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By : Cut Adelia Rizfani 07131015

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

Basic element of quality management


An appropriate infrastructure or quality system

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

Good Manufacturing Practice for Pharmaceutical Product


All necessary facilities for GMP are provided including : Appropriately qualified and trained personnel Adequate premises and space Suitable equipment and services Correct materials, containers and label Approved procedures and instructions Suitable storage and transport

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.

Product Quality Review


Review of starting material and packaging materials

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.