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.