Current good Practice

Current good practice guidelines on how to effectively manage reactive hazards throughout the life cycle16 of a chemical manufacturing process are neither complete nor sufficiently explicit. 

In particular a number of current good practices are suggested as a means of focusing the orgaruzation s immediate actions to satisfy Part 11. The GERM guidance will be complemented by Models guidance on how to achieve practical compliance with a variety of computer systems. 

IT departments have traditionally not been directly worked in compliant environments and hence there is a lack of understanding in current good practices. Expectations from user and quality assurance groups will not be achieved unless there is a training program and culture change within the IT department. 

In summary, many of the requirements of a method development project are being dictated through regulation and internationally accepted guidelines, as well as a knowledge of current good practice accepted in the pharmaceutical industry. 

The consequence of a system failure today or in a system being declared noncompliant to current good practice by a regulatory authority is likely to be serious and may bring an entire site or a geographic region to a standstill. 

Pharmaceutical organizations that do not align their IT departments with current good practices will put in jeopardy all the good work undertaken by projects and users to validate individual applications. The need to have a compliant IT infrastructure should not be underestimated. 

Technical and managerial staff must be trained and able to demonstrate that they are competent in the procedures that are applicable to them. They must also have an appreciation of current good practices and how these impact their daily work. 

This EUROCOMP Design Code is the product of the work of the EUROCOMP Project Steering Committee, which represents Ae views of a wide body of designers, academic and manufacturing organisations as to what is considered to be current good practice. 

Having set the scene, the rest of the paper describes what EUROCONTROL, on the basis of collective experience of developing a number of Safety Cases, sees as current good practice, in the field of ATM. A fairly brief, theoretical treatment is supported by practical guidance and examples. 

This paragraph presents the essential points to be observed in the construction of Safety Arguments. The approach draws on current good practice without prescribing a particular methodology, and is supported by examples in the Appendix to this paper. 

Parts 2 and 3 of lEC 61508 (2000) provide a wealth of detail about good practice as it was some years ago but nevertheless provides a basis for questionnaires to update the measures and techniques to current good practice. 

Software reliability assessment is different from traditional reliability techniques and requires a different process. The use of development standards is common in current good practice. Software safety standards recommend processes to design and assure the integrity of safety-related software. However the reasoning on the validity of these processes is complex and opaque. 

The synthesis of chiral amines is important because many pharmaceuticals and other materials contain the amino (-NH2) functional group and current good practice requires that a single enantiomer be tested and sold. If synthesis of an amine where the nitrogen is attached to an asymmetrically substituted carbon is wanted, special techniques can sometimes be employed. 

A joint with a piastic waterstop and stainiess steei cover piate designed to ensure product and fire resistance to BS 476 - This meets current good practice and no upgrade would be required. It is unlikely to have a significant rate of iiquid egress from joint although loss of integrity of the plastic waterstop may eventually occur after protracted heat exposure. 

A LOPA considering the level of reduction of risk provided by secondary and tertiary containment requires a realistic case-by-case assessment which may take into account the extent to which measures comply with current good practice, the means of recovery of spilt material (if it is safe to do so) and the extent to which loss of integrity may occur for the event being considered. 

MOC processes which align to current good practice may be further improved using the UKPIA self-assessment tool, which provides a suitable methodology for advancing an organisation s MOC processes to achieve excellence in process safety. 

Dutyholders should ensure that written procedures are in place, and consistent with current good practice, for safety-critical operating activities in the transfer and storage of fuel. 

This ALARP assessment of the design of the APIOOO begins by exploring how the various standards defining current good practice have been applied to the design of the APIOOO. These standards are considered over three levels ... 

Conservators must know about the added material and its effects on objects before making a decision on whether, and how best, to incorporate a material into a treatment for the object Current good practice is to develop a treatment incorporating materials with appropriately specified properties, designed to fulfil a defined conservation need. It is not appropriate to apply a material designed for one purpose to another. 

Taped and sealed membrane to reasonable levels of workmanship/in line with current good practice with validation ° 0.5 The performance of membranes is heavily dependent on the quality and design of the installation, resistance to damage after installation, and the integrity of joints... 

Proprietary gas-resistant membrane to reasonable levels of workmanship/in line with current good practice under independent inspection (CQA) 1 ... 

Ground gas investigation to be in accordance with current good practice... 

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