Chemistry Reference
In-Depth Information
tAble 1.4
Information typically Included in a method validation package
section
comments
Tabular list of all samples to be
submitted
List should include lot number, identity, package type and size, date
of manufacture, and quantity.
Analytical Procedures
A detailed description of each of the analytical procedures listed in
the specifications should be submitted.
Validation Data
Appropriate validation data to support the analytical procedures
should be submitted, along with individual values and summary
tables. Representative instrument output, raw data, and information
from stress studies should also be included.
Results
The results obtained for the submitted samples and the dates of the
analysis should be provided. Alternatively, a certificate of analysis
could also be submitted.
Composition
The components and composition of the drug product should be
provided.
Specifications
The specifications for the drug substance and the drug product
should be included.
Material Safety Data Sheets
(MSDSs)
Material safety data sheets (MSDSs) for all samples, standards, and
reagents, as well as any other materials used in the analytical
procedures listed in the method validation package, should be
included.
1.6 vAlIdAtIon process
AMV is a critical part of the overall process of validation in any regulated environ-
ment. AMV is a part of the validation process that establishes, through laboratory
studies, that the performance characteristics of the method meet the requirements
for the intended analytical application and provides an assurance of reliability dur-
ing normal use, sometimes referred to as “the process of providing documented
evidence that the method does what it is intended to do.” Regulated laboratories
must perform AMV in order to be in compliance with government or other regula-
tors, in addition to being good science. A well-defined and documented validation
process can not only provide evidence that the system and method are suitable for
the intended use, but also aid in transferring the method and satisfy regulatory com-
pliance requirements.
Validation is also the foundation of quality in the laboratory, and AMV is just
one part of a regulatory quality system that incorporates both quality control and
quality assurance [12,14]. The terms
quality control
and
quality assurance
often
are used interchangeably, but in a properly designed and managed quality system,
the two terms have separate and distinct meanings and functions. Quality assurance
(QA) can be thought of as related to
process
quality, whereas quality control (QC) is
related to the quality of the
product
. In a given organization, it does not matter what
the functions are named, but the responsibilities for these two activities should be
clearly defined. Both quality assurance and quality control make up the Quality Unit
