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Good practice

GMP touches on all facets of drug manufacture. Personnel must be properly qualified for their tasks. The building should be adequately equipped in terms of utilities, air quality, and sanitation. All manufacturing machinery and equipment must be properly and regularly maintained, cleaned, and calibrated. Materials used in the manufacture of an active pharmaceutical ingredient (API) should be monitored for quality. Many additional aspects of drug manufacture are addressed by GMP. Implementation of GMP is the problem of the manufacturer. GMP does not specify how different aspects of manufacture should be handled. GMP states only that the aspects must be addressed systematically. [Pg.349]

GMP requires a massive amount of recordkeeping. Records prove that GMP guidelines are being followed. Although the burden of documenting all facets of manufacturing may seem excessive, records help ensure the quality of an API and safety of both employees and patients. Records also help to track down problems if an issue arises. [Pg.349]

The final marketed form of a drug is called a drug product. A drug product includes not only the drug itself but also various components called excipients. Examples of excipients [Pg.349]

TABLE 13.7 Allowable limits of metals in orally delivered drugs38 [Pg.350]


Certain key stages in the EIA process have been adopted by many countries. These broad stages reflect what is considered to be good practice within environmental assessment and include ... [Pg.72]

If formation wafer production is expected, a chemical analysis of the water will also be required. It is good practice to record the details of the methods used for sampling and analysis in each case so that measurement uncertainties can be assessed. [Pg.237]

It is good practice to reviewa project on completion and record the reasons for departure between planned and actual performance. Where lessons can be learned, or opportunities exploited, they should be incorporated into project management guidelines. Some companies hold post project sessions with their contractors to explore better ways of handling particular issues, especially when there is an expectation of additional shared activities. [Pg.294]

To protect both parties in a contract arrangement it is good practice to make a contract in which the scope of work, completion time and method of reimbursement are agreed. Contracts are normally awarded though a competitive tendering process or after negotiation if there is only one suitable contractor. [Pg.301]

Resias are seldom used oace and discarded. Whether the system is mn batchwise or ia columns, the resia must be periodically removed from service and regenerated. An exception is the use of a resia as a catalyst ia organic reactions. Each cycle consists of two principal steps, adsorption and regeneration, and one or more iatermediate steps, tinse and backwash. Eailure to use good practices results ia poor cycHc performance. [Pg.383]

It is good practice to keep concentrations of airborne nickel in any chemical form as low as possible and certainly below the relevant standard. Local exhaust ventilation is the preferred method, particularly for powders, but personal respirator protection may be employed where necessary. In the United States, the Occupational Safety and Health Administration (OSHA) personal exposure limit (PEL) for all forms of nickel except nickel carbonyl is 1 mg/m. The ACGIH TLVs are respectively 1 mg/m for Ni metal, insoluble compounds, and fume and dust from nickel sulfide roasting, and 0.1 mg/m for soluble nickel compounds. The ACGIH is considering whether to lower the TLVs for all forms of nickel to 0.05 mg/m, based on nonmalignant respiratory effects in experimental animals. [Pg.14]

Cyogenics Safety Manual—A Guide to Good Practice, Safety Panel, The British Cryogenics Council, London, 1970. [Pg.483]

Along with other elements of the invention, it is good practice to include within the record of invention any first written descriptions or drawings of... [Pg.31]

Has the Invention Been the Subject of a Prior Foreign Patent Although one cannot be sure when, or even whether, a patent wiU issue from any appHcation, it is good practice to make sure your U.S. patent appHcation is filed within 12 months of the first foreign filed appHcation. The patenting of an invention in another country by the inventor or another party wiU preclude the issuance of a patent on the same invention in the United States. [Pg.32]

Checking Against Optimum Design. This attempts to answer the question whether a balance needs to be as it is. The first thing to compare against is the best current practice. Information is available ia the Hterature (13) for large-volume chemicals such as NH, CH OH, urea, and ethylene. The second step is to look for obvious violations of good practice on iadividual pieces of equipment. Examples of violations are stack temperatures > 150° C process streams > 120° C, cooled by air or water process streams > 65° C, heated by steam t/ urbine 65% reflux ratio > 1.15 times minimum and excess air > 10% on clean fuels. [Pg.94]

