1.0 OBJECTIVE
To lay down the procedure to be followed in HPLC & GC analysis and documentation.
2.0 SCOPE
This SOP is applicable for the procedure to be followed for assay, dissolution, uniformity of dosage units and related substances/impurity by HPLC and for assay & residual solvents by GC. ...
In general, processing records for routine production batches should provide a complete account of the manufacturing process for each batch of biological product that demonstrates that it was produced, tested, and dispensed in accordance with approved procedures. In the case of vaccines, a batch processing ...