3. Stability study reportThe report

3. Stability study reportThe report shall includeo Product / Manufacturer details: product name, product description, ingredient list, address of the manufacturing siteo An introduction with the batch used, the manufacturing date and the ‘Best Before’ dateo The parameters used for the stability study (storage conditions – temperature and RH)5 This is the responsibility of the manufacturer. The annex is only for guidance purposeso The results preferably presented in the form of a summary table, with the specification requirement (acceptance criteria) and time points for all parameters. A reference template is provided in annex II.o The details on the laboratory(ies) used, its (their) accreditation, and the test methods.o The conclusion (or the indication based on accelerated studies) based on the obtained results at30 °C/65% RH, including the justification for the shelf life and recommended storage conditions.o The stability study protocol shall be sent prior to starting the study for validation and report shall be shared when the results are available at T6 months, T12 months and then yearly until the end of the shelf life or when requested.