Overview:
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
These methods include analytical procedures that test for identity,
purity, potency, and stability of drug substances and drug products.
Clinical laboratories also must follow stricter procedures for
accreditation and validation of test methods per current ISO
requirements.
Selecting the right method to validate or if a method is ready for
validation starts with the research lab or method development lab and
data that support the decision to proceed. Tight timelines or inadequate
method development data can lead to premature advancing of a method to
validation.
Rushing into validation can lead to failed validation runs involving repeating assay runs.
Excessive repeat rate during validation does not support the level of
confidence expected for validated methods. Understanding the
requirements for a method to be considered validated helps with the
decision-making process to move from development to validation.
Using Design of Experiments (DOE) can help collect a larger dataset
using fewer assay runs to support the decision to move from development
to validation. More data points can support statistical analysis used to
set acceptance criteria for the method during validation.
Data from DOE can also help analysts understand the limits of the assay
and which robustness parameters to confirm during validation. Also,
having a thorough understanding of regulatory agency expectations can
prevent unnecessary problems with setting the acceptance criteria for
bioanalytical methods.
This 3-hour webinar will describe essential practices for bringing
analytical methods from development through validation in laboratories
supporting biologic products as well as qualification or validation of
methods used in clinical laboratories.
The methods that are selected for each test condition must be developed
with validation in mind. These methods should be rugged selective, and
specific.
Validated methods are also necessary to establish stability of large
molecules. The ability to detect differences in responses between the
stable drug and partially degraded drug should be significant in the
validated method.
Any change that has a significant impact on potency or identity of the
drug should be detected by stability-indicating validated methods.
Data analysis, data reporting, and training of analysts are key components in the method validation process.
Why you should Attend:
Method validation guidance has become increasingly more consistent.
Regulatory agency documents now offer firm guidance on expectations on
assay method performance to meet the status as validated for intended
purpose.
Specific criteria for system suitability and acceptance criteria for
validation parameters has evolved with input from Sponsors and
laboratories performing testing. Yet, with the availability of solid
guidance documents, some laboratory personnel may still struggle with
completing validation of bioanalytical methods. A main concern is
ruggedness of the method during active long-term use for analysis of
analytes in matrix.
Adopting solid principals for development and optimization of the method
should result in an assay that is expected to meet ruggedness,
precision, accuracy, selectivity, sensitivity, dilutional linearity, and
specificity.
Although there is typically no set number of assay runs to complete
development and optimization, collecting the most data with the minimum
number of plates should be considered. However, the number of plates run
should be sufficient to assess ruggedness prior to the formal
validation.
The validation should be designed to accomplish the purpose in a minimum
number of runs. When proper development is not performed and the
decision to move into validation does not have enough supporting data,
assay failure during validation can result.
Failures of runs during validation can lead to interruption of the
validation with subsequent additional method development required prior
to entering validation again.
This is not just time-consuming with an impact on timelines but uses
reagents, that may be critical, without producing usable data.
This webinar is designed to walk attendees through steps to consider
during method development that support the decision to proceed to
validation.
Validation parameters will also be discussed following the recently published Bioanalytical Method Validation guidance.
Areas Covered in the Session:
- Understanding "validation"
- Defining what procedures are required for the drug or biologic testing
- Developing new test methods
- Selecting the reference material/standard
- Confirmation testing of the reference material/standard
- Qualifying reagents - determining critical reagents
- Defining the validation procedure - the protocol
- Writing the methods to be validated
- Using compendial methods
- Acceptance criteria and statistical methods
- Setting ranges and specifications post validation
- Training and documentation
- Life cycle management - revalidation (changes in methods)
Who Will Benefit:
- Validation scientists in bioanalytical or clinical laboratories
- Development scientists in bioanalytical or clinical laboratories
- QA Documentation Specialists
- Regulatory Specialists
- Consultants
- Directors of Outsourcing
- Method trainers
- Statistical staff