Good Laboratory Practices (GLP) consulting is another specialty at Robin Guy Consulting, LLC. We assist laboratory management and personnel in getting their laboratories up to GLP standards.

For a laboratory to be considered part of a GLP study, the laboratory needs to be up to GLP standards. We are able to assist laboratories in becoming GLP compliant.  We currently see many GMP, analytical, university and small laboratories that want to make the move to become GLP compliant. This process takes time, resources and a lot of commitment from personnel and management.  AAALAC certification of animal facilities or ISO and CLIA for analytical, bioanalytical, clinical pathology and forensic laboratories are not enough to be considered GLP compliant. 

The following GLP consulting services are offered by Robin Guy Consulting, and follow FDA, EPA and OECD GLP regulations:

• Assist with upgrading laboratories to be up to GLP standards. A gap-analysis or a mock inspection may be the first step to determine GLP deficiencies.
• Preparation of standard operating procedures (SOP) for laboratory efficiency and regulatory compliance.
• GLP audits include:
  • Facility audits
  • Study audits
  • Archive audits
  • Procedural audits
  • Mock inspections
  • Report and protocol audit
  • Document review
• Assistance with a variety of other GLP functions and processes, including:
  • Archives
  • Personnel files
  • Quality Assurance consulting services
  • Training procedures and documentation
  • Facility issues (lighting, HVAC, water supply, pest control, etc.)
  • Equipment considerations, validation and documentation
  • Protocol, forms and report formats, contents and preparation
  • Test and Control article/item/substance considerations.
• GLP training for a variety of personnel and laboratories (see Training Division page)

Robin Guy is a GLP certified professional (RQAP-GLP) (see Background page).