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Analytical Method Mini-Validation or Method Verification: Quality Need
Table of Contents
- Introduction and outcome
- Analytical method mini-validation
- Need for Analytical method mini-validation study
- Methods for which Analytical method mini-validation is performed
- Strategy for Analytical Method Mini Validation
- Difference between Analytical Method Validation and Analytical Method mini validation
- Advantages of the Analytical method of mini-validation
- Conclusion
Introduction and outcome; Analytical Method Mini-Validation or Method Verification
It is impossible for any Pharmaceutical company to perform the Analytical method validation of all the methods due to various reasons like timeline, cost and resources. That is why companies also do the Analytical Method mini-validation in some cases. Since there are no guidelines on the Analytical method mini-validation and hence there is a lot of confusion among Pharma professionals related to the Analytical method mini-validation . Several Pharma professionals requested me to share skill-based knowledge on it, so I decided to write a blog on it.
In this blog, I will share my skill-based knowledge for a better understanding of this topic. This Post will enable you to answer many questions related to this topic.
Analytical method mini-validation or Method Verification
Analytical method mini-validation or method verification is performed to check the suitability and validity of an Analytical method for its intended use. This test confirms that the method will pass the Analytical Method validation test if performed.
The analytical method mini-validation study is also called the Analytical method verification study.
Need for Analytical method mini-validation or Method Verification
This study is performed to check the suitability and validity of an Analytical method for its intended use. This test confirms that the method will pass the Analytical Method validation test if performed.
Procedure for performing Analytical method mini-validation or Method Verification
In the Analytical method, mini-validation selected parameters of the Analytical validation are carried out in a surgical manner. Based on the sensitivity of the method project coordinator decides the Analytical method validation parameters.
Methods for which Analytical method mini-validation or Method Verification is performed
Analytical method mini-validation is performed in the following cases:
- For newly developed methods
- For those methods which are used only to answer regulatory queries such as carry-over tests, content test
- Validated customer’s method
- Methods which are validated in the commercial laboratory &
- Pharmacopeial method
For newly developed methods
Once any Analytical method is developed then mini validation is performed and a report is prepared. In this case, it is part of the development report.
Later on, complete Analytical method validation may be performed based on requirements.
For those methods which are used only to answer regulatory queries
When the method is developed to answer only regulatory queries, customer queries and Deficiency letter queries to see the trend data and only limited use (not for routine use); In that case mini-validation is performed.
In that case, there is no need for complete Analytical method mini-validation.
When any method is taken from the outside (e.g. customer) for analysis and release of the sample in that case Analytical method mini-validation is performed.
Methods which are validated in the commercial laboratory
If any method has been validated in the commercial laboratory, in that case, Analytical mini-validation is performed before batch analysis and release.
Pharmacopeial method
Sometimes the sample is analysed and released by the Pharmacopeial method. An analytical method mini-validation is performed for such methods to check the suitability of the method for the required analysis.
In the Pharmacopeial method generally, specificity, DL, QL precision and recovery are performed.
Mini-validation is performed for both published and draft Pharmacopoeia methods.
Note: Based on the sensitivity of the method Analytical validation parameters may be modified
Responsibility
Generally, the Analytical department is responsible for Analytical method mini-validation. The project coordinator decides the Analytical parameters for Analytical method mini-validation.
Strategy for Analytical Method Mini Validation or Method Verification
- Find out the criticality of the method
- Decide the Analytical parameters
- Start and complete the mini-validation
- Prepare the report and get it approved as per the organisation’s policy
Note: In Analytical method mini-validation there is no need to prepare the protocol
Difference between Analytical Method Validation and Analytical Method Verification
Following are the differences between Analytical Method Validation (AMV) and Analytical Method Mini Validation (AMMV)👇:
| Parameters | AMV | AMMV |
| Precision | Yes | Can be done surgically |
| Accuracy & Recovery | Yes | Can be omitted or can be done in a surgical manner |
| Detection limit | Yes | Yes |
| Quantitation limit | Yes | Yes |
| Specificity | Yes | Yes |
| Linearity | Yes | Can be done in a surgical manner |
| Range | Yes | Can be done in a surgical manner |
| Stability of solution | Yes | Can be omitted or can be done in a surgical manner |
| Robustness | Yes | Can be omitted or can be done in a surgical manner |
| Conclusion | Yes | Yes |
Advantages of the Analytical method of mini-validation
The following are the advantages of Analytical method mini-validation:min-validation:
- It indicates the suitability of the method for the intended use
- It requires less time, resources and cost
- Accepted by regulators for some of the methods
Case study -1:
Selection of Mini-validation parameters for separation of Benzene, Naphthalene and Anthracene:
Case study -2:
Selection of Mini-validation parameters for separation of Ortho Cresol, Meta Cresol and Para Cresol:
Image source (Case stdy-1 and 2): phramaknowledgeforum
Conclusion
This is all related to the Analytical Method mini-validation. Now I can assume that this post must have cleared all your doubts related to this topic. You will also agree with me that Analytical mini-validation should be done keeping in mind the end result i.e. method’s capability to pass the validation study.
Please write your review in the comment section. It will motivate me to bring more such skill-based posts for you😼.
FAQs
What is the Analytical method of mini-validation or Method Verification?
Analytical method validation confirms suitability of any method for its intended use.
Why method verification is performed?
Analytical method mini-validation is performed to avoid any failure during complete validation.
How it is performed?
In the Analytical method mini-validation few parameters like specificity, DL, QL, precision are performed. Validation parameters are selected based on criticality of the method
In which case Analytical method method verification/mini-validation is performed?
Analytical method mini-validation can be performed for newly developed methods, for pharmacopeial methods and for customer’s method
Who will be responsible for method verification/analytical method mini-validation?
analytical Project coordinator is responsible for Analytical method validation
What is the difference between Analytical method validation and Method Verification
The major difference is in Analytical validation all parameters are performed whereas in analytical method min-validation only few parameters are performed.
What are the advantages of the Method Verification/Analytical method mini-validation?
It indicates the suitability of the method for the intended use. It is also accepted by regulatory agencies.
What should be the strategy to perform Method Verification or Analytical method mini-validation?
First, find out the criticality of the method. Based on criticality select validation parameters, perform the validation and make the report.
Abbreviations
- AMMV: Analytical method mini-validation
- QL: Quantitation limit
- DL: Detection limit
Clean, Clear and Concise Synopsis
Thanks for your comments. Keep reading.
Very apt very useful concise and in very simple easy to understand words
Very precise and good information you captured here Dr. I appreciate your efforts and sharing attitude to educate others.
Given blog is very useful to understand the basic concepts of method validation and method verification. Required more for regulatory approch with document authentication.
Thanks for your valuable feedback. Keep reading and sharing
Thanks you. Keep reading and applying in routine activity
A sea of knowledge in very comprehensive and easy to learn. The content is very useful for pharma, QC , regulatory and audit professionals.
A sea of knowledge in a very comprehensive and easy to learn.
Very useful to pharma QC, regulatory, Analytical and audit professionals.