BACKGROUND AND INTRODUCTION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 11

1.2.1 Additional Points to Consider
People who are designing manufacturing processes and respective control strate-
gies need to realize the relative risk inherent in these process steps. In this case,
it is the relative risk of process failure that could adversely affect product quality
and patient safety. The unwanted effect on product quality is the loss of quality
attributes. Quality attributes are those elements or functions of the product that
define it.
For pharmaceutical products, these attributes include the following:
Strength —potency, efficacy, effectiveness
Safety —does not cause harm, contamination, loss of sterility
Purity —free of foreign substances, contamination
Identity —what it purports to be, lot number, expiry date
In the pharmaceutical industry, we are primarily concerned with risk to patient
safety or public welfare. Loss of product quality leads to loss of patient safety.
If the failure or unwanted event is found and removed before it can affect the
patient, then there is no harm. If there is no harm, then there is no risk. Therefore,
detection becomes an important element in determining relative risk.
Risk assessments and management techniques should be used to provide the
information needed to make sound decisions, but they should not be used to make
the decision itself. In other words, setting a predetermined decision based on a
numeric scoring from a risk assessment model and then blindly following that
outcome without further analysis and thought can lead to problems and biased
assessments.
For risk management to be useful, risk assessments must be as accurate as
possible. Therefore, objectiveness and unbiased assessment and analysis are key.
It is essential that companies take care of the following:
1. Avoid preconceived decisions or results.
2. Do not use risk assessment to validate a position or to justify a questionable
process.
3. Use diverse assessment team(s) to assure objectivity.
• Use experienced facilitator if necessary.
• Allow for adequate time, but do not overdo it.
4. Pay attention to the outcome.
• Aseptic process is an example.
5. Document for future reference.
6. Pay attention to results.
7. Plan for follow through and feedback.
8. Plan for communication.