Chapter 6 - Safe Cosmetics and Regulatory Compliance: From Burden to Opportunity (Cosmetics as Vectors for Bioterrorists?)

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All industries whose products are chemistry based are under increased regulatory compliance requirements. Regulatory compliance is an investment, not expenditure; those that adopt and implement them successfully gain competitive advantage. Achieving the required level of data accuracy to satisfy the implied requirements of product safety regulatory compliance mandates that all reporting related to formulation development and maintenance, procurement, inventory handling, production, and QA must be accurate. Satisfying the data accuracy prerequisites lays the foundation for leveraging regulatory compliance into a competitive advantage and an increased bottom line profit. There are seven key “ingredients” that contribute to this foundation: process-batch Enterprise Resource Planning (ERP), organizing the workplace (“5S” and Lean Manufacturing), making transactional reporting easier, data security and validation, compliance integrated into work activities, visibility into the warehouse (stockroom) and factory operations, and cycle counting. Workplace organization through simple analysis techniques such as “5S” and Lean Manufacturing makes procedures simple and mistake proof, and eliminates the waste of time, movement, and money throughout the enterprise. An ERP system has a centralized and complete database on every transaction associated with a product, formula, customer, department, supplier, inventory, customer order, purchase order, work-cell, schedule, batch, QA, cost, and financial ledgers. By placing personal computers networked to the process-batch ERP system using a user interface familiar to the workforce in a location easy to access by authorized personnel. Access to the ERP system is controlled through a role that each system user has assigned to them and Dual Electronic Signatures (DES). Process-batch ERP has predesigned “windows” that provide the authorized visibility needed to take prompt corrective action. Cycle counting is an important contributor to data accuracy and leveraging regulatory compliance into a competitive advantage. Concerns centered on bioterrorism have driven the many new regulatory compliance requirements.