Label qualified person

The Canadian fabricator, packager/labeller, distributor or importer obtains copies of inspection reports of the health authority responsible for the inspection of the contractor. A written evaluation of the report is made by the fabricator, packager/labeller, distributor or importer, stating that from a review by a technically qualified person, the contractor is in conformance or non-conformance with the GMP Division of the Regulations. The evaluation is signed and dated by the person that undertook the review. The health authority report is considered insufficient to ascertain conformance or nonconformance if ... 

The correct disposal method for wastes is to put them in appropriately labeled waste containers. These containers should be placed in the hoods in the laboratory. The waste containers will be disposed of safely by qualified persons using approved protocols. 

The routes of administration should be the same as proposed in the protocol as well as by labeling. This, however, as in some of the studies, requires modifications (e.g., drench in lieu of medicated feeds). In order to minimize autolytic decomposition, necropsy should be performed promptly after death on all animals that die during the study. The necropsy should be performed by a qualified and experienced person. A complete physical examination should be performed, and baseline data should be collected by a qualified and trained worker. Data should be obtained prior to the start of the trial and at reasonable, predetermined intervals thereafter in accordance with the study protocol. 

The specimens should be collected by qualified personnel and each container into which a specimen is placed must bear a label with the name of the subject, the type of specimen in the container, the date and time of the collection of the specimens, and the signature of the person collecting the specimen. Forms and labels are usually developed to facilitate inventory of the specimens collected and to document the activities at the collection site. Frequently, a police officer is at the scene of the collection of the specimen and that officer should also append his or her signature to the labels and form. The specimens collected should be properly packaged with the proper documentation and case history if available and transferred to a forensic laboratory for analysis. 

Every person who fabricates or packages/labels a drug shall have a written sanitation program that shall be implemented under the supervision of qualified personnel. 

Printed supplies such as labels, brochures, inserts,labeled cartons, etc., shall be inspected by a Qualified Professional Person for comparison to a standard copy of the text. The printed supplies shall be further inspected for compliance with specifications for type, texture grade, fiber direction of paper stock, ink, glue, quality of printing, workmanship, and dimensional tolerances when applicable. 

Written procedures shall be established, maintained, and applied for the control of printed supplies such as labels, brochures, inserts, labelled cartons, etc. Procedures and control of labels and labelling shall be under the supervision of a Qualified Professional Person and shall include ... 

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