Group 6: Validation based on USP, EP (Ketua: Fasiha)
United State Pharmacopeia
(USP)
Methode validation as a process by which it is established through laboratory studies that the performance characteristics of a method meet the requirements for its intended analytical applications.
European Patent Validation (EP)
the process of converting a single granted European Patent Application into a national patent in one or more of the 42 European Patent Organisation member, extension and validation states.
Method Validation
Accuracy
Validation Process
Stage 2 : Grant
(from Desicion to Grant to Grant Date)
The closenes of test result obtained from an analytical method to the true value. It must be determined across its range of applications
Precision
The degree of agreement among individual test results when the method us applied repeatedly to multiple sampling of a homogeneous sample
Factors Regulation Requirements
Specificity
The ability of a method to assess unequivocally, the analyte in the presence of components expected to be present such as impurities, degradation products, other ingredients and other possible matrix interference.
Stage 1 : Acceptance of Text
(from receipt of Intention to Grant to Desicion to Grant
Detection limit
Quantitation Limit
A characteristics applied to limit test , and refer to the lowest amount of analyte in a sample that can be detected, but not necessarily quantitated
Characteristics of quantitative assays for low levels of compounds in sample matrices. It is the lowest amount of analyte in a sample that can be determined by the method with acceptable precision and accuracy.
Stage 3 : Validation
(from Grant Date to Validation completion)
Changing regulations in respect of the original application date
click to edit
The language of proceedings
Linearity
Certain parts of the patent have references to other sectioj
The ability of method to generate results that are directly proportional to the concentration of analyte in sample across the method's range of applications
Range
An analytical method is defined as the interval between the upper and lower level of analyte that yield suitable precision, accuracy and linearity.
38 EP Organisation Member participate in the validation
Robustness
A measure of a method's capacity to remain unaffected by small but deliberate variations in procedural parameters.
Validation Dateline
(3 months deadline from the European Grant Date)
If extension to this deadline, involve additional fees
Official Language EPO
- English
- France
- Germab
Benefits After Improvement of EP
Reduced cost
Dramatic time saving
Reduced risk
Independence
Must USP Method be validate?
There is no general requirement that USP Method be validate, since there were successfully validate prior to their inclusion within the USP.
The suitability of USP Method be determined under conditions for the specific sample to be tested and by the laboratory doing the testing
USP Method and Compendial method in general must be varified.