Glossary
Three Sigma
What is three sigma in pharmaceutical industry?
In the pharmaceutical industry, Three sigma (3σ) refers to a quality control standard that ensures a process or product meets a specific level of quality, where:
Sigma (σ) represents the standard deviation of a normal distribution
Three Sigma (3σ) means that a process or product is within three standard deviations from the mean, which corresponds to a probability of 99.73% of being within the specified limits.
In other words, a 3σ process or product has a defect rate of no more than 2700 parts per million (ppm), which is considered acceptable in the pharmaceutical industry.
What are the benefits of having three sigma in pharma?
Here are the benefits of achieving a Three Sigma (3σ) level of quality in the pharmaceutical industry:
- Product Quality: 3σ ensures a high level of product quality, reducing the risk of defects, contamination, or other quality issues that could impact patient safety.
- Reduced Variability: 3σ processes exhibit minimal variability, resulting in consistent product performance and fewer batch failures.
- Increased Efficiency: With 3σ, pharmaceutical companies can optimize their processes, reducing waste, and minimizing the need for rework or scrap.
- Cost Savings: By minimizing defects and variability, companies can reduce costs associated with rework, scrap, and recalls.
- Enhanced Regulatory Compliance: 3σ demonstrates a strong commitment to quality and compliance, reducing the risk of regulatory issues and ensuring a smoother inspection process.