K-Patents PR-23 for K-Patents - Manual (Page 54)

Document/Revision No. IM-GB-PR23-ACP: Rev. 1.0 Effective: December 15, 2011
54
Appendix to the Instructions Manual PR-23
9.2 Protocol objectives
Method validation is the process by which it is established that performance characteristics
of the method meet the requirements for the intended analytical applications.
The protocol objectives for analytical method validation are:
● Product knowledge, establishing Critical Quality Attributes (CQA) and parameters for
the manufacturing process.
● Protocol acceptance values: Establishing proven acceptable ranges.
● Product validation protocols carried out in compliance with the relevant authority’s
regulations and procedures.
To obtain the relevant knowledge of Refractive Index behavior, multiple readings should
be taken and recorded with the different variables applied. Compilation of the obtained
knowledge requires a rigorous recording and documentation protocol to be first established.
These documenting procedures must be carried out in compliance with all the relevant
authorities’ documentation requirements.
Testing samples from progressive stages of a process is essential in designing a valid
refractive index monitoring regime.
The Static sampling LTC is used to establish the refractive index of the product solutions
at various temperature settings through adjustment of the Thermostatic Bath feed to the
heating/cooling jacket. The test samples should be in accordance with process values.
Insertion into the LTC and testing follow the same procedures given in
Section 4 Refractive
index n
D
verification of Laboratory Test Cuvette.
Thorough cleaning of all wetted surfaces is required between each sample test as
described in the relevant section. Once a valid set of Refractive index parameters has been
established using the static LTC, the Continuous sampling LTC can be used to monitor and
verify laboratory pilot production batches.