Distribution of documents

A master list or an equivalent document control procedure Identifying the current revision status and distribution of documents In the management system shall be established and shall be readily available to preclude the use of Invalid andfor obsolete documents. 

The timeliness of a manuscript is more important than its form which may be unfinished or tentative. Publication in this new series is thus intended as a service to the international scientific community in that the publisher, Springer, offers global promotion and distribution of documents which otherwise have a restricted readership. Once published and copyrighted, they can be documented in the scientific literature. 

Document management refers to procedures or systems designed to exert an intelligent control over the creation, management, and distribution of documents. Electronic document management systems (EDMS) may include any or all of the following features ... 

Controlled distribution of documents to, and retrieval by, multiple users... 

The methods that can be used to disseminate information among the local population include public meetings, audiovisual material, distribution of documentation (leaflets), and door-to-door visits (de las Alas, 1991). The best method probably combines aU these possibilities, as shown in Fig. 31.2. 

Documentation should be controlled in a consistent, compatible manner throughout the plant and the operating organization. This includes the preparation, change, review, approval, release and distribution of documentation. Lists and procedures for these functions should be prepared and controlled. 

The RMDB consists of two mayor sections computer data storage and retrieval system, and backup microfilm data bank file. The computer data storage and retrieval system is used for die standard reliability and maintainability data listing, special calculations, and searches. This data bank system has been established to facilitate remote terminal access compatible with the GIDEP remote terminal programs. The microfilm data bank file is used for storage and distribution of supplier s documents, failure analysis curves, description of methods used in the collection of the data, and additional background information too extensive to include in the computer data bank. 

Structure your documentation so that it consists of a number of volumes, each addressing a particular department or phase of operations. Limit the distribution of the relevant volume to staff affected and only keep one complete set. 

In the world of documents there are two categories those that are controlled and those that are not controlled. A controlled document is one where requirements have been specified for its development, approval, issue, revision, distribution, maintenance, use, storage, security, obsolescence, or disposal. You do not need to exercise control over each of these elements for a document to be designated a controlled document. Controlling documents may be limited to controlling their revision. On the other hand, you cannot control the revision of national standards but you can control their use, their storage, their obsolescence, etc. Even memoranda can become controlled documents if you impose a security classification upon them. 

The control which you exercise over external documents is somewhat limited. You cannot for instance control the revision of such documents therefore all the requirements concerning document changes will not apply. You can, however, control the use and amendment of external documents. You can control use by specifying which versions of external documents are to be used and you can remove invalid or obsolete external documents from use or identify them in a way that users know that they are invalid or obsolete. You can control the amendment of external documents by controlled distribution of amendment instructions sent to you by the issuing agency. 

The term issue in the context of documents means that copies of the document are distributed. You will of course wish to issue draft documents for comment but obviously they cannot be reviewed and approved beforehand. The sole purpose of issuing draft documents is to solicit comments. The requirement should be that the documents are reviewed and approved prior to use. Some organizations insist that even drafts are approved for issue. Others go further and insist that copies cannot be taken from unapproved documents. This is nonsense and not what is intended by the standard. Your draft documents need to look different from the approved versions either by using letter issue notation (a common convention) or by printing on colored or watermark paper. If the approved document would carry signatures, the absence of any signature indicates that the document is not approved. 

The DS team uncovered four additional sets of documentation systems when they conducted their detailed search of programs and elements. Each documentation system had its own set of standards for recording information, distribution, review and approval and for archiving. Furthermore, the incompatibilities of the various electronic systems were exacerbated by the lack of a corporate hierarchy on preferred computer platforms. 

Basic data collection procedures need to be comprehensive and formalized. They should address completion of the collection forms, the filing and distribution of these forms, and retention requirements of data source materials and other documents. 

Documentation is at the core of all quality systems, and was discussed in Chapter 2. Examples of the types of documentation associated with pharmaceutical production are shown in Figure 11.9. European regulations require that records which permit tracing of the full history for each batch of product should be retained for 1 year after expiry of the product or 5 years, whichever is the longer. US regulations require the retention of records for 1 year after batch expiry or 3 years after the last distribution in cases of some OTC products where no expiry date is assigned. Additionally, the US regulations require the preparation of a Master Production and Control Record ,... 

