Monday, November 29, 2010

Retention Of Old Record Of Quality Control)

1.0           Purpose       :   Provide an instruction for retention of old record of quality control department.

2.0              Objective  :  To provide a documented procedure retention of old record of quality control department.

3.0                Scope     :  This procedure is applicable for retention of old record of quality control department ---- Pharmaceuticals Ltd,A---- 
4.0         Responsibility  :
·    Primary      :   QC Chemist / QC-Officer
·     Secondary :  Overall: QC – In charge

5.0       Procedure   :
·        All the documents generated by quality control departments, should follow the following schedule & should be destroyed in presence of the responsible person after their retention period is over.
·        All the Standard Operating Procedures are to be retained for 2 years after they have been revised. After completion of 2 years, review the Standard Operating Procedures.
·        All the analytical reports (e.g. raw materials, packing materials, in-process / intermediates and finished products) are to be retained for 5 years.
·        All quality control reporting formats / logbooks are to be retained for 5 years.
All the specifications are to be retained for 2 year after they have been revised.

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