Quality Systems

Quality Assurance

• A designated Quality Assurance Programme exists at Intox, following the OECD Guidance document.
• Our independent Quality Assurance Unit consists of a team of ten experts from diverse fields, including Toxicology, Chemistry, DMPK, Biotechnology, and Environmental Science.
• QA team members have prior technical experience and extensive knowledge of the subjects they audit.
• QA auditors undergo exhaustive GLP training conducted by regulatory authorities, external trainers, and in-house experts.

Functions of the Quality Assurance Unit (QAU)

1Study-Based Inspections

• Review of draft and final study plans.
• Inspection of critical in-life phases.
• Evaluation of draft and final reports.

2Facility-Based Inspections

• Regular audits of processes and facilities.
• Master schedule audits.
• SOP/Format audits.
• Specimen audits before archiving.
• Audit of contract testing laboratories.

3Additional QAU Responsibilities

• Reporting inspection findings to Test Facility Management and Study Directors or concerned personnel.
• Providing GLP regulations training and refresher courses to staff, including new entrants to the QAU.
• Participating in meetings with sponsors, regulatory authorities, and GLP monitoring authorities.

In-house Audits

• Comprehensive audits of studies, including study plans, experiments, raw data, and study reports.
• Regular audits of processes and facilities to ensure ongoing compliance and quality.

Site and Vendor Audits

Conducting audits and pre-placement assessments of facilities at third-party Contract Research Organizations.

Trainings

• Offering GLP training on various topics, including basic and refresher courses.
• Providing interpretation of GLP principles.
• Tailored job-specific training.
• Conducting compliance case studies.
• Promoting a quality-by-design approach.

Standard Operating Procedures

• Preparation and revision of standard operating procedures to ensure they meet GLP standards.
• Reviewing SOPs for GLP conformity to maintain high-quality standards.

Validation of Computerised Systems

Establishing validation standards and performing thorough validation processes for computerized systems to ensure accuracy and reliability.