Manufacturing response

While the COA is the excipient manufacturer s responsibility, once the material is received, it is the drug product manufacturers responsibility to verify the product and ensure that it is properly tested, handled, and stored. Upon receipt of a shipment, each lot of excipient will be withheld from use until the lot is sampled, tested, or examined according to the written procedures. The quality control (QC) personnel will examine each container for (i) manufacturer s name, (ii) manufacturer s lot number, (iii) leaks or spills, (iv) contamination, (v) breached containers, (vi) proper labeling, and (vii) material safety data sheet and determined material hazards. 

The change in maintenance procedure was developed and implemented without the review and approval of the aircraft manufacturer responsible for the original maintenance procedure. One wonders if the accident could have been avoided if the developers of the change obtained the manufacturer s approval before implementing it. Had they done so, the problems with the change may have been identified and the change may have been rejected or refined. 

Some companies may think that they can get away with anything since they don t need the FDA s stamp of approval to sell their product. They re wrong. The Dietary Supplement Health and Education Act (DSHEA) of 1994 made it clear how the FDA is to control the supplement industry and check up on manufacturers responsibilities. The manufacturer is responsible for checking that the product is safe, even though it doesn t need FDA approval to be sold. Companies must also show scientific evidence to back up any claims they make. Any company that violates the rules is informed of its violation(s) and ordered to make changes. Companies that still fail to follow the rules face serious penalties that include having the products taken away, and possible criminal charges. 

Apart from the strictly regulated types of ingredients, colors, preservatives, and UV-filters, the main part can be used under the manufacturer responsibility. From the past we can get important toxicological aspects that ought to be noticed. In some cases toxicological problems have been discovered among constituents such as emulsifiers and emollients. 

From the outset our mission, enhanced by manufacturing responsibilities, required that our organizational structure should not be solely that of a service department for the Therapeutic Teams, and Discovery and Development departments, even though this was our primary mission. 

Also in February 2003, the European Union enacted the Directive on Waste Electrical and Electronic Equipment (known as the WEEE Directive), calling for manufacturers to take end-of-life responsibility for their products (European Parliament, 2003b). Until August 15, 2005, this directive applies the principle of collective producer responsibility to wastes generated by electrical and electronic products. This principle allows companies to pool monies used for managing their wastes. However, for wastes generated by products manufactured after that date, it applies the principle of individual manufacturer responsibility, with the result... 

Over the past 15 years, product liability claims and litigation against pharmaceutical manufacturers appear to have increased as measured by numbers of cases and changes in liability insurance. The legal circumstances under which courts hold pharmaceutical manufacturers responsible for injuries to consumers also broadened in recent years. 

Nevertheless, we re seeing more state-level legislation pushing extended manufacturers responsibility. These proposals would require manufacturers to fund and operate redemption centers for a wide variety of packaging. Proponents of these bills argue that they will increase the amount of material recovered for recycling, but as the Eu-... 

The Environmental Protection Agency (EPA) was established in 1970 to protect the environment from pollution. Initially, the EPA focused on recycling and cleaning up open dump sites, but today the government has passed over 12 environmental laws that impact air, water, and land. These laws hold the manufacturers responsible for the hazardous wastes they generate from cradle to grave. 

Using nonapproved components makes the pmduct manufacturer responsible. This includes responsibility for the component s design, construction, documentation, and ongoing compliance, areas where the end-product or machine manufacturer have no real control. 

The agreement includes (1) the manufacturers responsibility to state clearly on the operating conditions and abuse tolerance levels for the Li-ion cells they are producing and supplying for any application, and (2) the consumer s/end user s responsibility to ensure such Li-ion cells are being used as per the specified conditions. 

Any manufacturer response to previously reported failure or performance issues... 

Raising public awareness of solutions and problems associated with science and technology also becomes more pressing as engineering artefacts pervade more and more into our daily lives. A fine example of this linked into the recent European Union directive on managing waste associated with electronic and electrical equipment (WEEE). The legal aspects of this directive are profound making manufacturers responsible for the eventual disposal of... 

Japan is an example of a country replacing costly pre-market registration with manufacturer responsibility for product safety and post-market surveillance without compromising consumer safety. 

Environmental risk from partners is a powerful driver for restructuring the supply chain. There is growing recognition that issues of environmental pollution should be coordinated with the supply chain processes. Many European countries have enforced legislation that hold manufactures responsible for used-products and waste (Robeson et al. 1992 Fleischmann et al. 1997). Therefore, issues such as recycling, waste disposal, and control of industrial pollution must be addressed in an integral fashion (refer to Chap. 9). 

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