Examples of GMP Controls that May Be Relevant during QRM Exercises
| 1 | Eliminating the hazard, by redesigning the process or item in question, perhaps by replacing a component in the process with a component that does not present the same hazard. (Here, it is important that any risks presented by the new component are assessed and managed.) |
| 2 | Ensuring that effective procedures and checking activities are in place to ensure that unwanted steps and actions are avoided. |
| 3 | Training operators and other staff to comply with procedures and policies. |
| 4 | Adding fool-proof controls that cannot be by-passed via human error or by accidental or deliberate non-compliance with procedures. (An example of such a control would be a requirement for an operator to confirm the volume of a solvent to be added to a vessel by re-entering the volume required into a computer system controlling the transfer of the solvent.) This approach is sometimes referred to as mistake-proofing. |
| 5 | For equipment-related negative events or failure modes, improving preventative maintenance activities so that the probability of occurrence of the negative event or failure mode may be reduced. |
| 6 | Isolating the item, process, area, etc., in which the hazard may occur, so that the impact of the effects of the hazard may be reduced and contained. |
| 7 | Designing in redundancy/contingency controls so that if the negative event or failure mode occurs, there are control systems in place that reduce or counteract the effects of that negative event or failure mode. |
| 8 | Providing warning information to relevant people about the hazard or its potential effects. An example here is a warning on the label of an injectable product not to use the product if particulates are observed in the solution. |
| 9 | Building in new and improved detection mechanisms, so that if the negative event or failure mode occurs, it, or its effects, may be detected in an appropriate timeframe. |
| 10 | Where detection controls are important in controlling a risk, training operators to better detect the effects of the negative event or failure mode. |
Note: The first five controls are preventative in nature and the second five are protective in nature.