Validation of Puritan's Water System to USP Standards is Key to our Future

Puritan Products believes that a significant component of our company's growth will be linked to the pharmaceutical and biotechnology markets. In support of that belief, the company is undertaking various improvements and changes that will make us cGMP compliant. cGMPs, or current good manufacturing processes, are the foundation of the FDA-monitored quality system that protects consumers as well as the "gold standard" of the global pharm/bio industries.

One of the ways to achieve this important goal is by validating our water system to the USP (United States Pharmacopoeia) standard. Validation, in this industry, is the scientific process used to generate empirical evidence that a system is designed appropriately, operates correctly and consistently produces product that meets the expected quality standard. To achieve that validation, Puritan is modifying our physical system to ensure that 1) it can be maintained in a sanitary state and 2) no areas exist where the water quality is allowed to change.

Puritan Products is investing in acquiring the expertise and systems to meet these stringent requirements. We have engaged the appropriate industry experts to help us, and we will train our employees to meet the challenges that will make our company a strategic supplier to the pharmaceutical and biotechnology industries.

Why is this validation process necessary and what value does it add to our company? According to Matt Walczer, Director of Sales and Business Development, the answer is, quite simply, to eliminate any doubt! "Once our water system has been validated, consumers of products made with water from that system will have a high degree of confidence that this water will not present a problem or complication. Consumers, in turn, are confident that products made under cGMP guidelines will truly represent the information on the label," adds Matt.