Sanger Sequencing in Compliance with Good Laboratory Practice (GLP)
In addition to the services described above, the following components are included when sequencing is performed under GLP:
- Preparation of Study Plan incl. description of materials and methods (incl. one revision after sponsor´s review)
- Evaluation and documentation of sequencing results.
- Provision of an overview table (embedded in the Study Report, if feasible) where possible sequence variations are listed
- Preparation of Study Report incl. GLP compliance statement (incl. one revision after sponsor´s review)
- Study Inspection by QA and Quality Assurance Statement
- Archiving the study data / documentation for 15 years
To ensure the quality of our GLP sequencing service, we are routinely assessed by first and second external auditors. Additionally, we perform regularly facility and process audits.
References:
Sequencing is performed according to standard methods and in compliance with
CLSI Guideline MM09-A; Vol. 34 No. 4, 2014; Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine, Approved Guideline-Second Edition
Conduct of sequencing studies is performed according to
OECD Guideline ENV/MC/CHEM(98)17 (rev.1999): The Principles of Good Laboratory Praxis (Monograph No. 01) and OECD Guideline ENV/JM/MONO(1999)23 (rev. 2002): Short Term Study and GLP (Monograph No. 07)
Quality assurance (QA) activities related to sequencing studies (review of the study plan, inspection of study, study report and raw data) are conducted according to
OECD Guideline ENV/JM/MONO (1999) 20 (03-October-2002): Quality Assurance and GLP