Can the (√n+1) Rule be accepted in Sampling Plans?
Recommendation

20/21 October 2026
Performance Evaluation and Monitoring for compliant Analytical Procedures and Processes
Is a sampling plan based on the (√n+1) rule acceptable for determining the correct number of samples? The Canadian health authority (Health Canada) listed this question in the section "Good Manufacturing Practices (GMP) Questions and Answers" of their website and answered it as follows:
Sampling plans and procedures must be statistically valid and based on scientifically sound sampling practices.
Among the important issues to be considered regarding the risks are:
- the previously determined classification of defects,
- the criticality of the material,
- the previous quality history of the supplier.
A sampling plan based on (√n+1) may generally be acceptable, e.g. for a large number of containers. However, such a sampling plan may pose a considerable risk of accepting defect goods when sampling a small number of containers, for example.
A documented justification is expected for all sampling plans.
Strictly speaking, these requirements only apply for der Canadian market, they can, however, be viewed as state of the art worldwide.
The question with its complete answer can be found in section "Raw Material Testing - C.02.009 & C.02.010" under Q7 - see
"Good Manufacturing Practices (GMP) Questions and Answers / Is the sampling plan based on the (√n+1) acceptable for identifying the number of containers of raw material to be sampled?"
Related GMP News
07.10.2026Analytical Quality Group Developments May through August 2026
07.10.2026Two New FDA Warning Letters Put OOS Investigations in Focus
07.10.2026Pharmeuropa: Revision Proposed for Chapter 2.5.32 on Coulometric Karl Fischer Water Determination
30.09.2026The Relationship between the BP and the Ph. Eur.
30.09.2026New Japanese Pharmacopoeia Drafts (September 2026) Open for Public Comment
30.09.2026EMA publishes final ICH M13B Guideline and Q&A on Bioequivalence

