1.0 OBJECTIVE
To lay down the procedure for Trend analysis.2.0 SCOPE
This SOP shall be applicable to Quality Control Dept.3.0 RESPONSIBILITY
Supervisor Quality Control4.0 ACCOUNTABILITY
Sr. Manager Quality Assurance5.0 PROCEDURE
5.1 Trend analysis shall be carried out for all batches of key products manufactured in a year.5.2 List out all the important tests mentioned below which are likely to reflect on the process parameters.
Tablet: Assay, Uniformity of content, Dissolution if applicable, Impurity profile (if any) and yield.
Capsule: Assay, Uniformity of content, Dissolution if applicable and Impurity Profile (if any) & Yield.
Liquid: Assay, Fill volume, pH, Specific gravity and Yield.
5.3 Report in a tabular form all the values under each test.
5.4 Calculate average value, minimum value and maximum value.
5.5 Calculate Standard Deviation and Relative Standard Deviation (RSD) for assay.
5.6 The RSD of the observed assay and Content uniformity values shall not exceed 4%.
5.7 Significant deviation if any shall be investigated by Sr. Manager Quality Assurance in consultation with General Manager Technical Operation and documented in Trend Analysis report.
5.8 Corrective actions, if required, shall be taken in consultation with Production, Research and Development, Maintenance, and Quality Assurance department as the case may be.
5.9 The Trend Analysis report will be complied with Annual Product Review record and sent to General Manager Technical Services.
5.10 If outside vendor is selected for trend analysis, inform the findings to the concerned vendors.
5.11 If significant deviations are observed, conduct a fresh audit by Quality Assurance at the premises of the supplier.
5.12 Inform General Manager Technical Services about the observations and action required (if any).
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure6.2 QA: Quality Assurance
6.3 QC: Quality Control
6.4 Dept.: Department
6.5 RSD: Relative Standard Deviation
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