API GMP vs. Drug Product (DP) GMP
At the heart of GMP is the fundamental concept that a GMP is a GMP, no matter whether it is for a drug or for an API. A GMP is meant to inculcate best manufacturing practices, irrespective of whether a company is producing animal products, human use products, cosmetics, excipients, foods or whatever.
GMP is subjective
At the end of the day, you need to have a level of comfort and confidence that you are doing the right thing for your API or DP. There is a strong reason for which GMP’s are needed: There are several purification steps in the API. This said, there is challenge, because how and what is performed on each of these GMP’s can vary. For instance, what is expected in Q11 is not expected in API GMP under Q 7. It is in fact, due to the purification steps that you have greater flexibility over what you can do and what you cannot.
The major differences…
One major difference between GMP for API and GMP for DP is that no matter what you do; it is difficult to obtain a perfect drug. The “junk” is always there, meaning that the essence present in API is diluted or altered in the drug. The same impurity is much less likely to be present in API, because the API is rawer and purer and has a lot less additives.
Another important aspect to be kept in mind is that no purification is usually present in drug product manufacturing. The flexibility that you see in API GMP is acceptable even to FDA and other regulatory bodies.
Validation is usually expected for critical steps, processes or conditions in API unlike in the case of DP, where validation is expected for the entire process.
Cleaning validations may not always be required for API’s, unlike for DP. The basic thing a firm needs to be prepared to do is to document and be able to defend its practices under API GMP, since this allows some flexibility to do something different, something that DP does not afford.
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