Supplier Evaluation and Change Control in Fetal Bovine Serum Replacement Branding Steps

1. Clarify the level of change and the division of responsibilities

Fetal bovine serum is a key raw material for cell culture, and changing brands usually requires a change control process.Quality departments, laboratory leaders and procurement personnel shall jointly assess the level of change.If the serum is used for in vitro diagnostic reagent research and development, cell therapy or biological product production, it is generally managed according to the change of key materials, and a verification protocol and acceptance criteria need to be formulated in advance.

II. Supplier Qualification and Quality System Audit

In the Fetal Bovine Serum Rebranding step, the supplier review should precede the sample test.Focus on checking whether the supplier has legal qualifications, stable supply and quality system documents.Certificates of origin, animal quarantine certificates, irradiation or filtration process instructions, sterility and mycoplasma test reports, etc. may be requested.For imported products, it is also necessary to pay attention to the integrity of cold chain transportation records and customs declaration materials.

Check the supplier's production address and registration information;

Understand the serum collection area and mixed batch strategy;

Evaluate the supplier's after-sales response and batch sampling capacity.

III. Sample Technical Evaluation and Batch Consistency Judgment

After obtaining the sample, in addition to the laboratory cell test, batch-to-batch consistency should also be evaluated.Generally, suppliers are required to provide quality inspection data for successive batches, focusing on fluctuations in common indicators such as endotoxin, hemoglobin, total protein, pH, and osmotic pressure.If there is a large difference between batches, even if a single batch test is passed, it may affect the long-term supply stability.

IV. Change Verification and Parallel Operation

For critical use serum, it is recommended to set up parallel transportation between new and old brands