Assess and strengthen Good Manufacturing Practices.

Good Manufacturing Practices ensure products are produced and controlled to the appropriate quality standards while adhering to industry regulations. Resolving and preventing compliance issues for medical products requires expertise in planning, developing, and implementing Good Manufacturing Practice (GMP) quality systems.

How we can help

Our quality professionals bring direct experience in pharmaceutical, biotechnology, combination, and medical device development and manufacturing to help you understand and address quality assurance needs at every stage of product development.

Our team works closely with your staff to improve processes for manufacturing, distribution, and packaging facilities.

Our quality professionals take the lead in planning, executing, and analyzing comprehensive audits to uncover potential deficiencies and make the necessary improvements, all while empowering your staff to maintain compliance well into the future.

Our GMP auditing services include:

  • Mock Pre-Approval Inspections (PAI) and mock FDA audits
  • Mock Notified Body Inspections
  • Vendor/supplier audits
  • MDSAP audits
  • Formal risk assessments & risk mitigation strategies
  • Quality system & corporate SOP gap analysis

Additionally, we assist clients in:

  • Compliance master planning and strategy
  • Corrective actions and implementation plans
  • Planning and execution of remediation projects
  • Validation and qualification
  • Quality system & corporate SOP guidance and development
  • Training and development of training programs

Contact The FDA Group today for a GMP audit consultation.