ESSEM Compliances Solutions Private Limited has independent QA unit with well qualified and competent auditor, functioning with internal Standard Operating Procedures based on the principles of OECD GLP. The studies carried out at ESSEM will be audited by QAU for ensuring the integrity, quality and GLP Principles.
The QAU inspectors execute following three different types of audits as per the OECD GLP Principles:
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Study-based Inspections
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Facility-based Inspections
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Process based Inspections
The archivist is responsible for the management, operations and procedures for archiving in accordance with established Standard Operating Procedures, and the Principles of GLP.
- ensure that access to the archive is controlled;
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ensure that the orderly storage and retrieval of records and materials is facilitated by a system of indexing; and
- ensure that movement of records and materials in and out of the archives is properly controlled and documented
TICO primarily involve in safe receipt of the test item, providing the unique code, accountability of usage, documentation, and maintaining the Test Item and reference substance in environmentally controlled storage till usage, and disposal
DCO maintain, control the distribution of documents in the test facility and ensure the data integrity adhering to OECD principles of GLP
