Cleaning Validation and different manufacturers of the same API

[Gray61]

Hi, just wanted to know if anyone has any experience in this. My company makes cough and cold OTC solid oral dosage tablets, one of our main ingredients is guaifenesin, an expectorant which has always been supplied by the same company. We granulate and blend the guaifenesin with the excipients and then compress the tablets at our facility but our granulator is unable to keep pace with our customers tablet demand. The company is looking at alternate suppliers granulating the guaifenesin with the excipients and then we would complete blending and compressing in our facility. (I hope that isn't too vague). But we have a new validation person that thinks we should repeat the cleaning validation on all equipment after processing with this alternate supplier material. The cleaning validation team says that it should make no difference where the material came from as since all the active and inactive ingredients are the same. We test for active ingredient residues using Total Organic Carbon. I would appreciate any thoughts on this.

LGray

 

[HEC]

LGray

I may be a bit off beam here, but your new Validation person is being conservative. If you change anything prove that it makes no diference is his/her attitude. This is probably the right stance to take, as a auditor would do a similar thing. From your post you are contracting out some of the granulation only of the process. One approach is to look at their validation study and show the granulated product you receive from them is identical in all respects to the in house granulated product. The main concern would be in relation to generation of fines, or a higher level of dusting from the contract material. Transport in bulk across town in the back of a truck may cause dust or fines, or other things that are different. Once you have established there is no difference the Validation person should be happy. Of course an abreviated cleaning validation program may be easier!

hutton4eng@picknowl.com.au



Mark Hutton

 

[Gray61]

Thanks for the help. Maybe this will help the cleaning validation team see the Validation persons point of view a little more clearly.

L Gray

 

[MedicineEng]

What will be your approach in terms of production?
Will you make batches of outsourced granulated blended with in-house granulated product or will you separate each origin (one batch in-house, a different batch outsourced)?

If you deal it independently, I believe that it is not big deal. You just need to have in your BPR for that production that you will start you production with the granulated material instead of granulating in-house.

If your mix, it might be a little bit trickier, but what you have to have for your subcontractor is the same acceptance levels than for your own granulation (particle size, water/solvent content, API content, etc.) and make the blending study. Another thing that you might need to know is if the granulation technology is the same. If you granulate with a fluid bed dryer, then to easy the blending process, your subcontractor should also granulate with a fluid bed dryer to avoid then different granulate characteristics.

Hope that helps

PR