Develop GLP-Quality Laboratories

We work with you to help your laboratory to obtain GLP quality. The approach for each laboratory is tailor-made to the needs of the client, but usually include multiple activities, including Standard Operating Procedures (SOP) generation, staff (including Management) training, software/hardware validations, assessment of and potential addressing of needs for equipment and facilities.

We can assist with laboratory design and procedures. Clients using this service have encompassed start-ups and brand new laboratories, GMP-compliant labs moving to GLP compliance, universities, and non-GLP labs wishing to upgrade to GLP-compliant labs.

Standard Operating Procedure (SOP) preparation

We prepare standard operating procedures (SOP) for laboratory efficiency and regulatory compliance.

Since all laboratories function differently, these SOPs are prepared specifically for the operations of your laboratory.

Quality Assurance and Audits

Robin Guy Consulting performs GLP study (procedure, protocol, report and data audits) and facility audits.

We can assist your Quality Assurance Unit with Supplier and Multistudy laboratory audits. Robin Guy Consulting can also be utilized to be your Quality Assurance Unit, for GLP compliance. Robin Guy is a GLP registered Quality Assurance professional (RQAP-GLP).

Mock Inspections

We can provide a single auditor or a team to provide an FDA mock inspection. 
 
Based on our past experience and education with FDA inspections, we provide an experience similar to what you would expect during an FDA inspection.

Other GLP services include:

• Remediation services for correcting an FDA Form 483 (or FDA warning letter) fault or deficiency
• Corrective and Preventative Actions (CAPA) assistance
• Sponsor responsibility assistance
• Archives development and archival procedures
• Personnel file preparation and maintenance
• 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, including receipt, storage and use.