Requests for production

Consumer information. Asking patrons, prescribers, and employees is another way to determine what to stock. Monitoring consumer requests for products is also helpful. 

This book describes more than 3,150 textiie finishing chemicais which are currently available for industrial use. The book will be of value to technical and managerial personnel involved in the specification and use of textile finishing chemicals. It has been compiled from information received from 74 manufacturers and distributors of these chemicals, who responded to our requests for product information. 

All requests for products should include quantities and required delivery dates. Accurate quantification of needs is essential to avoid shortages or excess stocks. Shortages could lead to patients not being treated or being improperly treated. Excess stocks could lead to additional storage costs and expiry of products before they are used. 

In the apparel industry, production orders tend to split into smaller orders with different product features in response to growing requests for product customization. In order to shorten product time-to-market, apparel manufacturers work hard in the direction of just-in-time production. In the apparel manufacturing process, the effectiveness of fabric-cutting schedule planning extensively influences downstream assembly operations, and thus, in turn, is critical to the overall system performance. However, the demand from downstream operation... 

The idea of having available rapid methods to respond to requests for product sensory information is, as already noted, essential. However, such a resource means having subjects who have the necessary sensory skill and experience to provide information that can be relied on. This also means that one should not select subjects at random or use software for analysis that is not understood. While some legacy methods require many weeks of training, some do not. The sensory staff has to decide what is the best approach to take in developing capabilities so that best use is made of available resources. The choices are documented here along with reference to where more details can be found. 

Congress has provided FDA authority under the FD C Act and the Public Health Service (PHS) Act to regulate products regardless of how they are manufactured. Each request for product approval is considered using the appropriate statutory and regulatory criteria. The following sections summarize general requirements for various kinds of products. 

Order capture processes enter customer s request for products. It does so using a standard interface platform. Order validation creates the library of business and technical rules that can be used to determine if an order is valid and should be accepted for further processing. For example, business rules define possible actions on customer s credit limit and/or the contractual terms. Technical rules define availability of services needed to complete the order in the customer s premises. Order decomposition provides a mechanism to generate multiple sub-orders based on the product definition (product decomposition) or based on the delivery location (work order decomposition). For example, a customer may order a broadband... 

We all have needs, requirements, wants, and expectations. Needs are essential for life, to maintain certain standards, or essential for products and services, to fulfill the purpose for which they have been acquired. Requirements are what we request of others and may encompass our needs but often we don t fully realize what we need until after we have made our request. For example, now that we own a mobile phone we discover we really need hands-free operation when using the phone while driving a vehicle. Hence our requirements at the moment of sale may or may not express all our needs. Our requirements may include wants - what we would like to have but do not need nice to have but not essential. Expectations are implied needs or requirements. They have not been requested because we take them for granted - we regard them to be understood within our particular society as the accepted norm. They may be things to which we are accustomed, based on fashion, style, trends, or previous experience. Hence one expects sales staff to be polite and courteous, electronic products to be safe and reliable, policemen to be honest, etc. 

Request for Quotation (RFQ) To obtain prices for products/services V V ... 

Regarding concessions you will need to register all requests for concessions to product requirements and carry out a periodic analysis to detect trends. Is it always the same product, the same requirement, the same person or are there other variables that indicate that the requirements are unachievable and in need of change Under ideal conditions there should be no need for requesting concessions. The process should be fully capable for producing the goods. But if it happens frequently, there may be some underlying cause that has been overlooked. 

Figure 7.2 Information supplied to the CVB in support of a request for authorisation to ship an experimental biologic product.

For non-prescription and generic dmgs, the documentation required is simplified and is mostly concerned with chemical and pharmaceutical data. In general, the documentation required for registering products containing new chemical entities is more extensive than that for products in other categories (see Table 8.2). Countries that have the capacity to make an independent assessment of the safety, efficacy and quality of products, such as Australia, Estonia and the Netherlands, do not request the WHO-recommended Certificate of Pharmaceutical Product. Only Cyprus and Tunisia request price information. 

