GLP Test Facility Selection Guide for Bio Companies
Selecting the right GLP (Good Laboratory Practice) test facility is a critical decision in the drug development process. GLP studies provide the safety data that regulatory authorities rely upon when evaluating new drug applications. A poor facility choice can result in study failures, regulatory delays, and wasted resources. This guide helps bio companies make informed facility selection decisions.
GLP Overview
Good Laboratory Practice principles: GLP is a quality system governing the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reportedRegulatory significance: GLP compliance is required by MFDS, FDA, EMA, and other regulatory authorities worldwide. Studies conducted at non-GLP facilities are generally not accepted for regulatory submissionsStudy types covered: GLP applies to single-dose and repeat-dose toxicology, genotoxicity, carcinogenicity, reproductive and developmental toxicology, pharmacokinetics (ADME), and safety pharmacology studiesInternational mutual acceptance: Korea participates in the OECD Mutual Acceptance of Data (MAD) program, meaning GLP studies conducted at Korean-accredited facilities are accepted by regulatory authorities in other OECD member countriesKey Evaluation Criteria
When evaluating potential GLP test facilities, consider these essential criteria:
Accreditation status: Verify current GLP accreditation from the relevant national authority (MFDS for Korea) and confirm the scope of accreditation covers your required study types and test speciesSpecies capability: Ensure the facility has experience with your required test species (rodent, non-rodent, or non-human primate) and maintains adequate animal housing and husbandry standardsStudy types: Confirm the facility has demonstrated capability in conducting the specific study types you need, with verifiable track records and relevant experienceStaff expertise: Evaluate the qualifications and experience of study directors, principal investigators, and key technical staff, including their familiarity with your product typeCapacity and timeline: Assess the facility's current workload and ability to accommodate your study within your required timelineSite Visit Checklist
A pre-study site visit is strongly recommended before committing to any GLP facility. Key areas to evaluate include:
Facility condition: Assess the cleanliness, maintenance, and organization of animal rooms, laboratories, and support areas. Well-maintained facilities reflect overall quality cultureQA system: Review the Quality Assurance unit's independence, staffing, inspection schedules, and track record. A robust QA system is the backbone of GLP complianceStudy director qualifications: Meet the proposed study director to assess their experience with similar studies, communication style, and availability throughout your studyData management: Evaluate the facility's data capture systems, raw data handling procedures, and archive facilities. Increasingly, electronic data capture systems with audit trails are expectedAnimal welfare: Observe animal care practices, veterinary oversight, and environmental monitoring. High standards of animal welfare are both ethically important and critical for data qualityRegulatory history: Inquire about recent inspection findings from MFDS or other regulatory authorities and how any deficiencies were resolvedCost Considerations
Study pricing: GLP study costs vary significantly based on study type, species, group size, and duration. Obtain detailed quotations including all ancillary costsHidden costs: Be aware of potential additional charges for protocol amendments, unscheduled analyses, extended observation periods, or additional histopathology evaluationsValue vs. price: The cheapest facility is rarely the best choice. Consider the total cost of potential study delays, regulatory rejections, or required repeat studies when evaluating pricingPayment terms: Negotiate payment milestones tied to study progress rather than large upfront payments, preserving cash flow flexibilityBudget for contingencies: Allocate a contingency budget of 10-15% above the quoted study cost to accommodate unforeseen protocol modifications or additional analysesCommon Mistakes in Facility Selection
Avoid these three critical pitfalls when choosing a GLP test facility:
Selecting based on price alone: Choosing the lowest-cost provider without adequate evaluation of quality systems, expertise, and track record often leads to study failures, regulatory queries, and ultimately higher total costs from repeat studiesInadequate due diligence: Skipping the site visit or relying solely on the facility's marketing materials rather than conducting thorough firsthand evaluation of capabilities, systems, and personnelIgnoring communication capabilities: Failing to assess the facility's communication responsiveness and reporting quality. Timely, clear communication throughout the study is essential for identifying and resolving issues before they compromise study integrityHow KITIM Can Help
KITIM assists bio companies with GLP facility evaluation, selection, and study monitoring. Our consultants conduct independent facility assessments, help develop study protocols, and provide oversight throughout the study process. Contact us to ensure your preclinical studies are conducted at facilities that meet the highest standards.
