BCG vaccine used in UK is subjected to EU Official Medicines Control Laboratory for batch release. The control assays have been established in NIBSC include

in vitro tests on final lot:

• Appearance
• Identity (multiplex PCR assay and acid fast staining)
• Potency (cultural viable count and modified ATP assays)

in vivo tests on working seed lot:

• test for virulent mycobacteria
• excessive dermal reactivity

In addition, the manufacturing protocol of each final lot is subjected to critical evaluation.

The above tests are also applied to BCG for immunotherapy.