Overview:
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
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