Product file contents

As a potential product moves through the various developmental stages, information is continually generated and incorporated into a master documentation file. When the validation runs are planned for the final process, they will be based on the master documentation file contents. The information generated during the validation runs is usually the last major item to go into the master documentation file. 

While TOXLINE/TOXBACK are bibliographic retrieval services, the third file to be briefly described in this paper can be considered an on-line data retrieval file. RTECS (Registry of Toxic Effects of Chemical Substances) is a product of the National Institute for Occupational Safety and Health (NIOSH) and is available as an annual publication (.2). NLM obtains a computer-readable file from NIOSH who maintains responsibility for file contents. The present (1977) version of RTECS contains toxicity data for approximately 26,000 substances. Table 1 provides a description of an RTECS unit record. 

Shen L, Haufe J, Patel MK (2009) Product overview and market projection of emerging biobased plastics (PRO-BIP 2009). EPNOE, Paris, http //www.epnoe.eu/content/download/ 7670/109501/file/PROBIP2009%20Final%20June%202009.pdf... 

Before the end of phase 3, a decision is taken whether or not to file the compound, what the content and message of the dossier and what the regulatory strategy will be. Also the final decisions will be made on the production for marketing and on the anticipated pre-marketing requirements. This is the pre-filing decision point. 

Mix 3 gm. of flowers of sulphur with 3 gm. of iron powder or clean iron filings, and heat half of the mixture in an old test tube. As soon as there is decided evidence of chemical action, remove the test tube from the flame. When the tube has cooled, break the end by rapping it sharply on a hard surface. Examine the contents. What is the evidence of the formation of a new compound Verify the conclusion by adding a little dilute hydrochloric acid to the product and then to the remainder of the original mixture, testing the gaseous product in each case by the odor. 

As recommended by file ICH, the usual range for the potency assay of a drug substance or a drug product should be 20% of the target or nominal concentration and 30% for a content uniformity assay. At least five concentration levels should be used. Under normal circumstances, hnearity is achieved when file coefficient of determination (r ) is >0.997. The slope, residual sum of squares, and... 

An efficient approach to this problem is to separate the house organs worthy of consideration into those equivalent to journals and those equivalent to trade publications in terms of content. The house organs considered equivalent to journals then should be given the necessary time and attention. They should be included with the journals in evaluation of articles for the internal literature abstracting service and for the file of articles of importance to a company s products, processes, and fields of interest. Retention schedules must be established in much the same manner as for journals. A few house organs will be bound. The important articles in those not bound should, of course, be clipped and retained in some accessible form. House organs adjudged to be equivalent to trade publications should be so treated. 

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