The Current Situation

The Pharmaceutical industry faces several major challenges in their day-to-day operations. These include mergers, changing PSM goals as well as the international nature of the industry. HAZOP’s and other PHA studies are used to ensure both a high level of safety and quality control/product integrity to ensure business continuity. The range of hazards found in the industry, however, goes far beyond the regular process industry in their complexity

Many facilities use batch operations. This means that there are continual shutdowns and start-ups leading to increased maintenance and inspections. PHA-Pro is customizable and can readily adapt to the batch nature of the industry by documenting procedural HAZOP’s and what-Ifs for the process.

The continual shutdowns and re-starts lead to increased maintenance and inspections, increasing the chance of worker injury. The further more the materials used in the processes, or in the cleaning of the machinery, can be toxic or flammable, with each bringing its own set of hazards. Job safety analysis plays a key role in reducing serious-work related injury and illnesses, which in 2001 cost US businesses $45.8 billion in 2001 up from $44.2 billion.

Product tampering is a constant threat faced by pharmaceutical companies, with the most famous being the Tylenol murders of 1982. After the events of September 11th, corporations around the world are beginning to take a more careful look at security and vulnerability concerns at their facilities. This is especially true in the pharmaceutical industry whose facilities contain hazardous or bio-hazardous material that can be used as weapons. Since 9/11, security teams conducting risk studies consider the threats posed by terrorists and other malevolent.

The Pharmaceutical industry is affected by various regulations and regulatory bodies including EPA, OSHA, FDA, GMP and cGMP. Although most pharmaceutical manufacturing facilities do not fall under OSHA 1910, they follow the same rules for best practices.

Continue >