Pharmaceutical manufacturing begins with a variety of raw materials, which may be organic, chemical or synthetic, that are then combined, mixed, and blended in proper proportions to produce an end product. Some may need to be heated in the process; others will not. The end product may be cream, jelly, powdered, capsules, liquid, or suppository, to name a few. Each process is different and has different characteristics, but the primary concerns are cleanliness, purity, and the proper mix of ingredients.

Property exposure depends upon the raw materials and ingredients. Because many of the mixing operations are automated, a machinery exposure exists. Machines must be cleaned and maintained on a regular basis. Flammables must be separated and properly stored in adequate approved containers. Damageability of the product is a major concern. Due to sterile conditions any fire can result in a total loss. Separation of the final product from the processing operation can prevent the total loss potential.

Occupiers’ Liability is normally low to moderate. Access to visitors is usually limited and controlled, due to the need for cleanliness.

Products liability is very high and, again, purity, cleanliness, and proper mixture of ingredients is critical. Any exposure to contaminants could result in severe losses. Quality control is of the utmost concern, as is compliance with all government regulations and controls.

Environmental impairment is also very high, and every aspect of air, noise, water and waste treatment must be reviewed and evaluated.

Automobile exposure is very high, if the manufacturer has its own tanker trucks for pickup of raw materials and does its own transport. The drivers should have Haz Mat licences and their driving records should be checked on a regular basis. Of equal importance is the condition and maintenance of the vehicles, especially tankers. All maintenance must be documented.

Workers compensation exposure is machinery-related, so safety, training and guarding are important items to evaluate. So, too, are the chemical exposures that result in skin and eye irritations, as well as respiratory problems. Workers must be made aware of the potential side effects of the chemicals they work with in order to assess any symptoms they may have.

Minimum recommended coverage:

Building, Business Personal Property, Business Income, Accounts Receivable, Computers, Goods in Transit, Employee Dishonesty, General Liability, Employee Benefits, Environmental Impairment, Umbrella, Hired and Non-owned Auto, Workers Compensation

Other coverages to consider:

Business Auto Liability and Physical Damage, Employment Practises Liability

Contact KRG Insurance for our pharmaceutical insurance program today!