GOOD MANUFACTURING PRACTICES PRINCIPLES
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An active participation of the manufacturer for documentation, and implementation establishes proper management.
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For managing quality, the system should encompass well organized procedures,and resources which ensures that API will meet its standards for quality. All the activities must be documented.
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Depending upon the size of the organization, effective and responsible groups must be established that keep a check on the working environment in all aspects. This group performs the function of Quality Assurance/Quality Control Unit.
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The persons who are responsible/authorized for release of intermediates and APIs must be specified.
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All quality related activities must be recorded simultaneously.
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In case of deviations from standard procedures, explanation and documentation is required. Proper investigations must be done and conclusions should be drawn and documented.
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Before the satisfactory completion of evaluation by the quality units, materials should not be released unless there are specifications as in case, under quarantine described in section X(10).
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There should be procedures for notifying responsible management of regulatory inspections, GMP deficiencies,and other product related defects and the actions taken. In other words, quality related complaints and actions taken for them should be properly done and documented.
To maintain and comply with the GMPs is the work of Quality Units.
