Product file

C. Testing Requirements for Drug Products Filed in the United States and Outside the United States... 

If any later-filed generic applicant filed its ANDA with the requisite certification after January 1, 1992, even if the first generic applicant for a particular drug product filed its application prior to January 1, 1992, the drug product was included within the scope of the study. 

Stark, J. C, Olsen, N., Kleinkopf, G. E. and Love, S. L. Tuber Quality, (2003a) www.ag.uidaho.edu/potato/ production/files/TUBERQUALITY-web.pdf... 

Fig. 26. The production of heavy water is based upon the behavior of deuterium in a mixture of water and hydrogen sulfide. When liquid H2O and gaseous H2S are thoroughly mixed, the deuterium atoms exchange freely between die gas and file liquid. At high temperatures, file deuterium atoms tend to migrate toward file gas, while they concentrate in file liquid at lower temperatures. In the first and second stages of production, file towers of a heavy water plant are operated with the top section cold and file lower section hot. Hydrogen sulfide gas is circulated from bottom to top and water is circulated from top to bottom through the tower. In the cold section, the deuterium atoms move toward file water and are carried downward, while in file hot section, they move toward the gas and are carried upward. The result is that, both gas and liquid are enriched in deuterium at the middle of the tower. A series of perforated trays are used to promote mixing between the gas and water in the towers. A portion of the HjS gas, enriched in deuterium, is removed from file tower at the juncture of file hot and cold sections and is fed to a similar tower for the second stage of enrichment...

Isomeric states are denoted by the symbol "m after the mass number and are given in the order of increasing excitation energy. The 235U thermal fission products, with fractional cumulative yields>10, are italicized in the table. The information on fission products is taken from the ENDF/B—VI fission products file [8],... 

For products that are prepared extemporaneously at a regular basis or even for a limited stock, a product specific documentation (product file) is needed. This will include specifications, instructions, and records but also a pharmaceutical assessment of safety data, toxicity, biopharmaceutical aspects, stability, and product design. The product file should also include a product review as soon as a product is used repeatedly or over longer periods. 

Staff shall handle product files with care and treat all information as confidential relating to the task to be performed. 

Submit a product dossier in the recommended format as specified in the Guideline for submission of a product file which can be obtained by electronic mail from oakesl who.int, also available on the the web page http //mednet3.who.int/prequal. The dossier should be accompanied by a sample of the product to enable analyses (e.g. 1 x 100 tablets). 

Each product file submitted by an interested manufacturer should be assessed as part of the prequalification process. 

Each product file should go through a screening procedure. 

Product files found to comply with the screening requirements will be retained for assessment. 

The objective is to screen product files to determine whether these comply with the requirements. This will prevent loss of valuable assessment time, should the product files be incomplete when received. 

Unpack each product file onto the working surface in the presence of at least two other persons. Sign a sheet indicating the names of the persons responsible for opening the containers on that date. 

Write the product number on the product file and screening form for the product. 

Screen the product file to assess its completeness. Confirm that all the required information, data and forms have been submitted by the manu-facturer/sLipplier. 

Place the original of the completed screening form in the front of the product file. 

If the product file is complete, place the product file in numerical order in the designated area marked For evaluation . 

If the product file is incomplete, place the file in the designated area, marked Incomplete files . 

For each product file received, send a letter of acknowledgement of receipt to the manufacturer. For an Incomplete file , inform the manufacturer... 

Note Each product file must be assessed by at least three evaluators. 

Take a product file from the section marked For evaluation . 

If you are evaluating Part 2, Bioequivalence (safety and efficacy) , and the efficacy part of the dossier is not included for all oral preparations, except aqueous solutions, at the time of administration, inform the manufacturer in writing that the product file was submitted without bioavailability aspects and cannot be evaluated at present. 

Thank you for submitting a product file after having indicated your company s interest in supplying drug products as part of the prequalification process of drug products to the United Nations organizations and interested procurement agencies. 

Kindly note that your submission was found to be incomplete. We therefore regret to inform you that no further evaluation will take place with regards to your product file, and that the manufacturer will be not be included in the prequalification process. Would you kindly contact this office within 30 days to enable us to make the necessary arrangements for the return of the information already submitted. 

The report should be signed off by the person responsible for the evaluation and assessment of the product files. 

NDMA is not produced for commercial use in the United States (HSDB 1988). The public portion of the U.S. EPA TSCA Production File indicates that during 1977, the Ames Laboratories in Milford, CT and Columbia Organics in Columbia, SC both prepared small research quantities of this chemical. Eastman-Kodak in Rochester, NY and Teledyne McCormick Selph, an importer, supplied no NDMA during 1977, although both had the capability to produce/import this compound and had done so in the past (EPA 1977). Small research quantities of this chemical presently are available from Sigma Chemical Co. and Aldrich Chemical Co. NDMA can be prepared by reaction of nitrous acid with dimethylamine or by addition of acetic acid and sodium... 

TRI discharges to all media Air Products file annual figures to the US federal government on Toxic Release Inventory (TRI). The internet report lists releases of each reported chemical for 1998 by media. In both the internet and short CER comparative figures are presented for the past ten years for air-sensitives, releases to the environment and for discharges from Air Products facilities (including transfers for off-site treatment). 

The analysis found 85,694 different Federal product liability cases involving a total of 19,456 lead defendants. Pharmaceuticals and health care products represented 13.5 percent of the total cases but only 2.2 percent of the total number of defendants. Of the 11,292 suits for pharmaceutical and other health products filed, 72 percent are attributable to five fins, and 60 percent are attributable to two companies-A H. Robins and Merrell Dow Pharmaceuticals.9Figures 7-1 and 7-2 show trends in these cases over time. 

R.U.P. 1994. EPA Restricted Use Products File. Washington DC U.S. Environmental Protection Agency, Office of Pesticide Programs (on-line BBS database). 

I = Reference samples used to construct the product file within a library... 

Documentation supporting these activities are collected in the Product Files and finalized in the Process Release and/or Technology Package. 

The ECDIN database consists of a set of ADABAS files. There are more than 30 production files and a similar number of files used for new developments. Each of the... 

Service Historique de I Armee de Terre (SHAT), Vincennes, ION 185, (Commission of Inquiry into State Contracts, Chemical Products, File on stilphtrric acid, 65-66°. Contract between the State and Kuhlmann on 24 October 1915). EtabUssements Ktrhlmann declared that it had taken out an option to acquire 16.5 hectares of land situated on the seafront at Port-de-Bouc. The cost of setting up operations was estimated at FF6 million. 

Product files for pharmacy preparations are described in Sect. 33.8. National formularies such as FNA (see Sect. 39.4.5) and NRF (see Sect. 39.4.2) entail the product and process design of a large number of standard pharmacy preparations. These formularies contain the description of the formulations and method of preparation, as well as elaborate elucidations on them. Many of these elucidations reflect the QbD ideas about documentation of the design process, friformatimi about product quality, efficacy, and safety is published in those formularies or in other clearly related sources information leaflets for the patient or clinical informatimi booklets for physicians. 

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