QFB Analytical method which has been demonstrated to maintain or O - – improve analytical performance (accuracy, precision and/or specificity) QFC Analytical method other than as specified above in change A - – QFB QFS Expiry specification ranges following changes to the BP, PH Eur, O - USP or the General standard for tablets and capsules Quality control changes starting material specifications Status A/D* – QSX Range more restrictive O - – QSE Range less restrictive A - – QST Addition of an extra test O - QSU Deletion of an existing test A - QSA Analytical method to comply with amendments to a standard O - – (e.g. the BP, PH Eur, USP or a TGO) QSB Analytical method which has been demonstrated to maintain O - – or improve analytical performance (accuracy, precision and/or specificity) QSC Analytical method other than as specified above in change A - – QSB QSM Manufacturer of starting material (specifications unchanged) O - QSS Supplier of starting material O - Status A/D* Packaging changes KCT Container type (as defined in TGA Standard Terminology) NEW - KBT Container material if the container is a bottle, the goods are a N 5, 10, 13, – solid dosage form (e.g. tablet) and the change is of a type listed 15 & 16 in assurance 15 Container material to coloured glass O - KGL –
QFB Analytical method – which has been demonstrated to maintain or improve analytical performance (accuracy, precision and/or specificity) O - QFC Analytical method – other than as specified above in change QFB A - QFS Expiry specification ranges following changes to the BP, PH Eur, USP or the General standard for tablets and capsules O - Quality control changes – starting material specifications Status A/D* QSX Range – more restrictive O - QSE Range – less restrictive A - QST Addition of an extra test O - QSU Deletion of an existing test A - QSA Analytical method – to comply with amendments to a standard (e.g. the BP, PH Eur, USP or a TGO) O - QSB Analytical method – which has been demonstrated to maintain or improve analytical performance (accuracy, precision and/or specificity) O - QSC Analytical method – other than as specified above in change QSB A - QSM Manufacturer of starting material (specifications unchanged) O - QSS Supplier of starting material O - Packaging changes Status A/D* KCT Container type (as defined in TGA Standard Terminology) NEW - KBT Container material – if the container is a bottle, the goods are a solid dosage form (e.g. tablet) and the change is of a type listed in assurance 15 N 5, 10, 13, 15 & 16 KGL Container material – to coloured glass O -
cm-argcm-p1-110825.docx