Do any one has any idea about the reduced sampling plan for the starting materials used in the manufacturing of sterile products. Specially for sodium chloride where RAMAN will not work and container size is more. Can I go for a risk based approach considering
1. Manufacturer of the API is qualified and audited
2. Material is tested in both user site and manufacturer end.
3. At present material is fully tested and data of more than 10 batch is available
4. Identification test is same for both starting material and filled product
5. Material is directly received from manufacturer, no broker is involved.
1. Manufacturer of the API is qualified and audited
2. Material is tested in both user site and manufacturer end.
3. At present material is fully tested and data of more than 10 batch is available
4. Identification test is same for both starting material and filled product
5. Material is directly received from manufacturer, no broker is involved.
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