SOP For trend analysis is described in this post which you can follow in the section of the Quality Assurance Department.
OBJECTIVE
To lay down the procedure for Trend analysis.
SCOPE
This SOP shall be applicable to Quality Control Department
RESPONSIBILITY
Q.A Officer
ACCOUNTABILITY
Manager Quality Assurance
PROCEDURE
Trend analysis must be performed for all batches of manufactured products annually.
List out all the important tests mentioned below which are likely to reflect on the process parameters.
Tablet: Assay, Uniformity of content, Dissolution and yield.
Capsule: Assay, Uniformity of content, Dissolution if applicable and Yield.
Liquid: Assay, Fill volume, pH, Specific gravity and Yield.
Report in a tabular form all the values under each test.
Calculate average value, minimum value and maximum value.
Calculate Standard Deviation and Relative Standard Deviation (RSD) for assay.
The RSD of the observed assay and Content uniformity values shall not exceed 4%.
Significant deviation shall be investigated by Manager Quality Assurance in consultation with General Manager Technical Operations and quality control Manager Plant Manager and production manager in Trend Analysis report.
Corrective actions, if required, shall be taken in consultation with Production, Research and Development, Maintenance, and Quality Assurance department.
The Trend Analysis report will be complied with Annual Product Review record and sent to General Manager Technical Services.
If outside vendor is selected for trend analysis, inform the findings to the concerned vendors.
If significant deviations are observed, conduct a fresh audit by Quality Assurance at the premises of the supplier.
Inform General Manager Technical Services about the observations and action required.