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Quality Management
Quality Management
Principle
The pharmaceutical industries must manufacture
pharmaceutical products so as to ensure that they are fit for their intended use, comply with the requirement of the marketing authorization. The attainment of this quality objectiveis the responbility of senior who determine the quality policy
encompassing the organizational structure, procedures, process and resources Systematic actions necessary to ensure adequate confidence that a product will satisfy given requirements for quality
Quality Assurance
Quality assurance is a wide ranging concept which
covers all matters which individually or collectively influence the quality of the product. Quality assurance therefore incorporates good manufacturing practice plus other factor outside the scope of this guide
Quality Control
Quality control is that part of GMP which is concerned with sampling, spesification and testing and with the organization, documentation and release procedures which ensure the necessary.
used for the product Review of critical in process control and finished product result Review of all batches that failed to meet established Review of all chages carried out
References
National Agency of Drug and Food Control, 2006, Guidelines on Good Manufacturing Practice, Republic of Indonesia.