Packaging, Labeling and Storage. Centrally supplied alendronate will not be repackaged for the study, but will be over-labeled according to local regulatory requirements as necessary. Calcium and vitamin D supplements will not be relabeled for the study.
Packaging, Labeling and Storage. Dynal shall be responsible for packaging and labeling the Products in accordance with cGMP and the Specifications. Xcyte shall provide Dynal with all the information to be included on the labels of the Products except the batch specific data, and Dynal shall order such labels based upon information provided to Dynal by Xcyte. Upon receipt of the blue print labels, Dynal shall send a sample of each to Xcyte for review and final approval. If Xcyte has any revisions to such samples, Xcyte shall notify Dynal promptly of such revisions, but in no event later than twenty-one (21) days after Xcyte’s receipt of each such sample from Dynal. If Xcyte does not provide Dynal with comments within such 21-day period, Dynal shall label the Products using the form of such labels as in the sample provided to Xcyte. Xcyte shall be solely responsible for ensuring that all labels for the Products are in compliance with applicable laws and regulations. Dynal shall store the Products in accordance with cGMP and the Specifications. All shipment of the Products will follow the cGMP requirements regarding the (i) packaging (ii) monitoring of the shipment in terms of temperature and time (iii) documentation. Xcyte is responsible for shipment validation.
Packaging, Labeling and Storage. The Antibodies will be filled aseptically in sterile containers by the Antibody Manufacturer and labeled with the description of the Antibody, including the lot number from the Antibody Manufacturer, volume and expiry date. Antibodies will be at all times stored under controlled, validated conditions according to the Specifications, and following the cGMP requirements. All shipment of Antibodies (from the Manufacturer to Xcyte and from Xcyte to Dynal) will follow the cGMP requirements regarding the (i) packaging (ii) monitoring of the shipment in terms of temperature and time (iii) documentation. Xcyte is responsible for shipment validation. The Antibodies will be shipped to Dynal CIP Oslo, Norway (Incoterms 1990).
Packaging, Labeling and Storage. All Product manufactured by APC shall be suitably stored, packaged and labeled in accordance with all Regulatory Standards, the Specifications and Revance’s written instructions, to protect it from degradation and minimize loss. Subject to the above, Product shall be minimally labeled: “Caution: New Investigational Material, for manufacturing, processing, or repackaging in the preparation of a new drug limited by Federal (or United States) Law to investigational use only.”.
Packaging, Labeling and Storage. Beovu 120mg/mL solution for injection in pre-filled syringe. Each pre-filled syringe contains 19.8mg of brolucizumab in 0.165mL solution. This provides a usable amount to deliver a single dose of 0.05mL containing 6mg of brolucizmab. For study drug in vials, the study drug will be withdrawn using aseptic technique. Study drug will be shipped to the site via overnight shipping using cold packs to maintain a temperature of 2° to 8° C. The Investigator, or an approved representative (e.g. study coordinator), will ensure that all study drugs are stored in a secured area, under recommended storage conditions and in accordance with applicable regulatory requirements. The shipping box is to be opened and stored immediately at the site in a refrigerator intended for investigational products at a temperature of 2° to 8°C. When vials are removed from the refrigerator, the solution should be visually inspected and it should have no evidence of turbidity. If particulates, cloudiness, or discoloration are visible, the vial must not be used. Exposure of the material to temperatures outside these limits, except for warming prior to administration, is not recommended and may result in loss of activity. Records of actual storage conditions (i.e. temperature log) at the study site must be maintained; and must include a record of the dates, when the refrigerator was checked, the initials of person checking, and the temperature.
