Document, commissioning

Furthermore, the ISPE Baseline Guide, Commissioning and Qualification [5] emphasises the need to undertake qualification practices only for equipment and system component parts and functions that could directly impact quality attributes of a product or process. Other components and functions are to be dealt with under good engineering practice (GEP) [3,5] throughout the system life cycle, undergoing an appropriate level of documented commissioning. 

For this purpose a well planned, controlled and properly documented commissioning programme should be prepared and made ready for implementation. The proposal of the commissioning programme should be presented in this chapter of the SAR. A clear link from the plant safety justification to the commissioning programme should be demonstrated. 

A records administration and documentation system should be established to ensure the appropriate keeping of all documents relevant to the safe and reliable operation of the plant, including design documents, commissioning documents, and... 

The ECPI approach has been adopted by the European Commission in their "Technical Guidance Document on the Risk Assessment of Notified New Substances" as the model for assessment of environmental exposure from additives in plastics. It is important to note, however, that due to the effect of ultraviolet degradation and microbial attack, a significant proportion of the emissions from flexible PVC consists of plasticizer degradation products. In these instances, therefore, the level of plasticizers appearing in the environment will be significantly less than indicated by the plasticizer loss data. 

Interstate Commerce Commission Reports, Supetintendent of Documents, U.S. Government Printing Office, Washiagton, D.C., cited (Volume) ICC (Page). A series of decisions of the now defunct Interstate Commerce Commission Vol. 1 was pubHshed 1887. 

A number of subdivisions of the maceral groups have been developed and documented by the International Commission on Coal Petrology (14). Table 1 Usts the Stopes-Heeden classification of higher rank coals. Periodic revisions include descriptions of the macerals, submacerals, morphology, physical properties, and chemical characteristics. Theories on the mode of formation of the macerals and their significance in commercial appUcations are also included of Reference 14. 

U.S. Htomic Energy Commission Document 1174-71, U.S. Government Printing Office, Washington, D.C., 1971. 

Technical Guidance Document in Support of the Commission Directive 93/67/EEC on Risk. Assessment for New Notified Substances and the Commission Regulation (EC) 1488/94 on Risk Assessment for Existing Substances, European Commission, 1996. 

You should develop a documented procedure for the facility planning activity that will ensure the provision of adequate information on which to base plant design decisions. The procedures should provide for a separate development plan with allocation of responsibilities for the various tasks to be undertaken and should cover the layout, specification, procurement, installation, and commissioning of the new or revised plant. 

Produce procedures for introducing, commissioning, qualifying, changing, filing, and withdrawing quality system documents. 

All processes and equipment should be proven capable of performing the task for which they were designed and so should either be subject to qualification tests or process capability tests. There may be documentation available from the supplier of the equipment which adequately demonstrates its capability, otherwise you may need to carry out qualification and capability tests to your own satisfaction. In the process industries the plant is specially designed and so needs to be commissioned and qualified by the user. Your procedures need to provide for such activities and for records of the tests to be maintained. 

Leverenz, F. L. and D. C. Cox. Probabilistic Risk Assessment Course Documentation, Volume 6, NUREG/CR-4350, U. S. Nuclear Regulatory Commission, Washington, DC, 1985. 

Inspection period. All relevant documents, the installation and its components are visually and physically examined, with all energy sources isolated. The commissioning program is finalized. 

Members of the Commission (JCBN) at various times during the work on this document (1983-1996) were as follows ... 

These Recommendations expand and replace the Tentative Rules for Carbohydrate Nomenclature [1] issued in 1969 jointly by the IUPAC Commission on the Nomenclature of Organic Chemistry and the IUB-IUPAC Commission on Biochemical Nomenclature (CBN) and reprinted in [2]. They also replace other published JCBN Recommendations [3-7] that deal with specialized areas of carbohydrate terminology however, these documents can be consulted for further examples. Of relevance to the field, though not incorporated into the present document, are the following recommendations ... 

Not all problems were solved, however, and different usages were encountered on the two sides of the Atlantic. A joint British-American committee was therefore set up, and in 1952 it published Rules for Carbohydrate Nomenclature [18]. This work was continued, and a revised version was endorsed in 1963 by the American Chemical Society and by the Chemical Society in Britain and published [19]. The publication of this report led the IUPAC Commission on Nomenclature of Organic Chemistry to consider the preparation of a set of IUPAC Rules for Carbohydrate Nomenclature. This was done jointly with the IUPAC-IUB Commission on Biochemical Nomenclature, and resulted in the Tentative Rules for Carbohydrate Nomenclature, Part I, 1969 , published in 1971/72 in several journals [1]. It is a revision of this 1971 document that is presented here. In the present document, recommendations are designated 2-Carb-n, to distinguish them from the Carb-n recommendations in the previous publication. 

We would like to gratefully acknowledge EMEA, ISO, EDQM, PIC/S, IMB, ISPE and Health Canada that granted us permission to reproduce selected copyrighted material. We reserve a special acknowledgement and thanks to the European Commission, the FDA and the ICH secretariat, the VICH and the GHTF, who have placed their regulatory documentation in the public domain, and we have reproduced several documents from these sources herein. 

CEC (2003) Technical guidance document on risk assessment in support of Commission Directive 93/67/EEC on risk assessment for new notified substances and Commission Regulation (EC) No 1488/94 on risk assessment for existing... 

World Commission on Environment and Development (1987) Report of the World Commission on Environment and Development Our Common Euture. Transmitted to the General Assembly as an Annex to document A/42/427 - Development and International Co-operation Environment. http //nnnv.un-documents.net/wced-ocf.htm. (Accessed May 2010). 

Plant must be properly designed, installed, commissioned, operated and maintained. Depending upon the risk, working procedures should be documented, e.g. as codes of practice. 

European Commission (1993) Guidelines for the production and preparation of BCR reference materials. Document BCR/48/93. DG XII, Brussels, Belgium. 

Commission Directive 96/46/EC of 16 July 1996, amending Annex II to the Directive 91/414/EEC, is the basis for the assessment of residue analytical methods for crops, food, feed, and environmental samples." Provisions of this Directive cover methods required for post-registration control and monitoring purposes but not data generation methods. Because it is necessary to provide applicants as precisely as possible with details on the required information, the guidance document S ANCO/825/00 rev. 6 dated 20 June 2000 (formerly 8064/VI/97 rev. 4, dated 5 December 1998)" was elaborated by the Commission Services in cooperation with the Member States. 

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