About Lee Leichter Expertise Manufacturing, Outsourcing, Regulatory (FDA), Quality systems and problems, Exporting, Start-up Issues, strategic planning, Distribution, etc.
Experience Employment history: Over 25 years in the industry
We are a pharmaceutical manufacturing company presently producing haemodialysis concentrates (non sterile)
We are looking to start a new small facility for the manufacture of sterile Peritoneal Dialysis Solutions and are looking for sources of information on the design, execution and operation of such a unit under cGMP.
Any help would be greatly appreciated.
Answer Dear Mr. Shalan,
Hemodialysis concentrates are regulated as medical devices under the FDA regulations and would be subject to the Quality System Regualtion (QSR), 21 CFR Part 820 for "GMPs".
This is an area in which I am expert and can help you. It is my business as I am a consultant, but I wuld be glad to give you some free advice to get you started.
If you would like, send me your contact information to leichter@plbiomedical.com and I will contact you - or call me at my office at +1239-768-1118.
