The quality assurance program of Iris Pharma ensures that studies are performed in complete compliance with GLP. Regular audits are carried out for each GLP study (including protocols, in-life phases, raw data and reports), for different laboratory processes (including management of test substances, animals, documentation, materials, waste, archives and samples) and for internal technical training.

SOPs

Each activity follows internal Standard Operating Procedures (SOPs).

The broad topics are as follows:

• Generals activities (including staff, management of files, raw data and archiving)
• Animals (including husbandry, maintenance, alimentation, environmental parameters, identification and documentation)
• Bio-analysis (including validation, stability and assay in studies)
• Histology (including fixation, inclusion, cutting, coloration and reading)
• Animal experimentation (including anesthesia, administration, inflammation models, allergy, ROP, IOP, CNV)
• Supplies (including management, documentation, storage, identification and handling)
• Equipment (including management, identification, documentation and calibration)
• Sampling (including identification, procedure for each type of sample -eyes, other organs and blood)
• Quality assurance (including audits, management of non-conformity and SOPs)
• Laboratory safety

SOPs are regularly reviewed and updated. The training on SOPs is recorded for each member of staff.

STAFF

Regular training sessions and meetings enable the review of the principles of GLP and deviations from them. All training sessions are recorded and reviewed by the technician responsible for validation.

EQUIPMENT

All equipment is identified and is regularly maintained. Each piece of equipment involved in GLP studies is qualified QI QO QP (including animal husbandry software, LCMS, histology apparatus, hemato-biochemistry apparatus and radiodetection apparatus). Balances and micropipettes are calibrated regularly.

ANIMAL HUSBANDRY

A centralized program (GTC) controls all environmental parameters. The parameters follow the recommended guidelines. Animals are obtained from certified breeding centers and are checked daily. Only controlled food is distributed to animals and water analysis (bacteriology) is carried out each month.

TEST SUBSTANCES

Traceability of test substances is of paramount importance. In accordance with GLP, the location of test substances is fully recorded from the time of their arrival to their use or destruction. We can store your product at room temperature, in a refrigerator, in a freezer, at -80°C, protected from light, protected from moisture, etc.
GLP requirements for test substances are described in this document.

ARCHIVING

Study protocols, amendments, raw data, biological specimens (where applicable), any correspondence and copies of final reports are stored for a period of 5 years from the date of the final report, either at a document storage specialist for GLP studies or in Iris Pharma's archives for non-GLP studies. At the end of this period the Sponsor is contacted to decide by joint agreement, on continued storage, submission to the Sponsor or destruction of records.