Manufacturing, cGMPs Improvement and Compliance

 

An effective cGMP program is important for meeting regulatory agency compliance requirements. We will support your existing operations by identifying issues within the manufacturing operations with respect to proper documentation of activities, good record keeping, manufacturing/shop floor compliance and compliance with internal standard operating procedures(SOPs) We can also support your documentation development such as  SOP writing, SOP review and improvements, manufacturing batch record review, validation protocol writing and supporting GMP documentation and production records development. 

 

 

Our services at a glance:

  • Manufacturing & Shop Floor Compliance
  • Remediation & Resolution Support for FDA Regulated Industries
  • Investigations/CAPA Management & Support
  • Documentation Support(SOPs, Batch Record Reviews, Equipment Logs, Room Logs, Training Logs, Cleaning Logs)
  • Other Production Records/Documentation Development Support