If so how to define limit for routine cleaning validation studies. How is it going to impact hold time study as each product has it's own impurities but in general only one worst case molecule is considered for study
There is a Maximum Allowable Cary Over (MACO) limit defined by current batch size and the next batch size. Info you can find on cleaning validation at J. Pharm. Biomed. Anal. 2017, 134:108-115.
MACO calculation mentioned is it with respect to API or is it with respect to degradant. I have gone through the website and did not find any such article. One sticker is available which is related to SS recovery. Please provide information related to degradant it if I misunderstood give clarity
Hi.
I recommend you:
- to use acceptance criterion of 3 logs reduction for product impurities, as stated for API in FDA, "guide to inspections of validation of cleaning processes" and HEALTH Canada, cleaning validation guidances. As API is always a worst case, this assumption is more than Ok for all others.
Before you will determine acceptance criterion:
- Make analysis what is the worst case material (hard for removal) from analytical point of view, write justification. Believe me they will check it during audits;
- perform cycle development to assure you will meet the pre-deterimined acceptance criterion.
Best wishes.
Ms. Ani thanks for your reply. I would like to ask you how do you calculate 3 log reduction for degradant?. Can you please explain in detail as I am unaware of it
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