No. However, the results from these studies are required to be reliable and meaningful. For that reason, other certificates may be used in lieu of a GMP certification, such as a current Good Laboratory Practice (GLP) certificate or licence issued by a REGULATORY AUTHORITY acceptable to the TGA or a current ISO 17025 accreditation certificate. Stability test methods used by the laboratory should be appropriately validated and documented ACCORDING to the requirements of the Code.

The results from the on-going stability monitoring studies must be considered as PART of release for supply, which is the final step in manufacturing.

No. However, the results from these studies are required to be reliable and meaningful. For that reason, other certificates may be used in lieu of a GMP certification, such as a current Good Laboratory Practice (GLP) certificate or licence issued by a regulatory authority acceptable to the TGA or a current ISO 17025 accreditation certificate. Stability test methods used by the laboratory should be appropriately validated and documented according to the requirements of the Code.

The results from the on-going stability monitoring studies must be considered as part of release for supply, which is the final step in manufacturing.