The conduct of clinical trials is regulated in all the countries, except Cypms. In Cypms, the policy of the Ministry of Health is not to permit clinical trials for experimental medical products. Multicountry clinical trials for products licensed in developed countries are undertaken in some institutions and regulated by ethics committees (Table 8.5). In these countries, approval of clinical trials is carried out either by the DRA, as in Estonia, Malaysia, Tunisia, Venezuela and Zimbabwe, or by ethics committees. When the DRA itself is responsible for control, information about the trials is processed centrally. In Tunisia, clinical trials form part of the registration process. Trials are requested, when deemed necessary, by the specialized committee charged with reviewing the new dmg. The trial proposal is then evaluated by the technical committee, and forwarded to the Health Minister for final approval. Cuba has a National Centre for the Coordination of... 

Policy on Period of Marketing Exclusivity for Newly Approved Drug Products with Enantiomer Active Ingredients Request for Comments, (1997) Docket No. 97N-0002. 

Stable expression of the recombinant protein is another pre-requisite. For production in CHO cell culture, narrow specifications of expression level are requested by the FDA. Consequently, plant-derived proteins need to be produced according to a defined scheme and within defined specifications in order to generate material suitable for clinical trials. Therefore, the expression level must be maintained within a defined range. For example, Prodigene Inc. assessed whether the E. coli Lt-B protein was uniformly distributed throughout the defatted maize germ by analyzing samples... 

A process order is a request asking production to produce a specific quantity of a material on a specific date. Creation of a process order uses a master recipe that is valid for the specific material and quantity as a template to determine the specific timing and component quantities (material flow). 

The authors describe experiments on six NR compounds commonly used for latex gloves to determine the potential hazards of skin contact with reference to curing compounds and accelerators, including mercaptobenzthiazole and zinc dialkyldithiocarbamates. Simulation methods and the influence of a common hand disinfectant were investigated. In the case of tetramethylthiuram disulphide, it was discovered that decomposition products could be formed on the skin which are not present in the original rubber. 6 refs. Articles from this journal can be requested for translation by subscribers to the Rapra produced International Polymer Science and Technology. Accession no.849747... 

I mentioned three factors in federal law which impact on this disclosure problem. The first is that the Freedom of Information Act makes it difficult to withhold information. It does this both by an uncertain standard of confidentiality, and by the omission of the procedural protection which comes with all other kinds of adjudicative decisions by federal agencies. The courts rewrote the Freedom of Information Act s original intent in the 1974 National Parks v. Morton decision. Since that time, each submission to an agency has been vulnerable to disclosure if the owner fails to carry a rather difficult burden of proof That disclosure would cause substantial harm to competitive position at the time the disclosure is made. Assume that the owner of a secret catalyst had a market share of 10 in specialty fatty acids for rubber production, and filed the catalyst information with the EPA on April 1, 1982. When the request for disclosure comes in November 1983, what will the firm s market position be then, and how much would this... 

The second major change enacted under the 1962 amendment was the change in the approval process from premarket notification to a premarket approval system. Under the terms of the 1938 law, an NDA would take elfect automatically if the FDA did not respond. For example, the only reason thalidomide was not approved was because Dr. Kelsey returned the application to the sponsor with a request for more information. In contrast, the 1962 law required affirmative FDA action before a drug could be put on the market. Under the terms of the 1962 amendments, the FDA was also empowered to withdraw NDA approval and remove the drug from the market for a variety of reasons, including new evidence that the product was unsafe or that the sponsor had misrepresented or under-reported data. 

The FDAMA bill essentially codified and expanded several regulatory actions initiated by the FDA during the 1990s. Among the incentives offered by the bill, companies will be offered an additional six months of patent protection for performing pediatric studies (clinical trials) on already approved products. In fact, the FDA was mandated by FDAMA to develop a list of over 500 drugs for which additional information would produce benefits for pediatric patients. The FDA is supposed to provide a written request for pediatric studies to the manufacturers (Hart, 1999). 

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