Manufacture / manufacturer information supply

The information supplied to the manufacturer should be as detailed as possible and cover the following factors ... 

The concept of the Polymat database was based on the following criteria (1) the data-base is neutral, independent of raw-material manufacturers (2) anyone can use the database (3) all the products on. the European market should, if possible, be included (4) since testing is carried out in accordance with a variety of different international standards, the relevant standard, as well as the testing conditions, is registered (5) during the search, all properties should be capable of being linked with one another as desired and (6) the sources used for the database are the technical data sheets and additional information supplied by raw-material manufacturers, and various lectures, publications, and measured data from different institutes. 

Whether electrostatic technology is superior to magnetic device technology is debatable. What is of interest is that, in a 1998 marketing and technical support documentation pack from a major electrostatic unit manufacturer, most of the information supplied related primarily to cooling water applications rather than boilers. The boiler data, such as there was, concerned only smaller, simple systems (e.g., HW boilers and steam ovens). 

EN 375 Information supplied by the manufacturer with in-vitro diagnostic... 

Other applications of commercial adsorbents are given in Table 17.1, taken from the work of Crtttenden(1). Some typical solvents which are readily recovered by adsorptive techniques are listed in Table 17.2, taken from information supplied by manufacturers. 

Patient information leaflets are intended to provide information about the medicine to the patient. The leaflets are produced for many medicines whether presented as original packs or patient packs. For medicines presented in bulk dispensing packs, the manufacturer may supply additional copies of the leaflet. Within the European Union, Directive 92/27/EEC outlines the contents of patient information leaflets and the use of the rINN is required. 

Information supplied by the manufacturer (this is discussed further below). 

Volume measurements include the use of pipettes, volumetric flasks, measuring cylinders, and burettes. Each has different calibration uncertainties that are detailed in the manufacturer s information supplied with the... 

Manufacturing information—information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug. 

Please note that any information supplied in this report related to corrective actions will be evaluated with the purpose of understanding the reason for the change to your device design, labeling, or manufacturing process. The information will not be evaluated for adequacy with respect to compliance with 21 CFR 820.100. 

Once the questioned ink has been identified, i.e., matched with a standard ink, the first production date of the standard ink can be determined from information supplied by the manufacturer. Inquiries carried out by the Bureau of ATF Identification Branch have shown that the various ink formulations change frequently, and every time a formula changes a date is provided... 

Safety information supplied by the manufacturer on a chemical container should be seen by students who actually use the chemical. If you distribute chemicals into smaller containers to be used by students, copy the hazard and precautionary information from the original label onto the labels for the students containers. Students interested in graphic design may be able to help you perform this task. Labels for many common chemicals may be found here http //beta.ehs.cornell.edu/labels/cgi-bin/label selection.pl... 

With due regard to technological feasibility, business operators shall have in place systems and procedures to allow identification of the businesses from which and to which materials or articles and, where appropriate, substances or products covered by this Regulation and its implementing measures used in their manufacture are supplied. That information shall be made available to the competent authorities on demand. 

Supplemental label element means any additional non-harmonized type of information supplied on the container of a hazardous product that is not required or specified under the GHS. In some cases this information may be required by other competent authorities or it may be additional information provided at the discretion of the manufacturer/distributor ... 

Additional incident information can be collected and statistics created from the perspective of timeframe (day of week, time of day, month of year), the type of unit operation (manufacturing plant, supply chain, transportation), the state of operation (normal, startup, shutdown, other), or different cause types (faulty equipment design, corrosion, failure to follow procedure, etc.). This can create a number of additional metrics. X... 

Section 8 of the DSHEA is a grandfathering clause. Substances in use prior to October 15, 1994 are not subject to the standard of reasonably expected to be safe. Substances marketed after this date are considered new dietary ingredients. Unless the dietary supplement was present in the food supply as an article used for food in a form in which the food has not been chemically altered, the manufacturer must notify the FDA at least 75 days before marketing the product. The manufacturer must supply the FDA with information based on history of use or other evidence of safety to support that the product will reasonably be expected to be safe for the stated use. There are no guidelines in the DSHEA for what constitutes history of use or other evidence of safety. - ... 

Based on information supplied by manufacturers, capital costs of wood gasification systems vary from approximately. 30- 1.10/ MJ/D ( 5,000 to 20,000/ODT/D) of capacity.(3) This wide variation is the result of differences in system capacity, inclusion of specific components, varying cost assumptions, and the requirement for land and facilities. The average costs are. 55-. 65/ MJ/D ( 10,000 to 12,000/ODT/D) for a system which includes materials handling equipment, gasification equipment and ancillary systems such as controls but excludes a boiler, land, building, contingencies and fees. 

The procurement agency should reserve the right to terminate the prequalification procedure of a product and manufacturer if the manufacturer fails to provide the required information in a specified time period, or if the information supplied is inadequate to complete the prequalification effectively. 

Manufacturers should be informed of tentative inspection dates, and should be requested to submit information about each manufacturing site to be inspected. This information should normally be provided in a site master file (SMF). An example of a technical questionnaire for pharmaceutical manufacturers is attached as Appendix 8. This information will be used during the preparation for the inspection and during the inspection itself to verify information supplied by the manufacturer to the procurement agency. 

The statements indicating action and use are largely based on the information supplied by the manufacturer. This information is merely meant to provide an indication on the potential use of new substances at the time they are accorded proposed INN. Because of their provisional nature, these descriptors will neither be revised nor included in the recommended and cumulative lists of INN. 

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