Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2017 by Medicines & Healthcare Products Regulatory Agency;

Author:Medicines & Healthcare Products Regulatory Agency;
Language: eng
Format: epub
ISBN: 4860593
Publisher: Pharmaceutical Press

PHA is a tool of analysis based on applying prior experience or knowledge of a hazard or failure to identify future hazards, hazardous situations and events that might cause harm, as well as to estimate their probability of occurrence for a given activity, facility, product or system. The tool consists of: 1) the identification of the possibilities that the risk event happens, 2) the qualitative evaluation of the extent of possible injury or damage to health that could result and 3) a relative ranking of the hazard using a combination of severity and likelihood of occurrence, and 4) the identification of possible remedial measures

POTENTIAL AREAS OF USE(S)

PHA might be useful when analyzing existing systems or prioritizing hazards where circumstances prevent a more extensive technique from being used. It can be used for product, process and facility design as well as to evaluate the types of hazards for the general product type, then the product class, and finally the specific product. PHA is most commonly used early in the development of a project when there is little information on design details or operating procedures; thus, it will often be a precursor to further studies. Typically, hazards identified in the PHA are further assessed with other risk management tools such as those in this section.

I.8 Risk ranking and filtering

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