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Testing

A Proportionate Testing Plan, Not a Laboratory Shopping List

5 min read

More testing does not automatically mean better compliance. A good testing strategy starts with the product, risk profile, specifications and intended market.

1. Start With the Product

Consider:

  • Dosage form
  • Ingredients
  • Botanical materials
  • Microbiological risk
  • Physical characteristics
  • Chemical characteristics
  • Product shelf life
  • Packaging
  • Intended storage conditions
  • Target market

Testing should follow the product's actual requirements.

2. Separate Three Questions

Every test should answer a useful question:

Identity

Is the material or product what it is supposed to be?

Quality

Does it meet the defined specification?

Safety

Are relevant safety risks appropriately controlled?

Additional tests may be appropriate depending on the product.

3. Build the Specification Before Selecting Tests

A specification should define relevant acceptance criteria.

Depending on the product, this can include:

  • Appearance
  • Identification
  • Assay
  • Uniformity
  • Moisture
  • Microbiological parameters
  • Contaminants
  • Physical parameters
  • Other product-specific attributes

The specification should be scientifically and regulatorily justified.

4. Consider the Entire Supply Chain

Testing strategy should not focus only on finished products. Consider:

  1. 01Raw material
  2. 02In-process control
  3. 03Bulk / intermediate
  4. 04Finished product
  5. 05Stability / retention

The appropriate controls depend on the product and manufacturing process.

5. Avoid Both Extremes

Two common problems are:

Under-testing

Important risks or specifications are not adequately controlled.

Over-testing

Large numbers of tests are performed without a clear purpose, increasing cost and complexity.

A proportionate testing strategy balances risk, evidence, specifications and regulatory expectations.

Conclusion

The objective is not to create the longest laboratory test list.

It is to create a testing strategy that demonstrates that the product consistently meets its defined quality and safety requirements.

Need help structuring a product testing strategy?

Share the product, the specification and the destination markets. We will help scope a test plan proportionate to the risk.

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General information only. Regulatory requirements vary by product, jurisdiction and intended use. This article does not constitute legal or regulatory advice for a specific product.