Ask The Expert - Types of Risk - Assets

This session focuses on some of the main categories of RISK that you should consider as part of your RISK management process.  In addition, this session will provide you with best practice advice, theory.

Ask the Expert Types of Risk Q&A

Q 1- Regarding compliance risk, what is the industry practice on acceptable quality index for medical commodities? or is it a 100% score on quality parameters?

A – Drugs as part of medical products will be used as an illustration for this answer.

The acceptable quality index for a particular drug is defined in line with acceptable ranges of quality standard captured in the evaluation monograph (provides a structured method to review the major features of a drug product) for the drug from the developer of such drug. The monograph provides the reference standard for all quality control tests for mitigating the quality compliance risks associated with the drug.

The testing parameters for a drug in form of tablets amongst others include things such as:

1. Active ingredient content.
2. Average weight.
3. Dissolution rate.
4. Uniformity of weight.

The quality parameters score based on best practice is not just pegged at 100% for each of the above, but a range of scores which in the case of the active ingredients, could be a pass score that ranges from 90-110%.

Share your new knowledge with the HPA Community on Discuss