Arrangements for the preparation, revision and distribution of necessary documentation for manufacture. 

A system of documentation should exist such that the history of each batch of the product, including details of starting materials, packaging materials, and intermediate, bulk and finished products, may be determined. Distribution records must be kept. This information is of paramount importance should a defective batch need to be recalled. 

Countries nevertheless spell out their policy intentions in their dmg legislation, or incorporate their pharmaceutical policy into national planning documents. For example, Tunisia s national pharmaceutical policy is incorporated into its five-year economic development plan. In Malaysia, dmg legislation and regulations and a system for selection, procurement and distribution of essential dmgs all serve to describe that country s policy regarding the pharmaceutical sector. 

FIGURE 5.6 Example of improper manual application resulting in an inhomogeneous distribution of the sample over the entire length of the unacceptable band, documentation after chromatography at UV 366 nm. 

In 1975 the World Health Organization produced a guideline for the establishment, maintenance and distribution of chemical reference substances (WHO 1975). This document was intended to foster collaboration and harmonization of approval for the provision of reference substances by national authorities and organizations responsible for reference substances collections. This guideline was revised in 1982 (WHO 1982) and a further revision was completed more recently (WHO 1999) to take into account progress in pharmaceutical analysis. The latest guidehne defines both primary chemical reference substance and secondary chemical reference substance as follows ... 

Having RMs available is only one aspect, obtaining them is another. There are real difficulties in distribution of RMs through different Customs and Quarantine systems. These obstructions in movement of RMs are not only in the developing world, but also in aU global areas. Materials that cross international borders must be accompanied by a (or maybe 20 ) customs document. One of the key pieces of information on that document is correct allocation of the tariff number to the product. The customs tariff number directly impacts on the resolution of such matters as, most importantly, the rate of import tax and the speed through customs. Unfortunately at present there is no specific tariff number for RMs. For most producers, tariff niunber 382200000 seems to fit the biU. As discussed in Chapter 7, this issue will need to be resolved at International levels before easy movement and distribution of RMs can occur. 

The first step in a wildlife exposure assessment is to document the occurrence and persistence of a pesticide in the study area throughout the study duration. Several articles in this book describe the experimental designs and best practices to conduct field crop and environmental dissipation (air, soil and water) studies. This article presents methods to quantify spatial and temporal distributions of pesticide presence in ecosystems following normal application and resultant exposure of nontarget wildlife. 

GLP compliance for electronic records does not differ from GLP compliance for paper records. The increased access and distribution of records and documents enabled by electronic systems provide compliance challenges. There are many new questions to answer for example, what is the difference between electronic approvals and electronic signatures The solutions to these challenges lie in ensuring that system validation and management processes are in place, such as SOPs or procedures... 

In much the same fashion as the use of " Th/ U or Th/ Ra disequilibria, the extent and rate of °Po scavenging from seawater can be estimated by comparison of its distribution with that of its grandparent, °Pb. Early results documenting distributions of °Po and °Pb in the oceans (Bacon et al. 1976 1988 Thomson and Turekian 1976 Nozaki et al. 1976 Nozaki and Tsunogai 1976 Cochran et al. 1983 Chung and Finkel 1988 see also Cochran 1992) showed that °Po was more rapidly removed from surface waters than °Pb ( °Po/ °Pb in solution < 1). At depth, however, °Po can be released to solution from sinking particles such that °Po/ °Pb in solution is >1 (Cochran et al. 1983 Bacon et al. 1988 Cochran 1992). 

Evidence for the association of U with humic acids has been documented elsewhere. Dearlove et al. (1991) showed that U concentrated by ultrafiltration techniques from organic-rich groundwater samples were associated with humic colloids. Humic and fulvic acids have been shown to strongly complex U. Lienert et al. (1994) modeled the distribution of U species in the Glatt River and concluded that U-humate complexes become important at pH <6.8. These results reinforce the conclusions in the estuarine studies that U humate and fulvate complexes may account for the association of U with colloids. 

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