Phasing validation

P8.1 The molar enthalpy of vaporization of liquid mercury is 59.229 kJ-mol l at its normal boiling point of 630.0 K. The heat capacities of the liquid and gaseous phases, valid over the temperature range from 250 to 630 K, are as follows ... 

The model was also extended11 to single-crystal surfaces of silver. Although the calculated inner-layer capacitances varied in the right way from one face to another, the values were much too low. The problem was suspected to be due to the importance of the d electrons. What is still needed in this model is a better treatment of the solvent phase, valid at higher charge density, and a better way of deriving the repulsive potential of the solvent on the electrons, perhaps by a direct pseudopotential calculation, as done by Price and Halley.98,99... 

A validated manufacturing process is one which has been proved to do what it purports or is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment, systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. 

FIP (1980) Federation International Pharma-ceutique, Commission of Official Control Laboratories and Industrial Pharmacists, Conference 1980 Guidelines for Good Validation Practices [4] Definition, development phase, production phase, validation of existing processes, revalidation, responsibilities... 

The validation report should contain reference to the analytical methods (specific code number used as identifier within the pharmaceutical organization) and the corresponding drug substance or product name. Note that for early-phase method validation reports the results maybe filled in a predefined table and compared against the acceptance criteria. However, for late-phase validation, more explicit reports are generated explaining each and every experiment, with detailed steps of sample and standard preparation. 

Specification limit. Note that the reporting level can never be lower than the limit of quantitation (LOQ) of the method. However, during early-phase validation for drug products, if authentic degradation products are not available, then low amounts of API are added (LOQ to 120% specification limit of largest impurity) to the placebo and the recovery experiment is performed. 

Kojima H, Hayashi K, Sakaguchi H, Omori T, Otoizumi T, Sozu T, Kuwahara H, Hayashi T, Sakaguchi M, Toyoda A, Goto H, Watanabe S, Ahiko K, Nakamura T, Morimoto T (2013) Second-phase validation study of short time exposure test for assessment of eye irritation potency of chemicals. Toxicol In Vitro 27 1855-1869... 

Hardalupas, Y. and Taylor, A.M.K.P., Phase validation criteria of size measurements for the phase Doppler technique. Exper. in Fluids, 17, 253-258 (1994)... 

During the development phase, validated procedures may not always be available, which makes it difficult to know in advance the critical parameters and the in-process controls that would help to control these parameters. In these cases, provisional production parameters and in-process controls may usually be deduced from experience with analogues. Careful consideration by key personnel is called for in order to formulate the necessary instructions and to adapt them continually to the experience gained in production. 

Project concept phase Validation planning phase... 

User Requirements Specification (URS) phase Validation planning phase Supplier audit phase... 

System Software POL Interpreter Error - White Box tests and Black Box tests in Developing Phase - Validation... 

Scheme 5.3. Solution-phase validation of designed template and X-ray crystal structure of compound 18.

At high pressures, where the virlal equation is no longer useful, empirical equations must be used to calculate fugacity coefficients. However, contrary to Method (a), the equation of state now need not hold for both the vapor phase and the liquid phase validity in the vapor phase is sufficient. 

A. Method Development Life Cycle and Phasing Validation... 

---