Manufacturing/cGMPs

UL's current good manufacturing practices (cGMP) solutions assist pharmaceutical companies to assure the quality of finished pharmaceuticals, active pharmaceutical ingredients (APIs) and excipients. Our manufacturing solutions streamline the compliance learning program by identifying knowledge gaps and targeting training where needed by employees, subcontractors and suppliers. Learner competency is tested, reinforced and documented in defensible records of all training activities. Client-specific certification programs confirm employee and subcontractor qualifications to perform tasks.

UL’s technologies are used by the FDA and non-US regulatory agencies to train inspectors around the world. Available in 30 languages, UL’s Manufacturing/cGMP solution is deployed around the world by many of the top multi-national pharmaceutical companies. We have worked with brand owners, generic manufacturers, contract manufacturing organizations (CMOs), API manufacturers and packaging companies to meet needs including:

  • SOP development, updates, distribution and training;
  • SOP and critical documents management;
  • Compliance programs responsive to FDA’s risk-based approach;
  • GMP compliance with international regulations and standards from organizations including the European Medicines Agency, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), the International Committee on Harmonization (ICH) and Australia’s Therapeutic Goods Administration (TGA);
  • Employee training, testing, and qualification for job functions;
  • Training for inspections/audits;
  • Extension of training to subcontractors, vendors, wholesalers, suppliers and distributors;
  • Documentation for Corrective and Preventive Action Plans.

Global Regulatory Compliance Learning

Addressing International Regulatory and Corporate Compliance Requirements