specify the formulations used in the and state which batches are identical to those proposed • for registration in Australia; state whether the batches used in the study were laboratory, pilot or production batches; • specify the size of each batch (eg. 50 kg) • clearly describe the packaging used in the and confirm whether it is identical to the pack • which will be used in Australia; present stability data on at least two batches of the product; • specify the temperature, lighting and humidity conditions applied during the study; • describe all test methods and sample sizes; • provide validation of analytical methods (and include copies of relevant chromatograms); • provide quantitative results where possible (in preference to test” or similar wording); • “passes where possible, include quantitative or semi-quantitative determinations of the content of • degradation products do not use an HPLC procedure to detect impurities without validation for this purpose. • HPLC assay procedures as used for determination of the active ingredient may be unsuitable for separation and detection of impurities if they use too short a run time. Such a procedure would be acceptable if validated for impurity detection (note, however, that long run times do not in themselves ensure good separation); comment or conduct additional where there is a lack of balance between the formation of • degradation products and the loss of the active substance. For example, are the assay procedures sufficiently specific? Is the active ingredient volatile? Is it adsorbed onto the container wall? consider additional tests to investigate the significance of obvious alterations in the • characteristics of the product (eg. a distinct change in the colour of the product may necessitate additional investigation for degradation products); include relevant information on the physical characteristics of the product during storage, such • as dissolution characteristics, homogeneity, particle size etc; include stability studies conditions of high humidity for products which are to be registered • in moisture-permeable containers, and especially for those which are potentially labile to moisture; provide results from sufficient time stations to allow assessment of any trends in the • parameters; provide results for individual dosage where these are available (eg. dissolution profiles). •
• specify the formulations used in the and state which batches are identical to those proposed for registration in Australia; • state whether the batches used in the study were laboratory, pilot or production batches; • specify the size of each batch (eg. 50 kg) • clearly describe the packaging used in the and confirm whether it is identical to the pack which will be used in Australia; • present stability data on at least two batches of the product; • specify the temperature, lighting and humidity conditions applied during the study; • describe all test methods and sample sizes; • provide validation of analytical methods (and include copies of relevant chromatograms); • provide quantitative results where possible (in preference to “passes test” or similar wording); • where possible, include quantitative or semi-quantitative determinations of the content of degradation products • do not use an HPLC procedure to detect impurities without validation for this purpose. HPLC assay procedures as used for determination of the active ingredient may be unsuitable for separation and detection of impurities if they use too short a run time. Such a procedure would be acceptable if validated for impurity detection (note, however, that long run times do not in themselves ensure good separation); • comment or conduct additional where there is a lack of balance between the formation of degradation products and the loss of the active substance. For example, are the assay procedures sufficiently specific? Is the active ingredient volatile? Is it adsorbed onto the container wall? • consider additional tests to investigate the significance of obvious alterations in the characteristics of the product (eg. a distinct change in the colour of the product may necessitate additional investigation for degradation products); • include relevant information on the physical characteristics of the product during storage, such as dissolution characteristics, homogeneity, particle size etc; • include stability studies conditions of high humidity for products which are to be registered in moisture-permeable containers, and especially for those which are potentially labile to moisture; • provide results from sufficient time stations to allow assessment of any trends in the parameters; • provide results for individual dosage where these are available (eg. dissolution profiles).
otc-argom-121011.docx