What strategy can be used to draft a risk assessment document for drug products, considering that the manufacturer has a portfolio of over 100 generic drugs (over 40 APIs used)? Should risk assessment for the APIs, excipients, FPP and packaging be combined into one document or they can be done as separate documents? Guidance documents only highlight what should be done but I am failing to find the “HOW”.
Nitrosamine Risk Assessment for Drug Product Manufacturer with 50+ APIs
@tchikwetu While I recognize that most of the guidance do not provide any guidance on how to prioritize the risk evaluation, ANVISA (Brazil) guidance contains criteria on how a manufacturer should prioritize their portfolio of products for risk assessment. What’s clear is that every products should carry it’s own assessment. While many pieces of information will be shared across several products the details of process, formulation, configuration, packages and chemistry will be unique to every pharmaceutical product.
Maybe @PauloEliandro can share bit more about how ANVISA define those criteria?
Separate risk assessment is needed for each drug product-there is no way to combine them.
As @GENERAPHARM says, there should be an individual risk assessment for product, but they can have some similarities as for the manufacturing process, excipients, etc…
Not sure I agree - many excipients can be found in a wide variety of products made by a wide range of processes.
You can find lactose in solid dosage forms made by direct compression, wet granulation - in tablets, in capsules and in dry powder inhalers for example. The same thing applies to MCC and different suppliers certainly have different levels of nitrite.
I firmly believe that this is going to put sourcing at the forefront of remediations for quite a number of at risk products.
Particularly for generic companies with a wide portfolio qualifying a new excipient supplier could become a real challenge