welcome after a long absence 🙂 At the beginning of the New Year, we will take up a topic that was the subject of an interesting discussion some time ago during an audit in a pharmaceutical company.
During the audit, the auditor indicated the need to maintain the production equipment ensuring class A (GMP)/ISO5 in the ON mode, with the proviso that the conditions of the cleanliness class should be maintained both at rest and in operation state, as is the case in other cleanliness classes, where maintaining the environmental parameters corresponds to the HVAC system.
The auditee refused to this remark, pointing to the constant monitoring of particles and microbiology during manufacturing operations and periodic testing of the device at rest. All tests results were correct and the sampling frequency schedule at rest, was developed based on the results of the risk analysis and drug-specific requirements.
So who was right? Auditor or audited?
The answer is not that simple 😉
In fact – in accordance with the GMP requirements, the A/ISO5 cleanliness class should be monitored continuously during the entire production operation of the medicinal product. It is clear that in the space surrounding class A, which mans – class B, and in other rooms, classes C and D – environmental parameters, i.e. humidity, temperature, number of air changes and pressure cascade – are maintained at a given level thanks to the ventilation system.
But, it is also a true that the EN ISO 14644 standard indicates the need to make the re-qualification in the event of a serious violation of the HVAC system, which may adversely affect the maintenance of the cleanliness class. This serious violation is, first of all, stopping the operation of the air handling unit! I always say that the cleanroom must not be turned off at night, weekend or on vacation – the rooms should work constantly so as to maintain the appropriate environmental parameters, and thus particle and microbiological cleanliness.
Regarding the continuous operation of the A-class device – however, we have a lot of information – we constantly monitor particle and microbiological cleanliness during the production session and we perform frequent tests at rest – much more often than in other classes!.
If we add to this the results of microbiology and quality control studies of a product for clinical use, no adverse events and no adverse reactions – we get quite a lot of evidence that the device provides class A in operation even when it is periodically turned off. Added to this is my favorite risk analysis – a cure for all evil;) – we can use an effective tool to verify the hypothesis that there is no need for continuous operation of the device 🙂
Who is closer to the truth now? Auditor or audited? 😉
Nice puzzle for the beginning of the New Year, isn’t it? 😉
I am curious about your opinions and conduct in similar cases :)!