The demand for healthcare products is ever increasing as the landscape of modern society evolves. These trends are reshaping the Pharmaceutical and Biologics industries.
With the demand for products, comes the concern among pharma-bio manufacturers for regulatory scrutiny. Non-compliance is fiscally damaging and potentially life-threatening, both to a manufacturer and its customers. Warnings, fines and recalls ultimately will impact a company's bottom line, but the real risk is the potential for human harm.
Taking a proactive approach in addressing the risk of non-compliance is leading today's drug manufacturers to implement a vigorous, enterprise-wide compliance management solution that can be leveraged to enhance business processes. Organizations are seeking strategies for minimizing their exposure to risk while staying ahead of the competition in delivering safe and compliant products to the marketplace.
21 CFR Part 210-211, also known as, Current Good Manufacturing Practices (CGMP) in Manufacturing, Processing, Packing or Holding of Drugs (210); CGMP for Finished Pharmaceuticals (211): require that all drugs are compliant with the latest GMPs. The regulations ensure that drug products meet regulatory requirements as to safety, strength, quality and purity. This whitepaper shows how Pilgrim's solution can help companies comply to Part 210-211.