Based on the risk of further verified

Professional answer about your risk analysis problems

Our senior professionalsPaul, Daniel,I'm very glad to answer your question by email.This week's blog said by Paul and validation of senior managers of a biological pharmaceutical company E-mail communication.

C: Paul, good afternoon

I have an appointment in the validation work has 26 years, but there are still a revalidation of equipment with several questions related to create strategies for the process.At present, I am revising our company to regularly review and validation program again.I have found that for temperature controlled storage unit/area/revalidation stability such as box, there are many data need to review.

Company before I took office, our annual test execution parameter distribution, as you know, doing so may be costly and time-consuming.I definitely want to revalidation of the process for us to find a method based on risk, but I have a clear understanding of the need for risk assessment.At first glance, each of the temperature controlled device and area seems to be very critical, so we need a year to verify again.But, in my study based on risk analysis for the test parameter distribution, and every year for revalidation doesn't seem to be necessary.

We have a continuous monitoring system and its equipment be calibrated every year.I am check all the initial validation, to make sure all tests have been executed correctly;From this intuition is a good first step.My question is -- when using risk-based approach to perform re-validation I what to do next steps?

Specifically, in our risk assessment, we need to ask what type of questions?

I think we can see trends from the continuous monitoring system history, the alarm off/frequency/length.I also consider to check the equipment preventive maintenance, in order to check the reliability of the motor and door gasket, such as device.I actually want is in the face of the audit and check there is a reasonable and reliable risk assessment.

Can you offer any advice?

Yours sincerely
C

Paul writes: respect of C,

Glad to help.The wind险评估是一种重要的工具。有时甚至更好，在某些情况下，风险评估还可以帮助节约资源。

If you do not see, we provide seminar on the topic of online in the link below:GxP environment risk assessment

For the important principle of risk assessment is scoring rules must betransparentandclear.

Risk assessment's aim is to make it clear enough, so you can rest assured, later on the same application to perform risk assessment of another person will get the same conclusion.Just the first detailed risk assessment, for reviewers and inspectors is good - because it is one of the important information related to your controlled area.

A good starting point is to create scoring rules.For example, the main function of the environment is what?It is used to store expensive products or replaceable laboratory reagents?To view another aspect is the environment standard.Whether it has strict control specification (for example: stable box)?Or whether it is for a single key parameter environment (for example: - 80 ° C, ultra-low temperature freezer)?

Used to three focus on the risk rating:
• storage?
• specification is what?
What is in the region, the parameter distribution history?

For parameter distribution history, I will go back to the knowledge about the calibration interval of text.Based on my experience, in the pharmaceutical industry is associated with this aspect of knowledge is inadequate.However, some equipment you actually do not need to perform calibration every year, you are advised to do so just because manufacturers.If every calibration of the equipment within the scope of its accuracy specifications to work properly, it can only be extended calibration interval based on the reason of risk.

We can apply the same logic to stable chest - if the parameter distribution test in good condition and pass the test, each time may can prolong the time interval between two revalidation.This application note"Humidity meter calibration and adjustment, the advantages and disadvantages of different methods"In the second paragraph on page 1, 3 column mentioned the situation.

In view of the risk assessment classification for the application

1. In a stable storage box?For example, a product is cheap or expensive?Or, if adding impurities, the product is high risk or low risk for patients?
2. It is difficult to realize specification?Such as stable box plus or minus 2 ° C and + / - 2% RH, or ultra-low temperature freezer for NMT to 60 ° C.
3. Deviation or equipment failure conditions of the be clear at a glance and can be detected?
4. Based on the research of the distribution of parameters in the region or device of what is known and recorded history?

You mentioned the records from the monitoring system of the device is the trend of history.Many things can learn from the historical trend - as we areThe story from the customerCan see.However, when the device is being opened and used, this may be related to a single point of similar parameter distribution in the...And you have to repeat the analysis, in order to prove that is to study on parameter distribution parameter distribution study or not.Create rules is a good idea.
If you have any follow-up questions, please let us know!

Shun ShangQi!
Paul, Daniel,

C: thank you, Paul.We also have a challenge...

Our plans for our temperature controlled room a regular audit schedule, but now we are trying to determine whether or not should be 24 or 72 hours (initial research for 72 hours) to perform temperature revalidation.

In addition, we should be based on the condition of static or dynamic condition parameter distribution study?We are inclined to static completely stable case study for 24 hours, because we already have 72 hours of study of the air chamber, and static/dynamic load conditions.We just need to confirm everything is still in a state of qualified.I face each other on the Internet has carried on the detailed investigation, related to the initial validation of a large number of information on the Internet (all aspects of validation/qualification), but related to implement revalidation/reconfirm information is very few.We also looked at from the WHO, the FDA and EU guidelines, but information about implement revalidation/reconfirm almost none.I am very grateful to your help, looking forward to hearing from you.

Yours sincerely
C

Paul writes: respect of C,

Your study is the same as mine.However, I can recommend a resource:ISPE study the parameters of the controlled room temperature distribution of good practice guide.

Summarize the relevant sections of this guide, we should every 1 to 5 years to parameter distribution.Based on the application of historical data and emergency degree we determine the time interval.

We record our findings, and use relevant information to create risk assessment.The guidelines also recommend the suggested method;Using the same sensor position under the condition of load parameter distribution in execution.To verify the loaded area can save a lot of time and effort!Your method without for the equipment fault or repair the situation is particularly true of history.