Risk assessment process reviewing documents

US-EPA has formed the Risk Assessment Forum, a standing committee of senior US-EPA scientists, to promote US-EPA consensus on difficult and controversial risk assessment issues and to ensure that this consensus is incorporated into appropriate US-EPA risk assessment guidance. To fulhil this purpose, the Forum assembles US-EPA risk assessment experts in a formal process to study and report on issues from a US-EPA scientific perspective. Major Fomm guidance documents are developed in accordance with the US-EPA s regulatory and policy development process and become US-EPA pohcy upon approval by the Administrator or the Deputy Administrator. The Risk Assessment Forum products include risk assessment guidelines, technical panel reports on special risk assessment issues, and peer consultation and peer review workshops addressing controversial risk assessment topics. 

In the present chapter, the pharmaceutical industry validation system has been reviewed. To have an appropriate validation system it is first required to define which equipment, facilities, and processes will be validated, when they will be validated, and by whom this must be performed. This definition is based on a risk assessment priority and is written in a specific document, the so-called MVP. In order to generate an adequate validation report, all the validation activities should be described in the validation protocols, SOPs, and specific procedures. 

Preparation of standard procedures Document review Validation glossary Critical parameter assessment GMP criticality and risk analysis Process validation methodology Computerized system validation Preparation of validation plans Preparation of project and quality plans Manufacturing data specification... 

Transparency of documentation is also critical to adequate review of the uncertainty analysis by peers, an integral component of a defensible process for exposure and risk assessment. Selected peer reviewers must have representative expertise, which may include, but may not necessarily be limited to, analysts, exposure assessors, statisticians, etc. 

User Interface. The object of software systems for risk assessment is to make the process of generating or reviewing risk assessments easier for system users. Software that is not easy to learn or use, or that requires constant reference to manuals or other support documents, will do little to help risk assessors faced with a demanding workload. Accordingly, a key emphasis in the development of Risk Assistant is that the software be usable by persons with little or no computer experience, without the need for training, and that the majority of a user s questions can be answered in the software, without the need to refer to manuals. The development of technical manuals is an important part of the Risk Assistant effort, but the user should not need to refer to these manuals frequently. 

It is very likely that during the inspection historical events of the above-mentioned topics will be surveyed and it is expected that the involved persons have evaluated the processes with scientific expertise and appropriate risk assessments. A controlled, informed, and trained handling of these critical issues is mandatory. Compliance with set review-cycles for specification-documents will be checked randomly and should be considered in the preparation phase of the inspection. 

The assessment should be recorded to document the conditions foxmd -both good and bad - and the actions that were judged to be necessary to reduce any risk. If conditions change within the plant or process, the COSHH assessment should be reviewed and may need to be repeated. Advice and guidance on carrying out risk assessments are contained in HSE publications. ... 

In general, prior approval must be obtained when a laboratory procedure presents a significant risk of injury, illness, or exposure to hazardous substances. The risk is considered significant when there are very large quantities of particularly hazardous substances involved or the experimental procedures exacerbate the potential for a hazardous condition. These conditions must be applied on a case-by-case basis. The process of documented assessment ensures that all relevant safety parameters are met, including training. The documentation used is summarized in Table III. The information is completed and reviewed by the Principal Investigator and the Unit Safety Committee. 

A cross-functional committee should be used to conduct job risk assessments, reviewing loss history, job related documents, interviews, and overall data collection. The committee directs the JHA process through the following ... 

Thus, the risk analysis must be well prepared, meaning that the scope of the analysis must be clearly defined data must be available and evaluated, to define the safe process conditions and the critical limits. Then, and only then, the systematic search for process deviations from the safe conditions can be started. The identified deviations lead to the definition of scenarios, which can be assessed in terms of severity and probability of occurrence. This work can advantageously be summarized in a risk profile, enhancing the major risks that are beyond the accepted limits. For these risks, reduction measures can then be defined. The residual risk, that is, the risk remaining after implementation of the measures, can be assessed as before and documented in a residual risk profile showing the progress of the analysis and the risk improvement. These steps are reviewed in the next sections. 

A fundamental feature of the process of review and assessment of an application for authorization by the regulatory body is its consideration of the documentation submitted by the applicant. For significant risk sources or unusual or complex practices, the regulatory body should also verily the contents of the documents submitted by means of inspection of the site where the radiation sources are to be installed or used. These inspections will also allow the regulatory body to supplement the information and data needed for... 

QRM finds its way into medicines regulations as it is seen as a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. A structured and documented management of risks is a requirement in EU GMP as well as in the European Pharmacopoeia (Ph. Eur.). A guideline with a description of QRM elements together with appropriate tools is to be found in ICH Q9, mainly directed at manufacturing. Finally implementation of QRM in the Pharmaceutical Quality System is briefly elaborated. 

An initial review of the OHSMS in place is to be made for that purpose (Section 4.1.1). Issues identified during the review are to be assessed and prioritized, and documented risk reduction objectives established for the issues selected. An ongoing review process is to be maintained for the same purposes (Section 4.1.2). 

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