Side Effects and Toxicity. Adverse effects to the tricycHc antidepressants, primarily the result of the actions of these compounds on either the autonomic, cardiovascular, or central nervous systems, are summarized in Table 3. The most serious side effects of the tricycHcs concern the cardiovascular system. Arrhythmias, which are dose-dependent and rarely occur at therapeutic plasma levels, can be life-threatening. In order to prevent adverse effects, as weU as to be certain that the patient has taken enough dmg to be effective, the steady-state semm levels of tricycHc antidepressant dmgs are monitored as a matter of good practice. A comprehensive review of stmcture—activity relationships among the tricycHc antidepressants is available (42). [Pg.468]

Alternatively, it is good practice to have a low average collection period, as given by... [Pg.851]

Nonmandatory Appendixes These cover a number of subjects, primarily suggested good practices and other aids in understanding the code and in designing with the code. Several current nonmanda-tory appendixes will probably become mandatoiy. [Pg.1025]

De.sign dry-bulb temperature. The typically selected value is the temperature which is equaled or exceedea 2 /4 percent of the time during the warmest consecutive 4 months. Since air temperatures at industrial sites are frequently higher than those used for these weather-data reports, it is good practice to add 1 to 3°C (2 to 6°F) to the tabulated value. [Pg.1081]

Since it is good practice to maintain a selected inventory of spare parts for drives, economy can be achieved by standardizing conveyor drives throughout the plant. For example, intermediate speed reduction by means of V belts, sheaves or chains, and sprockets can frequently permit using the same speed-reducer size for several drives. Thus, it may be necessary to keep only one repair-stock speed reducer for a number of conveyors. [Pg.1913]

It is good practice to provide 10 to 20 percent more quench hquid than the minimum amount calculated. [Pg.2299]

It is good practice to visually inspect the condition of bonding cables during each use and to measure the resistance of temporary bonding cables, at least annually, to confirm that it is less than, say, 25 H. [Pg.2333]

In the absence of factual corrosion information for a particular set of fluid conditions, a reasonably good selection would be possible from data based on the resistance of materials to a very simifar environment. These data, however, should be used with some reservations. Good practice calls for applying such data for preliminary screening. Materials selected thereby would reqmre further study in the fluid system under consideration. [Pg.2417]

The choice of materials from which to make the holder is important. Materials must be durable enough to ensure satisfactory completion of the test. It is good practice to select very resistant materials for the test assembly. Insulating materials used are plastics, porcelain, Teflon, and glass. A phenohc plastic answers most purposes its principal hmitations are unsuitability for use at temperatures over I50°C (300°F) and lack of adequate resistance to concentrated alkalies. [Pg.2438]

Aside from the fundamentals, the principal compromise to the accuracy of extrapolations and interpolations is the interaction of the model parameters with the database parameters (e.g., tray efficiency and phase eqiiilibria). Compromises in the model development due to the uncertainties in the data base will manifest themselves when the model is used to describe other operating conditions. A model with these interactions may describe the operating conditions upon which it is based but be of little value at operating conditions or equipment constraints different from the foundation. Therefore, it is good practice to test any model predictions against measurements at other operating conditions. [Pg.2578]

Listed below are several good practices aimed at minimizing operator-induced process incidents. [Pg.131]


See other pages where Good practice is mentioned: [Pg.284]    [Pg.329]    [Pg.357]    [Pg.358]    [Pg.6]    [Pg.284]    [Pg.316]    [Pg.573]    [Pg.90]    [Pg.535]    [Pg.128]    [Pg.40]    [Pg.75]    [Pg.304]    [Pg.304]    [Pg.321]    [Pg.282]    [Pg.478]    [Pg.149]    [Pg.150]    [Pg.1099]    [Pg.1106]    [Pg.1126]    [Pg.1852]    [Pg.1928]    [Pg.1953]    [Pg.2210]    [Pg.2307]    [Pg.2339]    [Pg.2494]   
See also in sourсe #XX -- [ Pg.348 , Pg.349 , Pg.350 ]




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