These Good Manufacturing Practices for Active Pharmaceutical Ingredients are designed to facilitate compliance by the regulated industry and to enhance consistency in the application of the regulatory requirements. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess. The focus of these guidelines is on the manufacture of APIs sold in their final labeled container and/or used in the manufacture of finished dosage forms for human use. More specifically, they apply to the fabrication, packaging/labeling, testing, importation, distribution, wholesale, and re-packaging/re-labeling of APIs (including their intermediates).. The guide is available for download on the Health Canada website.
WEB source: Update on FDA and International GxP Compliance 2012
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