Transcription of General Guidelines on Good Manufacturing Practices
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General Guidelines on Good Manufacturing Practices
Guidelines ON good Manufacturing PRACTICE FOR TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS FIRST EDITION KUALA LUMPUR, MALAYSIA 2008 Guidelines on good Manufacturing Practice Page 2 of 87 for Traditional Medicines and Health Supplements; Malaysia, 1st Edition, 2008 Guidelines ON good Manufacturing PRACTICE FOR TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS INTRODUCTION Under the 'Control of Drugs and Cosmetics Regulations 1984' compliance with good Manufacturing Practice (GMP) is required as one of the conditions to be considered in the evaluation of applications for a Manufacturing License. Manufacture as defined in the Regulations includes: a) the making or assembling of the product, b) the enclosing or packing of the product in any container in a form suitable for administration or application, and the labelling of the container, and c) the carrying out of any process in the course of any of the foregoing activities.
Guidelines on Good Manufacturing Practice Page 5 of 87 for Traditional Medicines and Health Supplements; Malaysia, 1st Edition, 2008 QUALITY ASSURANCE (QA) 1.2 Quality Assurance is a wide-ranging concept which covers all matters
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