activities.
Sample details and their selection procedure
- Ideally, Analytical technology transfer should be performed by both sending and receiving laboratories in triplicate analysis using three different lots.
- In case of the non-availability of three lots, this activity can be conducted using two separate lots in which one lot will be analysed four times and the other lot will be analysed in duplicate.
- In case of the non-availability of two lots, this activity will be conducted using one lot in the analysis six times.
Analytical parameters
In Analytical technology transfer, the following validation parameters must be included in the protocol:
- Specificity
- Method precision
- Recovery at the specification level and
- Sample Analysis
Specificity
All specified and unspecified impurities will be injected by both sending sites and receiving sites to prove the specificity of the method.
Method precision
Method precision parameters will be included in the protocol and will be performed by both sending sites and receiving sites.
Recovery at the speciation level
Recovery at the specification level will be included in the protocol and will be performed.
Sample analysis
Note: Analytical method technology transfer parameters can be added and removed depending on the method’s sensitivity.
Precautions
All the criticality of the method will be included in the method to avoid any failure.
Analytical Methods tech transfer checklist
The analytical method tech transfer checklist should contain the following components:
- Approved protocol
- Monograph or standard test procedure with specification
- List of standards
- List of impurities standards
- List of markers/System suitability markers (if applicable)
- List of samples
- Standard COAs with a retest period
- Impurities standard COAs with retest period
- Marker/System suitability COAs with retest period
- Samples COAs with a retest period
- List of instruments required for Analytical method technology transfer
- Instruments calibration records
- Analyst training records
- List of responsible person of sending and receiving lab
Conclusion
Analytical method technology transfer activity requires the involvement of personnel from various departments in both approval and experimental work. Therefore, there must be strong coordination among all the concerned personnel.This document is necessarily asked by Regulatory agencies in almost all audits and hence guidelines, protocols and organisation policy should be kept in mind while performing this study.
Analytical tech transfer is a vital activity for any organisation and hence strategic planning along with synergistic coordination can lead high level of successful technology transfer. This is all about this article. Write your opinion/question related to this post.
FAQs
What is Analytical method transfer?
The transfer of the method of analysis from one laboratory to another laboratory using the approved protocol is called analytical method transfer
What is the sending lab and its role?
The sending Lab is the owner of the method and it is responsible for all development activities. An analytical method is transferred from the sending lab to the receiving lab. The sending lab may be quality control or analytical research.
What is the receiving lab and its role?
The laboratory in which the analytical method is transferred is called the receiving lab.
Who is responsible for tech transfer activity?
Both the sending Lab and receiving lab are responsible for the transfer activities.
Why tech transfer is performed?
An analytical tech transfer is performed to prove the reproducibility of the analytical method
What are the different types of Analytical tech transfer?
Analytical tech transfer may be performed between Analytical Lab to QC lab (within the organisation) or Analytical Lab to QC Lab (of different organisations) or QC lab to QC (different QC lab of the same organisation) or QC lab to QC lab of different organizations
On which methods tech transfer is performed?
Tech transfer is performed Assay, Impurity profile or related substances, Residual solvents, Content test and Chiral purity method
What is the difference between analytical method validation and analytical method transfer?
In analytical method validation, all validation parameters are performed to see the suitability of the method for intended use whereas in analytical method transfer selected parameters like reproducibility, specificity, and quantitation limit are performed.
What is analytical method transfer waiver justification?
If the pharmacopeial method is used for analysis and release then there is no need for analytical method transfer
Precise and crisp information sir.