Hi all, If we have different suppliers of the same raw ingredients should I do process validation for all of them , and if I change the vendor should I re-validate the process
Yes! This supplier should be included in your ‘process validation study’. You can have 1 supplier supplying a powdered raw material and the other supplying a crystal. Both can meet USP specifications but only one form is suitable for your manufacturing process. Thus, I am always ‘highly’ relunctant to change suppliers (the exception is the bankruptcy of the supplier).
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But if I have more than one supplier for the same powdered raw material should I re-validate the process ?
Process validation has historically followed the 3 run validation rule. I have always included various vendors/suppliers of raw material in the process validation matrix. Meaning, that at least 1 of the process validation runs include the alternative supplier.
In reality, this approach is not statistically significant (1 run is not really “reliable”). Also, if you have a few raw materials each with various suppliers, how can you possible test all the suppliers in all the combinations? You can’t. I think in this case, running a design of experiments helps. Also relying on benchtop analysis, or benchtop production of the product also helps (without making a full lot). Also a risk assessment or side-by-side review of the various vendors/suppliers/products also does wonderous work. Boomer_Chemist discussed one example a powdered raw vs a crytaline raw (etc.). Changing suppliers is a big stinking deal and often takes months/quarters/years.
Also, there will be stability requirements for this new raw material. The best approach is to discuss the stability testing requirements with validation and change management team to combine and consolidate activities. I was able to piggy-back stabilty test lots with validation lots and saved a ton of time and testing.
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