Thank you very much for your help and your quick response.
The thing is that validation is very new to me. I work as a QP in a little factory and we produce natural drugs, but in Sweden they’re considered as pharmaceutical drugs and therefore has to follow GMP.
I have pharmaceutical background and my work as the QP, but haven’t work for the industry before so the only theoretical study about validations is from the university and after couple of years you loose that knowledge if you don’t use it. So you may say that I ‘m very new at this.
We have validated the production process but the cleaning process is a little bit more difficult.
Can somebody guide me what to do?
So far I have identified the areas to be studied but the thing is where and how to start. Do I start to establish a study protocol or???
As you can see I need a lot of help. So I am grateful for all the help I can get.
Thank you again[/quote]
Is there a cleaning Process for the blistering equipment? This process is the one that you will have to validate.
If there is an established cleaning process, then you need the following in order to proceed with your cleaning validation:
- Cleaning Validation Protocol
- Analytical Method Validation
- Recovery study
What we usually do is consider for the cleaning validation study the whole manufacturing - packaging line (i.e. mixer, mill, sieves, slugging equipment (if needed), compression machine and blistering equipment. The total surface area is used for the calculations of the Maximum Allowable residue. This MAR is used as Acceptance Criterion for all the swabs samples you are going to take.
The reason you need The Validation of the Analytical Method is because you will have to prove that the method to be used for the assay of the selected API of the worst case product (this is the concept used in CV) can be reliable at levels of 10 ppm or lower than that depending on your calculations.
The recovery factor is also needed so that to make sure that the result you get by each swab is corrected accordingly.
Finally the CV study needs also to be performed for the rinse sample of the equipments.
Some other studies we perform are the Bio Control for swabs (max 10cfu/swab) and rinse sample (max 10cfu/ml) plus the analysis of the water used for the cleaning process to ensure its conformance to Pharmacopoea.
Cleaning Validation is a huge concept which cannot be analysed in just a few lines.
If you be more precise I could be of more help to you.
Please do not hesitate to contact me again.