Quality Agreement For Raw Material

by admin on December 15, 2020

They must have appropriate controls in place to ensure that correct labels are affixed and that printed packaging materials are taken into account during a labelling operation. If the Canadian manufacturer receives them, a specific identity test must be performed. For an API, tests must be performed in accordance with Interpretation 11, Section C.02.009 “Commodity Control” (for example. B each container must be scanned and tested). This assumes that the U.S. site does not require reconditioning. In other words, the materials must be delivered in their original containers with the original labels and the certificate of analysis received by the seller. In accordance with Section C.02.020 “Records,” documents to be kept by the manufacturer, packer/labeler, distributor and importer must be kept on their premises in Canada. In particular, in the case of a distributor or importer, these documents are sometimes kept only in the premises of a consultant responsible for providing quality control services. They are therefore not available on the premises of the distributor or importer at the time of the inspection. Is this acceptable practice? Quality control is not limited to laboratory operations. It must be integrated into all activities and decisions related to the quality of the product. These requirements help ensure that your company and Health Canada, in the event of a product quality issue, have access to samples for a re-examination.

When a batch of a product manufactured in a country of mutual recognition (MRA) is divided into two separate batches, is it mandatory for the importer to obtain a separate lot certificate for each batch? If you are looking at electronic verification of all packaging materials printed on the packaging line, you may not need full coordination. To produce consistent quality medicines, you need to make sure that your equipment is suitable for the intended use and is working as intended. The production of sterile products is subject to specific requirements in order to minimize the risk of microbiological contamination and contamination of particles and pyrogens.

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