Products deviation

When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented. 

List of decomposition products contains 300 substances Predicted reaction products deviate from the experimental... 

Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products... 

The nature of plants having secondary metabolites as defensive agents greatly increases the expectation that there will be interactions with other botanical products and drugs. If well-established traditional botanical products are used according to directions, they are likely a low risk. Risk increases when botanical products are combined with conventional drug therapies and lies in the possibility of unknown natural product-drug interactions. Other risks include product deviation due to misidentification of species, the lack of standardization, or adulteration. Most of the interactions have been reported with cytochrome P-450 (CYP) 3A4, but there are interactions with other metabolism enzymes and transport proteins. 

Document management Change control N onconformances Corrective and preventative actions Biological product deviation Product disposition Validation Production Manufacturing Process monitoring... 

Although the substance of the composition H2S207 is capable of definite existence, the commercial products deviate from the composition expressed by the formula and contain variable quantities of sulphuric acid with pyrosulphurie acid or of pyrosulphuric acid with sulphur trioxide. For the purpose of including all varieties of impure pyrosulphurie acid, the somewhat vague terms oleum, fuming sulphuric acid and Nordhausen sulphuric acid are advantageous. 

The bacterial population faced with the "autumn-input" was derived from an anoxic population (fermentative bacteria, sulfate reducers) which prevailed during summer stagnation. Within this population the input of freshly produced organic material caused a drastic shift. Bacteria primarily reacted with a strong increase in cell volume (biomass production). Deviating from its "normal" distribution (cf. above), the size spectrum was dominated by medium and large-size cells. Following the final breakdown and sedimentation of the autumn phytoplankton bloom, the bacteria subsequently responded with cell division (increase in cell number). 

On some occasions an exception from this case can be observed by so-called nonlinear effects in asymmetric synthesis, in which the relation between the enantiomeric excess of the chiral catalyst or initiator and that of the product deviates from linearity (see Sect. 3.3)... 

Chapter 17 deals briefly with the engineering process control, which primarily involves measurement of a product property and comparison to a desired value. The process operation can be thus immediately adjusted to reduce deviation from the specifications. This feedback procedure can be used to adjust the process whenever the product deviates from the set point and can be used to change operating points and to reject the effect of outside disturbances. 

Reduction of product deviations from attempts to use finished product heels. 

Other factors, such as the leaving ligand, X, can strongly influence the mechanism and the outcome, making the products deviate further from statistical probability. Data on several reactions for [Co(en)2(H20)X]" are shown in Table 12-10. For... 

A discussion on spraying is incomplete without a discourse on nozzle maintenance and testing. In any coating application, the spray nozzle is the single most critical component. Its performance dictates droplet size control, the quality of the applied film and the reproducibility of the resultant product properties. These include appearance, potency, film coating efficiency, and release characteristics. In retrospective process troubleshooting, spray nozzle performance is often the leading cause of product deviations. 

The law of value dominates price movements with reductions or itKieases in required labour time making prices of production fall or rise. It is in this sense that Ricardo (who doubtlessly realized that his prices production deviated from the value of commodities) says that "the inquiry to which I wish to draw the readeKs attention relates to the effect of the variations in the relative value commodities, and not in their absolute value". ... 

Elimination of product deviations generated from attempts to use product heels... 

Introduction Decomposition of oxides with the release of atomic oxygen was apparently the first revealed case where the composition of primary decomposition products deviated from the equilibrium composition. More than 40 years ago, using the colour changes during the reaction of M0O3 with atomic... 

Taguchi defined quality in a negative way. According to him, it is not enough that a product is within the specification limits. The moment a product deviates from the target, it incurs a loss that can be expressed in monetary terms. More the... 

The attributes with the highest regression coefficients in the PLS model would be the priorities for product reformulation. Considering consumers description of Sample A and the ideal product (Table 11.3), and taking into account the percentage of consumers who considered that the product deviated from the ideal, the priority for... 

The overall pyrolysis for both 1-butene and cis-2-butene was found to be first-order. In spite of that, the formation of some individual products deviated significantly from first order. 

Traditionally in manufacturing the concept of quality was conformance to certain dimensions and specifications, the clichd being fitness for purpose . Quality control was achieved by inspection and supervision. Inspection is the most basic approach to quality. The aim being for an inspector to detect, and if sufficiently serious to reject before despatch if a product deviates from a set standard. Inspection will at least provide the customer with an acceptable product. Quality inspection is an expensive method of achieving a basic level of quality. It requires the employment of people to check on the operators. Inspection and supervision does not add value to a product, but does add to the cost ... 

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