GMP Quality Services

Beaufort offers comprehensive services in a broad range of GMP disciplines, including quality assurance, quality control, validation and verification, training, auditing and preparation of CMC regulatory submission sections. Our team of quality assurance professionals deploys proven operational principles and maintains a strict independent and unbiased approach that is specifically designed to help ensure the integrity and compliance of your efforts. These methods ultimately help prevent defects in the manufacturing process, including packaging and labeling, that can put the quality of your product in jeopardy.

Beaufort’s highly skilled experts will either coach or actively serve on your team to ensure policy and procedures are in place. We can help your team identify and resolve production/process complications or tailor an entire program to drive effective, efficient manufacturing protocols.

From your manufacturing environment(s), to the people and processes operating within them, trust Beaufort for technical, analytical and regulatory guidance.

Production and Process Controls

Beaufort plans, designs, implements and executes comprehensive product and process control methodologies.

  • Process validation and verification support
  • Corrective and preventive action (CAPA)
  • Root cause analysis
  • Operational excellence/Six Sigma
  • Continuous improvement and business process improvement

 

Validation and Verification

Beaufort will help you establish the quality and control of the processes and infrastructure your product needs to be manufactured safely and effectively.

  • Process validation and verification
  • Equipment validations
  • Analytic validations
  • Installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) and product validations
  • Software validations

 

Complaint Management

Our team will ensure the quality of your product stays consistent, handling every facet of complaints, and when necessary, investigation and CAPA procedures.

  • Complaint handling SOP development
  • Regulatory reporting requirements
  • Customer complaint documentation
  • Conducting customer complaint investigations
  • Safety/pharmacovigilance/post-market surveillance
  • Tracking and trending

 

Auditing Services

Beaufort’s GMP professionals have extensive experience auditing across all process disciplines and involving multiple regulatory authorities.

  • Design control procedures
  • Risk management programs
  • Input/output and design transfer