Quality Assurance Consultancy has established and implemented more than 100 Good
Laboratory Practice (GLP) programs for a mix of clients that include the following:
- Research and discovery units required to conduct specific regulatory studies
- Existing contract research organizations (CROs) and start-up companies preparing to
conduct regulatory studies
- Sponsor laboratories requiring an individual GLP structure
- University laboratories needing to develop GLP capabilities
- Government laboratories needing to develop GLP capabilities
Our comprehensive solutions and team of specialists support these organizations by
helping them:
- Perform gap analysis of an existing quality system
- Develop an implementation plan with management personnel
- Develop a quality assurance unit (QAU)
- Develop and customize a standard operating procedure (SOP)
- Harmonize SOPs with other quality systems, such as the International Organization for Standardization (ISO), Organisation for Economic Co-operation and Development (OECD) and Good Manufacturing Practice (GMP)
- Conduct GLP training of all study personnel
- Develop customized documentation forms
- Assist management and the QAU during implementation
- Assist clients during regulatory GLP inspection
- FM-200™ fire suppression system
- Vesda ® early-warning fire detection system that analyzes air for smoke particles
- Security system with 24-hour monitoring
- Room temperature archiving for:
- Documents and electronic media
- Test/control/reference substances/articles
- Wet-tissue specimens
- Paraffin-embedded blocks
- Microscopic slides
- Retention of samples
- -20 ºC freezer archiving
- 1 to 8 ºC refrigerator archiving
- Temperature and humidity-controlled environment to prevent deterioration
- Limited and controlled access
- In-house developed archive database for prompt retrieval
