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Group 3: Validation based on ASTM and AOAC (Ketua: Baim) (AOAC (develop…
Group 3: Validation based on ASTM and AOAC (Ketua: Baim)
AOAC
Association of Official Analytical Chemist
also known as AOAC International .
volunteer base
independent, third party, non profit association
develop analytical method :
food and beverage
dietary supplement
infant formula
pharmaceutical
fertilizer
Purpose of validating
1.Determine the value, necessity,characteristics of ingredients present.
2.Product meets specifications.
3.Product meets regulatory requirements.
4.Determine the present and amount of a component,contaminant or the nutrient.
5.Identity a product and/or its components
Single Laboratory Validation Work
1.Preparation of the laboratory sample
2.Identification
3.Method of analysis or protocol
4.Optimization
5.Reference standard
6.Ruggedness trial
7.Specific variables
8.Analysis addition
9.Reextraction of the extracted residue
10.Comparison with different solvent
11.Comparison with result from a different procedure
12.System suitability checks
A = Iron and Steel Materials
B = Nonferrous Metal Materials
C = Ceramic, Concrete, and Masonry Materials
D = Miscellaneous Materials
E = Miscellaneous Subjects
F = Materials for Specific Applications
G = Corrosion, Deterioration, and Degradation of Materials
ASTM
is globally recognized for developing and publishing technical standards and test protocols.
ASTM E2500
Specification, Design, and Verification of Pharmaceutical and Bio-pharmaceutical Manufacturing Systems and Equipment
elevates risk-based validation based on managing risk in a structured approach
three elements
1) the risk must be formally identified and quantified
2) effective control measures can be implemented to reduce the risk to an acceptable level
3) validation can be performed to a level that is commensurate to the risk.
1) the risk must be formally
identified and quantified
3) validation can be performed to a level
that is commensurate to the risk.
4). mechanical and/or automated
controls should be rolled out
2) effective control measures can be implemented to reduce the risk to an acceptable level
ASTM E1172
Standard Practice for Describing and Specifying a Wavelength Dispersive X-Ray Spectrometer
Stands for American Society for Testing and Materials
ASTM
https://www.google.com/url?sa=t&source=web&rct=j&url=https://nemc.us/docs/2015/presentations/Tue-Collaborative%2520Efforts%2520to%2520Improve%2520Environmental%2520Monitoring-8.5-Lipps.pdf&ved=2ahUKEwjRwPTG74HmAhXLxjgGHdzTBzMQFjAKegQIAhAB&usg=AOvVaw3DFqn58lwM7qVbJc-prmsQ
ASTM D19
ASTM D8282
Standard Practice for Laboratory Test Method Validation and Method Development