Prescriptive documents

These lists tell us something about the nature of quality records, especially by what is not included. Absent from the lists are policies, procedures, instructions, plans, specifications, and any other prescriptive documents. The records all have one thing in common they describe the results of some activity - the results of inspections, tests, reviews, audits, assessments, calculations, etc. However, these lists are dominated by records relating to product quality rather than to the operations of the quality system. In addition to audit records, the following records may need to be maintained to demonstrate the effectiveness of the quality system ... 

Electronic support system for correct prescription, documentation and communication. 

It appears that the type of corrosion (uniform, pitting) and potential consecpiences of failure should be taken into account in the recommendations for the crack width limits given in the current prescriptive documents. The crack width limits recommended for the assessment of the residual working life of a bridge should be further analyzed. 

The assessment of existing structures including heritage ones differs in many aspects from the procedures taken during the design of new structures and may require the application of sophisticated methods, in many cases beyond the scope of common standards for structural design. The prescriptive documents used for the design or verification of new structures cannot be directly applied to the assessment, as the actual state of the structure and its materials must be considered. Moreover, the current standards have often more severe requirements than the standards that were applied at the... 

ABSTRACT Retention levels of road safety barriers are specified on the basis of risk assessment taking into account accidental data and further information available in the Czech Republic and also selected recommendations of Road Safety Association PIARC. The method of Bayesian networks is applied in the analysis and compared with event tree method. Newly proposed classes of retention for several categories of road surroundings considering the intensity of heavy traffic and two levels of hazard situation are incorporated to the revision of national prescriptive document that is expected to enhance the road safety. 

Thousands of human lives are annually lost on European roads. Therefore, the authorities in most countries are concerned about the numbers of people killed and injured, leading to enormous social and economic costs. In the Czech Republic, more than 85 people per one million inhabitants lose their life annually. It means that on the average 897 people was killed per year in the last ten years. It should be noted that the number of fatalities are below the mean in the last 5 years. Protective measures have significant influence on reduction of consequences of car accidents. Various national or European prescriptive documents give basic guidance for their application. 

The capacities of safety barriers for several levels of retention N1 to H4b are given in Table 1 according to standard EN 1317-1 and national prescriptive document TP 114. 

Risk assessment based on accidental data for motorways and main roads facilitates to propose new retention levels of safety barriers to the revision of national prescriptive document TP 114. 

The reason for an Exposition is so that there is a description of the system showing how it works and how it controls the achievement of quality. This is different from the policies and procedures. The policies are a guide to action and decision and as such are prescriptive. The procedures are the methods to be used to carry out certain tasks and as such are task related. They need to be relatively simple and concise. A car maintenance manual, for example, tells you how to maintain the car but not how the car works. Some requirements, such as those on traceability and identification, cannot be implemented by specific procedures although you can have specific policies covering such topics. There is no sequence of tasks you can perform to achieve traceability and identification. These requirements tend to be implemented as elements of many procedures which when taken as a whole achieve the traceability and identification requirements. In order that you can demonstrate achievement of such requirements and educate your staff, a description of the system rather than a separate procedure would be an advantage. The Exposition can be structured around the requirements of ISO/TS 16949 and other governing standards. It is a guide or reference document and not auditable. 

The requirements of clause 4.5 therefore apply to policies and practices, derived documents, and external documents that are prescriptive but not descriptive. The descriptive documents are covered by clause 4.16 on quality records. 

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. 

In the United States, concentrations range from 2% (over-the-counter) to 4% (by prescription). Higher concentrations can be compounded by pharmacists for stubborn cases of hyperpigmentation. Multiple studies have documented the efficacy of hydroquinone formulations [44]. 

The main process (Fig. 1.1) for the care of a patient is normally the Primary care process (the patient handles their own drugs)—or the community care process (the patient gets help from community nurses at home or at a nursing home). All other processes such as hospital care (secondary/tertiary care) and the pharmacy process must support the main patient process. For improvement we must focus on patient safety and reduce drug-related problems. This means correct prescription and correct use (follow-up, documentation and communication) from the supportive process to the main process. 

Antidepressants. The tricyclic antidepressant desipramine has shown some small success in reducing cocaine craving, but the results are not overly impressive, and desipramine has many well-documented side effects and is dangerous in overdose (see Chapter 3 for more information). Cocaine-abusing patients who are not highly motivated will usually not remain adherent to the desipramine prescription. We do not recommend desipramine for the nondepressed cocaine addict. 

The definition of promotion under the Code is broad and is designed to encompass any activity undertaken by a pharmaceutical company or with its authority that promotes the prescription, supply, sales or administration of its medicines. Within that definition, there are a number of exclusions from the scope of the Code such as trade practices and trade advertisements. The content of data sheets and SPCs is also excluded from the scope of the Code, as they are documents... 

For purposes of enforcing the law, FDA inspectors may at any time inspect any non-prescription or prescription drug. For both, FDA inspectors may see all records and documents except those that relate to financial data, sales data other than shipment data, pricing data, personnel data and research data. An FDA inspector may spend whatever amoimt of time is necessary to complete such an inspection - even weeks or months. Where significant enforcement issues have been found, FDA inspectors have been known to spend more than a year at a single establishment. 

In June 2004 the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) were issued by the TGA to replace the AGRDl. Under the ARGPM the format for registration applications in Australia is the Common Technical Document (CTD) developed through the International Conference on Harmonisation (ICH). 

The yellow self-adhesive Accutane qualification sticker documents that the female patient is qualified and includes the date of qualification, patient gender, cut-off date for filling the prescription, and up to a 30-day supply limit with no refills. 

Rettig, R. A., The Implementation of the Prescription Drug User Fee Act of1992 by the Food and Drug Administration, RAND, unpublished document. 

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