Practical compliance

Although this chapter deals with the subject of risk assessment, for the reader s convenience the wider issue of control measures following some types of assessment is also covered here. This is intended to avoid the need for constant reference to other chapters. 

The Control of Substances Hazardous to Health Regulations 2002 (COSHH) are very detailed, and contain several provisions which will not concern contractors directly. For practical purposes, they can be complied with by following seven basic steps  

The first step is to make a list of all hazardous substances which are likely to be present at work. The easiest way to do this is to collect the suppliers information on all the substances which have been bought for use, and read them. There may also be other potentially harmful substances which can be produced by the work process — welding rods which produce fumes for example and information on these should be obtained from standard reference sources. 

COSHH require that employers do not carry out any work which could expose employees to hazardous substances before carrying out a risk assessment. So, for each substance, it is necessary to think about the risks involved. If it is believed that there is no risk, or only a very small one, then no further action is needed. 

Employees and safety representatives should be involved in the process, as they often have practical information on risks at work which may not be known to management. The law requires that they are told about the results of the assessment. 

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The extent to which documents are reviewed will depend upon the results of the initial questionnaire responses, the interviews, and facility walk-around. In general, documents should be reviewed to verify good practice compliance, and a sampling will usually suffice. 

All UK facilities conducting regulatory studies must be members of the UK Good Laboratory Practice compliance program and all regulatory studies must be conducted... 

The top management of the organization produces the quality policy. This sets out the overall objectives of the quality management system. It should include reference to the management s commitment to good professional practice, compliance with the quality standard, and a framework for establishing and reviewing quality objectives. 

Meanwhile, to help eliminate teehnical barriers to pharmaceutical trade with the CEECs, protocols to permit mutual recognition of good manufacturing practice compliance for medicinal products are being negotiated. 

Good laboratory practice compliance with respect to image acquisition and storage is considered to be achievable. 

The previous section clearly indicates the need to conform to the principle of intention-to-treat to ensure that the statistical comparison of the treatment groups remains valid. In practice compliance with this principle is a little more difficult and the regulators, recognising these difficulties, allow a compromise. This involves the definition in particular trials of the full analysis set which gets us as close as we possibly can get to the intention-to-treat ideal. 

U.S. Department of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs, Bioresearch Monitoring (BIMO), Good Laboratory Practice, Compliance Program 7348.808. 

In practice, compliance with the published protocols and procedures is not simple and straightforward. Prior informed consent (PIC) is required for both an Academic Research Agreement (ARA) and a Commercial Research Agreement (CRA). However, in the case of the ARA, the application may be processed and the ARA may be executed without the PIC certificate, provided the certificate is acquired by the principal investigator/collector prior to the actual bioprospecting activity. 

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. 

The GAMP Forum identified the following common issues affecting practical compliance in 1999 and they are still very relevant today ... 

Good Laboratory Practice Compliance Facility Inspection 21 CFR Part 58... 

WHY IS GOOD DOCUMENTATION AND A GOOD DOCUMENTATION SYSTEM THE KEY TO GOOD LABORATORY PRACTICE COMPLIANCE ... 

National) GLP Compliance Programme The particular scheme established by a Member country to monitor good laboratory practice compliance by test facilities within its territories, by means of inspections and study audits. 

National) GLP Monitoring Authority A body established within a Member country with responsibility for monitoring the good laboratory practice compliance of test facilities within its territories and for discharging other such functions related to good laboratory practice as may be nationally determined. It is understood that more than one such body may be established in a Member country. 

Components of Good Laboratory Practice Compliance Monitoring Procedures... 

Practical Compliance with the EPA Risk Management Program, G-53, 1999. 

Good Laboratory Practice Compliance Inspection Manual... 

Member States, however, have to comply with the quality standards as set. As we have seen before, the means of enforcement for both the Commission and individuals of the EU standards on Member States have increased significantly only in the last few years. At the moment only a few cases are known of the enforcement by the Commission of practical compliance with quality standards on Member States via an Article 169 procedure and of individuals using the Francovich construction. However, as these enforcement procedures are developing rapidly, much will be expected from them in the future. 

Johnson, G. (1999) Waste Management for Northeast Caspian Drilling Programme, Best Practice Compliance with Environmental Regulations for Offshore Drilling Conference, Aberdeen, p. 53. 

Creedon, S.A. (2005) Healthcare workers hand decontamination practices compliance with recommended guidelines. Journal of Advanced Nursing, 51(3), 208-216. 

As used in the Regulations, the term compliance assurance has a broad meaning which includes all of the measures applied by a competent authority that are intended to ensure that the provisions of the Regulations are complied with in practice. Compliance means, for example, that ... 

Practical Compliance with the EPA Risk Management Program A CCPS Concept Book, Center for Chemical Process Safety, American Institute of Chemical Engineers, Wiley-AIChE, 2009. 

European Medicines Agency (EMA) (2012) Reflection paper on medicinal product supply shortages caused by manufacturing/good manufacturing practice compliance problems, 22.11.2012. http // www.ema.europa.eu/docs/en GB/document library/Other/2012/ ll/WC500135113.pdf. Retrieved 14 Apr 2013... 

Awareness for identification and treatment of risks Improvement Identification of opportunities and threats Compatible risk management practices Compliance of regulation and international norm... 

Safe work practices, compliance with safety rules... 

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