[Mohsinkhan101]

I just got appointment in new plant as QA executive,now the fact is that,,this company has never done any kind of validation what so ever,they dont have any SOP regarding validation,they dont have validation master plan,no instrument validtion,no process validation and also no cleaning validation,they just do the water validation,,now as a QA person,,now im confused where to start off things,,can anybody please just guide me through processes..

[Arkcon]

Really, it depends on what industry you're in, and under what jurisdiction your products fall.  However, some general documents:

https://www.google.com/search?q=FDA+method+validation&ie=utf-8&oe=utf-8

These are lengthy, general documents, and you can Google again for more specific information.  You have a lot of work ahead of you, and you will not find the answers in a forum posting.  But once you start, you'll see what you have to do.  Consider, you do the water validation... what does that entail?  Can you expand it to be a cleaning validation?  And then go farther?

[Mohsinkhan101]

our company is a liquid formulation company,we ordered solutions from vendors and use it our formulations ,it not a API plant. Cleaning validation is the most concerning about me,,i have google it but all i can get cleaning validation with API related issues,,i need cleaning validation for multivitamin syrups.i can not make an format for multivitamin syrup(vitmain B-complex, phosphate and calcium).

[Arkcon]

This is rapidly going to become a thread that goes nowhere, but I'll bite.  You need a  cleaning validation.  You'll want to validate that the equipment used to make your vitamin syrups is clean.  You'll have to work with industry specialists, and members of your own company -- how do they clean, and how do the (think) they know the cleaning is complete.  You'll have to determine the lowest amount of vitamin syrup components you can detect, you'll have to execute the cleaning, and verify that the possible contamination isn't detectable.  This is a lengthy, complicated process.  Can you even begin?  Give us some of your ideas.

[Mohsinkhan101]

hey,,sorry to bother you with a little information,,,ok,,we do cleaning as per cleaning SOP's of each equipments going through the process of making vitmain syrups,,as one equipment is tank,so,we rinse it water first,then with detergent(we have three class of detergents,Class A,B,C).then again with water twice,and during all this sample are collected every 15 minutes until no residue is detected.this detection is done by QC personnel,,after when QC gives a green signal to the production that its free from residue(checked by assay for all vitamins), Sainitization phase is proceeded i.e rinse with 70% alcohol.and then final rinsing with deionzed water and QC/QA perssnl inspetc tanks,and take samples from most undesirble places and go for chemical and microbiological testings. when QC informs there is no residue of alcohol or other stuffs.and tanks is sealed for the time being microbial results come by.

now my questions is when this calculation of MACO or LD50 or toxicological limits are applied and how..we just follow 10 ppm cretria,,we dont have structure to justify the limits we have created for acceptance criteria. and on which ever site i have seen,,they are giving protocols for API only,,how i put the MACO calucltn for liquid formualtions?

[Arkcon]

Hmmm... hard for me to know what maximum allowed carryover is allowed.  Most places I've been expect the cleaning validation to report contamination below the assay method's Limit Of Detection.  Likewise, toxicology limits don't really apply to your formulations.  Generally, your vitamin formulations shouldn't be toxic.  However, there should be no quantifiable carryover, simply because you're required to produce a product that isn't adulterated.  Even if the adulteration is in some ways harmless or desirable.  Unless you're talking about the cleaning agents.

[Mohsinkhan101]

Thank a lot sir,,i really do appreciate your help..and thanx for replying all the tym so quickly....and one more question sir,what you told about L.O.D stuff,,means we have to calculate LOD of each n every vitamin in the system and when we clean and collect rinse sample,,,we do analyse of each n every vitamin to chck whter its crossing acceptance criteria or not??...but how to set this acceptance limit..is it ok to follow 10 PPM..?? 

[Arkcon]

If you want to, you can just use 10 ppm, but when you're audited, they may demand that you justify that.  And I don't think that you can.  You may be able to "see" a "bμmp" in an analytical result that tells you something is there, you won't know exactly how much, because it will be almost lost in the noise.  But you'll know that you'll have to admit -- some of the last product is still there.