Quality Assurance Consultancy has established and implemented over 100 Good Laboratory Practices (GLP) programs.

Projects include:

  • 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 and GLP archiving requirements
  • University laboratories needing to develop GLP capabilities and GLP refrigerator/freezer archiving
  • Government laboratories needing to develop GLP capabilities

Tasks include:

  • Perform gap analysis of existing quality system
  • Develop an implementation plan with management
  • Develop bioanalytical quality assurance (QA)
  • Develop and customize an entire standard operating standards SOP manual
  • Harmonize SOPs with other Quality Systems (ISO, OECD, GMP)
  • Conduct GLP training of all study personnel
  • Develop customized documentation forms
  • Assist management and quality assurance unit (QAU) during the implementation
  • Assist client during Regulatory GLP inspection
Case Study