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Report history

A historic summary of the development of the product serves many purposes. The foremost purpose is to apprise the investigators of the scope of inspection. The investigators learn more about the product from the history of its development than from the analysis report of the finished product. This shows the awareness of the firm about the development process. This document should include a description of the API, the formulation, and the analytical methods. These sections should be clearly marked or presented in separate binders. The summary section should highlight how the biobatch is linked to the full-scale batch with respect to validation and scale-up of production. This section also offers an opportunity for the firm to address the issues that it considers critical. [Pg.47]


The practical applications for cryogenic turboexpanders are best illustrated by industry case history reports that follow. [Pg.42]

Equipment history reports should also be available. These reports provide long-term data on the condition of plant equipment and are valuable for analysis. [Pg.808]

Debenham, Frank, British Antarctic CTerra Nova") Expedition, 1910, Natural History Report, Geol. I, 103 (1921). [Pg.173]

Steel phases have an influence on the rate of corrosion. Ferrite has a weak resistance to pitting. The presence of martensite can increase the hydrogen fragilization of steel. Intermetallic phases as Fe2Mo in high Ni content alloys can influence the corrosion resistance. The precipitate CuA12 in aluminum alloys the series 2000 is more noble than the matrix, with corrosion around the precipitate. The majority of case histories reported in the literature have involved austenitic stainless steels, aluminum alloys, and to a lesser degree, some ferritic stainless steels and nickel-based alloys.31... [Pg.376]

Keratoconus is an ectatic corneal dystrophy that tends to be bilateral but may be asymmetric and generally manifests in the second or third decade of life. There is evidence that keratoconus is a hereditary condition, with a family history reported in 6% to 8% of patients with the disease.The prevalence in first-degree relatives is 15% to 67% higher than in the general population, and the incidence has been reported at approximately 1 in 2,000. The inheritance pattern has been variably reported as sporadic, autosomal recessive, and autosomal dominant. Keratoconus is likely a multigenic disease with a complex mode of inheritance, and its manifestation likely involves environmental factors. [Pg.490]

Assess medical and drug history, report if taking phenothiazines, digoxin, calcium channel blockers, or other antihypertensives. [Pg.212]

Assess gastric pH (greater than 5 is desired), blood urea nitrogen (BUN), and creatinine. Assess drug history report probable drug-drug interactions. [Pg.282]

Before administration Assess patient s pain, including the type, duration, severity, frequency, and location. Assess GI complaints. Assess mental status. Assess fluid and electrolyte imbalances, including intake and output. Assess gastric pH (greater than 5 is desired), BUN and creatinine. Assess drug history report probably drug-drug interactions. [Pg.283]

Inorganic Mercury. Ingestion of metallic mercury results in negligible absorption and little effect on the gastrointestinal tract. The two case histories identified are unusual in that the dose levels could be reasonably well quantified. The first case history reported ingestion of 15 mL (204 g) of metallic mercury by a 17-year-old male storekeeper who swallowed mercury from the pendulum of a clock (apparently out of curiosity rather than as a suicide attempt). On admission, and 24 hours later, he was symptom free, and physical examination was normal. The patient complained of no gastrointestinal symptoms, and was treated with a mild laxative and bedrest (Wright et al. 1980). [Pg.129]

Inorganic Mercury. The oral absorption of metallic mercury is negligible, and even massive doses have not resulted in neurological effects. The wo case histories identified are unusual in that the dose levels could be reasonably well quantified. The first case history reported ingestion of 15 mL (204 g) of... [Pg.145]

Central Vein Occlusion Study Group. Baseline and early natural history report. The Central Vein Occlusion Study. Arch Ophthalmol 1993 111 1087-1095. [Pg.320]

Each and every operation dealing with a file, be it a manipulation or evaluation, will automatically be documented and added as audit trail to the file in terms of the data block wTWffl. You have access to this history report by right-clicking on this icon. [Pg.13]

The rule requires that a 5-year accident history report be prepared for the facility. This report should include a description of injuries or fatalities on or off the site during the 5-year period. However, it does not have to include information about near-miss situations. [Pg.102]

History Report British Antarctic (Terra Nova) Expedition, 1910. Geology l(4a) 103-119... [Pg.365]

Schopf JM, I-ong WE (1966) Coal metamorphism and igneous associations in Antarctica. In Gould RF (ed) Coal science, Adv. in Chemistry Sen, No. 55 156-195. Amen Chem. Soc. Seward AC (1914) Antarctic fossil plants. British Antarctic (Terra Nova) Expedition, 1910. Natural History Report, Geology 1(1) 1-149. British Museum of Natural History, London, England... [Pg.369]

The contractor s implementation pi an indicated that SRS partially complies with the Order for this element. The contractor reported that the areas of noncompliance were corrected by changes to DPSOP-40 ,however, the ability to provide required exposure history reports to terminating employees within the 90-days still has not been achieved. This/will remain an open- item until the ability to produce such reports within the required timeframe is achieved., ... [Pg.96]


See other pages where Report history is mentioned: [Pg.15]    [Pg.124]    [Pg.47]    [Pg.2286]    [Pg.412]    [Pg.571]    [Pg.104]    [Pg.780]    [Pg.570]    [Pg.829]    [Pg.639]    [Pg.22]    [Pg.27]    [Pg.371]    [Pg.72]    [Pg.25]   
See also in sourсe #XX -- [ Pg.13 ]




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