GB/T 27424-2020 in English

Uniformity assessment methodology

The standard requires the use of the F test method for statistical verification:

• Sampling volume: ≥25 packaging units
• Number of tests: 3 parallel measurements per unit
• Judgment criteria: F value 0.05(24,50)=1.74

The example data shows that the F values of the three levels of HSV-2 IgG quality control are 1.019/1.161/1.444, respectively, which all meet the uniformity requirements.

Multi-dimensional verification scheme

The standard recommends three verification methods:

1. Open bottle stability: 14 days of monitoring at 2-8℃ showed that the slope was greater than the critical value
2. Accelerated test: No significant changes were observed at 37℃ for 7 days
3. Long-term stability: The characteristic value fluctuation was less than 5% after 12 months of storage at -18℃

Key judgment formula: |b₁|＜t_0.95,n-2×s(b₁)

Laboratory application guide

1. Document system construction: Establish a research and development report template that includes the requirements of clause 11.1

2. Risk control points:

• Handle infectious materials in a biosafety level 2 or above environment
• The minimum sampling volume must not be less than the uniformity verification result
• Freeze-dried products must be repackaged and used immediately after reconstitution

3. Quality control chart application: It is recommended to use an XR control chart, with the total average value ±2S as the warning limit