FDA required CRC’s consultation and independent analysis of the cleanroom’s performance. CRC provided a third-party analysis of the cleanroom’s operations and results of Testing and Air Balance. Repairs were required to the cleanroom and CRC provided recommendations to upgrade the cleanroom and indicated the minimum repairs required to have the cleanroom remain in compliance with the following guidelines and regulations:

  • 21 Code of Federal Regulations (CFR) Part 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs
  • 21 Code of Federal Regulations (CFR) Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP)