Processing Responsibility in Bulk Drug Process Development

PROCESSING RESPONSIBILITY IN BULK DRUG PROCESS DEVELOPMENT 

All chemical processing, whether on a large or a small scale, whether for high value chemicals or commodities, or for bulk drugs, textile polymers, petrochemicals or household products, carries a risk to those that work in the industry, to people around the manufacturing sites and beyond, and to the environment locally, beyond the locality, and at large. Indeed, the risk comes about from multiple directions  

The hazards created by the chemistry itself (a) intended and unintended energy releases, and (b) the various hazards of handling the materials involved. Bulk drugs often 

The specific manner in which the chemical processes is implemented at scale. Most risks in chemical processing are a function of the process design, the equipment design, and the operating procedures used to manufacture the products. In other words, the same inherent hazard can he implemented at various levels of risk depending on the specifics of implementation, and often enough details matter. 

Hazard—a source of danger, of possible injury or loss. Risk—The probability of suffering a given loss or injury from a hazard. 

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VI. PROCESSING RESPONSIBILITY IN BULK DRUG PROCESS DEVELOPMENT... 

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