To what extent does the supply chain for APIs have to be documented? The EMA provides the answer

Pharmaceutical companies facing an official GMP inspection should be prepared that the Inspector will ask to see a complete documentation of the supply chain of the active ingredients (including appropriate risk assessments) - going back to the starting materials which were used for the synthesis of the APIs. In an update of the Question & Answer collection to the GMP Guide Part 1: "Basic requirements for medicinal products: Chapter 5: qualification of suppliers" the EMA has recently clarified this. According to this, medicinal product manufacturers have to demonstrate that each active ingredient delivery comes from an approved supplier, which, in turn, has to make available the complete documentation of the supply chain for the starting materials. The medicinal product manufacturer has to verify the entire supply chain on a regular basis according to risk-based criteria.

Below, the wording of the statement of the EMA:

"The supply chain for each active substance must be established back to the manufacture of the active substance starting materials. This should be documented and must be kept current. The risks associated with this supply chain should be formally documented. Control of each incoming consignment of active substance should include verification that it has been received from the approved supplier and approved manufacturer. The entire supply chain should be verified for a supplied batch periodically to establish a documented trail for the batch back to the manufacturer(s) of the active substance starting materials. The frequency of this verification should be based on risk."

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