Robin Guy Consulting is known internationally for Good Laboratory Practice (GLP) Consulting and Quality Assurance services.
Laboratory professionals worldwide attend our GLP training courses.
Develop GLP-Quality Laboratories
We are able to assist laboratories in becoming GLP compliant.
We work with you to help your laboratory to become GLP compliant, or more compliant. 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).
GLP audits include:
- Facility audits
- Study audits
- Archive audits
- Procedural audits
- Mock inspections
- Report and protocol audit
- Document review
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
- 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.
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GLP Training Division