Hi,

Two links for OECD and FDA GLP standards should be useful at preparation stage.

OECD

https://www.oecd.org/chemicalsafety/testing/good-laboratory-practiceglp.htm#:~:text=The%20OECD%20Principles%20of%20Good,Acceptance%20of%20Data%20(MAD).

FDA

https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/good-laboratory-practice-nonclinical-laboratory-studies

Another group of regulations (good to be familiar with the content) are:

EMA (2016) Guideline on non-clinical local tolerance testing of medicinal products. EMA/CHMP/SWP/2145/2000 Rev. 1, Corr. 1*, 1-9.

FDA (2003) Exposure-Response Relationships – Study Design, Data Analysis, and Regulatory Applications. 1-28

ICH (1994) Topic E 4 Dose Response Information to Support Drug Registration CPMP/ICH/378/95, 1-10.

ICH (2010) Guidance For Industry M3(R2) Nonclinical Safety Studies For The Conduct Of Human Clinical Trials And Marketing Authorization For Pharmaceuticals.

ICH (2012) Guideline S6 (R1) – Preclinical Safety Evaluation Of Biotechnology-Derived Pharmaceuticals.

ICH (2009) ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals. EMA/CPMP/ICH/286/1995, 1-26.

P. Haley, R. Perry, D. Ennulat, S. Frame, C. Johnson, J.-M. Lapointe, A. Nyska, P.W. Snyder, D. Walker, and G. Walter (2005). STP Position Paper: Best Practice Guideline for the Routine Pathology Evaluation of the Immune System. Toxicol Pathol 2005 33: 404-407.

EMA (2012) Guideline on bioanalytical method validation EMEA/CHMP/EWP/192217/2009, 1-22.

FDA (2013) Bioanalytical Method Validation.1-34.

WHO (2002) Use of anticoagulants in diagnostic laboratory investigations. & Stability of blood, plasma and serum samples. WHO/DIL/LAB/99.1 Rev.2., 1-64

EC (2006) Appendix A Of The European Convention For The Protection Of Vertebrate Animals Used For Experimental And Other Scientific Purposes (ETS NO. 123) Guidelines For Accommodation And Care Of Animals (article 5 of the convention) approved by the multilateral consultation.

EC (2010) DIRECTIVE 2010/63/EU of The European Parliament And Of The Council On The Protection Of Animals Used For Scientific Purposes Text With EEA Relevance.

EC (2012) Commission implementing decision of 14 November 2012 establishing a common format for the submission of the information pursuant to directive 2010/63/EU of the European Parliament and of the council on the protection of animals used for scientific purposes (notified under document C(2012) 8064) (text with EEA relevance) (2012/707/EU)

FDA (2009) Guidance For Industry Animal Models - Essential Elements To Address Efficacy Under The Animal Rule.

FDA (2003) guidance for industry source animal, product, preclinical, and clinical issues concerning the use of xenotransplantation products in humans.

Please note that some regulations are updated. This panel present only some range of activities. Not all dependent on profile of the lab will be applicable. I'm not sure you need GMP for preclinical testing but its depends on lab profile (in case of DP/DS stability testing GMP is expected). Moreover different countries apply for different roles but best way is be in line with ICH interpretation (generally "highly regulated" markets).

Key steps in GLP lab setup cover:

1. Establish a GLP Quality Assurance Program

2. Appoint a Study Director responsible for overall GLP compliance

3. Implement a Quality Assurance Unit (QAU) that is independent of the testing facility

4. Develop Standard Operating Procedures (SOPs) covering all aspects of the lab operations

5. Ensure Proper Facilities and Equipment

6. Provide separate areas for different activities to prevent interference and disturbances

7. Implement a program for qualification, calibration, and maintenance of all equipment

8. Characterize Test Items and Test Systems

9. Thoroughly document and characterize the test and reference items used in studies

10. Carefully select and document the test systems (e.g. animal models, cell lines)

11. Establish Robust Study Plans and Procedures

12. Develop detailed study protocols and SOPs for conducting studies

13. Ensure raw data, final reports, and archives are properly maintained

14. Hire and Train Qualified Personnel

15. Ensure staff have the necessary qualifications and training for their roles

16. Provide ongoing training to maintain GLP compliance

17. Leverage External Expertise and Resources

18. Consider hiring GLP consultants to help establish the facility and processes

19. Utilize pre-validated protocols and equipment qualification procedures

Hope it helps,

Best regards

Tomasz