Hello people, my greetings in advance
I would like to know if it is feasible to elaborate the cleaning agent (40% citric acid solution made with raw material that complies with usp requirements) or it is necessary to buy a commercial solution that has already been approved by the regulatory authority. It is a cost issue.
If it is possible to manufacture it, what controls should be done so that it is not objected to its use.
Thank you so much.
Best Regards.
Fabian.
While it can be done, there are other issues that come into play and are costly. With the outside manufacturer you only have to perform a QA audit (you can use a questionnaire) and approve them as a supplier. A regulatory inspector will not raise an eyebrow seeing a the name of a well known cleaning supplier.
But he will have questions if you make your own cleaning solution, like;
- Was it made in a cGMP fashion?
- Who reviewed the batch?
- Who approved the batch?
- Do they have the training, knowledge, and experience?
- On and on…
Do you want to make cleaning solutions or the API, or drug product? What does your mission statement say?
This is a prime example of being ‘pennywise and pound foolish’!
Agree!! I will try to prevent it from happening of course. Believe me when I tell you that the difference in cost is very important. (10 to 1 aprox)
My response:
Was it made in a cGMP fashion? in deed!
Who reviewed the batch? R&D, Production, QC, Quality Assurance, on and on…
Who approved the batch? QA, QC
Do they have the training, knowledge, and experience? Yes they have.
The solution is intended to clean API production equipment.
What I need to know is whether it is necessary to carry out stability studies (I suppose so) or some clinical analysis or some other test before implementing its use.
I know this has a cost that I must calculate.
Tnks!
No, you don’t have to perform ‘stability studies’. But you do have to show that the solution you make is effective in cleaning off your drug product, using the API concentration as a yardstick. In short you may be asked for TACT studies (Time, Action, Concentration, Temperature) in your development of this cleaning solution.