top of page
FDA cGMP (current Good Manufacturing Practice) 

Provision Consulting Group will work within your organization to create and develop your cGMP (current Good Manufacturing Practice) processes. Our deep knowledge and experience help companies improve features, reduce costs, and increase quality--all done within compliance to keep the FDA satisfied.

Our experience and understanding of the FDA allow us to successfully develop appropriate responses to compliance issues and implement comprehensive strategies that help move the client forward. Clients can count on our ability to build and restructure a strong and productive internal organization while leveraging our successful experiences in dealing with the FDA. The FDA 21 CFR (Code of Federal Regulation) part 820, 210 and 211 demands a structured system to make sure that the quality of a product remains faithful to its indications for us, consistent, and safe. There are ISO 9001, ISO 22716, and ISO 13485, but they may not be enough to meet the requirements of the FDA. Moreover, a product's unique characteristics may need to be addressed in a manner that is acceptable to the FDA. 

PCG's FDA cGMP Consulting Services:
  • On-Site Mock Audit for CFR 820, CFR 210, CFR 211, MoCRA 

  • Draft SOP

  • SOP Implementation

  • Training

  • Management

  • Representative Role Upon Audit

  • Personnel Qualification and Staffing

  • Investigations

  • CAPA

  • Document Management

  • Electronic Quality Management Systems

  • Process Validation

  • Cleaning Validation

  • Equipment Qualification and Validation

  • Manufacturing Batch Records

  • Packaging Batch Records

  • Part 11 Compliance

  • Laboratory Controls

  • Analytical Method Validation

  • Supplier Qualification Program

  • Internal Audit Program

  • Raw Material Testing and Controls

  • Environmental Monitoring

  • Inventory Management

  • 483 Obsevations

  • Warning Letter Response

  • Recalls and Corrections

  • Regulatory Liaison During FDA Audit

bottom of page