Answers to Questions about Analytical Method Validation, Verification, and Transfer

Introduction

Analytical method validation, verification, and transfer are critical aspects of quality control in the pharmaceutical industry. These processes ensure that the analytical methods used for drug testing are reliable, accurate, and consistent. This article aims to answer some of the most frequently asked questions about these processes, providing valuable insights for anyone involved in analytical development or working with an analytical development company.

What is Analytical Method Validation?

Analytical method validation is the process of confirming that an analytical procedure is suitable for its intended purpose. It involves a series of tests to establish the method’s accuracy, precision, specificity, and other essential characteristics. With CDMO services, the objective is to provide high assurance that the method will consistently produce results that meet predetermined specifications and quality attributes.

Why is Analytical Method Validation Necessary?

Method validation is essential for several reasons:

• Good Science:

  It establishes the fitness-for-purpose of the method.

• Regulatory Requirement:

  Analytical data are crucial for regulatory submissions, and regulatory bodies require proof of the safety and quality of products.

• Good Manufacturing Practice (GMP):

  It is an integral part of GMP, ensuring that the products meet quality and safety standards.

What is Analytical Method Verification?

Method verification is the provision of objective evidence that a given analytical method fulfills specified requirements. It is usually less extensive than validation and is often performed when a well-established method is adapted or when minor changes are made to the method parameters.

What is Analytical Method Transfer?

Method transfer is the documented process that qualifies a laboratory to use an analytical test procedure that originated in another laboratory. This ensures that the receiving lab has the procedural knowledge and ability to perform the transferred analytical procedure as intended.

When Should These Processes Be Performed?

• Analytical method validation:

  This should be performed before the method is used for ongoing or routine testing, and when the method is part of a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) submission

• Verification:

  This should be done when there are changes in the process for the synthesis of the drug substance or the composition of the finished product.

• Transfer:

  Should be conducted when there is a change in the laboratory performing the method.

What Characteristics Should Be Considered During Validation?

During validation, the following characteristics should be considered:

• 1)Specificity
• 2)Linearity
• 3)Range
• 4)Accuracy
• 5)Precision
• 6)Detection limit
• 7)Quantitation limit
• 8)Robustnesslimit

Who Should Perform These Processes?

Skilled and qualified analysts who are trained in Good Laboratory Practices (GLP) should perform these processes. Ideally, validation should be conducted in the end-user (QC) laboratory where the method will be regularly employed.